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Sample records for acute decompensation randomized

  1. Acute Decompensated Heart Failure: Contemporary Medical Management

    OpenAIRE

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

    2009-01-01

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

  2. 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.

  3. 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

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

    NARCIS (Netherlands)

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

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

    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

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

    International Nuclear Information System (INIS)

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

  8. 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.

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

    Science.gov (United States)

    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

  10. Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

    OpenAIRE

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

    2006-01-01

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

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

    OpenAIRE

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

    2008-01-01

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

  12. 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.

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

    Science.gov (United States)

    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.

  14. Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

    Science.gov (United States)

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

    2006-01-01

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

  15. Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

    Directory of Open Access Journals (Sweden)

    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

  16. 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.

  17. 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.

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

    Science.gov (United States)

    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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

    Science.gov (United States)

    Marenzi, Giancarlo; Morpurgo, Marco; Agostoni, Piergiuseppe

    2015-04-01

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

  1. Cardiorenal interactions in acute decompensated heart failure: contemporary concepts facing emerging controversies.

    Science.gov (United States)

    Kazory, Amir; Elkayam, Uri

    2014-12-01

    Simultaneous dysfunction of the heart and the kidney represents a distinct spectrum of disease states composed of complex clinical scenarios with adverse outcomes. Worsening renal function (WRF) in the setting of acute decompensated heart failure (ADHF) is one such clinical setup for which the underlying mechanisms are poorly understood. Apparent discrepancies exist between the emerging data on the cardiorenal interactions of patients with ADHF and contemporary concepts such as the low forward flow or the high backward pressure hypotheses. The findings of recent retrospective studies also suggest that apparent "improvement in renal function" might be yet another risk factor for untoward outcomes in this patient population, further challenging our current understanding of the cardiorenal interactions. Besides, these data do not seem to fully support our conventional thinking about other aspects of these interactions such as the independent adverse impact of WRF on the outcomes of patients with ADHF, pointing to congestion as a possibly overlooked factor. In this article, we provide an overview of these emerging controversial issues with the goal of identifying the areas where clinical research could be most helpful, because it is of paramount importance to characterize the pathways leading to WRF in ADHF to develop a mechanistically relevant management strategy. Although the paucity of data coupled with the complexity of this field precludes any firm conclusion, these discussions are meant to prompt clinicians and researchers to revisit a number of long-believed concepts surrounding the cardiorenal interactions in ADHF. PMID:25230240

  2. 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.

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

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    Leidi, Federica; Casella, Francesco; Cogliati, Chiara

    2016-06-01

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

  4. 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.

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

    Directory of Open Access Journals (Sweden)

    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

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

    OpenAIRE

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2016-06-01

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

  9. 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.

  10. [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.

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

    Directory of Open Access Journals (Sweden)

    McKiernan Patrick J

    2011-05-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2016-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Marrick L. Kukin

    2011-06-01

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

  15. 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.

  16. 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

  17. 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......BACKGROUND: The mortality of patients suffering from acute decompensated liver disease treated in the intensive care unit (ICU) varies between 50% and 100%. Previously published data suggest that liver-specific score systems are less accurate compared with the ICU-specific scoring systems acute...... alcoholic liver disease should be revised....

  18. Improving Survival in Decompensated Cirrhosis

    Directory of Open Access Journals (Sweden)

    Amar Nath Mukerji

    2012-01-01

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

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

    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

  20. 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

  1. 急性心力衰竭患者血清甲状旁腺激素水平与预后的相关性%Prognostic Value of Serum Parathyroid Hormone Level in Acute Decompensated Heart Failure

    Institute of Scientific and Technical Information of China (English)

    张瑾

    2015-01-01

    Objective To investigate the relationships between mortality and secrum parathyroid hor-mone ( PTH) level in acute decompensated heart failure ( HF) patients. Methods A total of 246 acute decompensated HF patients admitted to Sishui County People′s Hospital from Jul. 2011 to Aug. 2013 were included in the study,which were divided into three groups according to PTH level:low-normal PTH(10-40 ng/L) 34 cases,high-normal PTH(40-65 ng/L) 64 cases,high PTH( >65 ng/L) 148 cases. The demo-graphic,clinical and laboratory characteristics of the three groups were compared. Kaplan-Meier analysis and multivariate Cox regression analysis were used to assess the relevance between the PTH levels and mortality. Results Low-normal group(20. 6%) 1-year survival rate was significantly lower than the high-normal group (40. 6%)(P0. 05);multivariate COX regression analysis showed that age(HR =3. 73,95%CI 2. 10-7. 05),low concentrations of PTH(HR=3. 65,95%CI 1. 64-9. 28),hyponatremia(HR=2. 69,95%CI 1. 32-4. 96) and cystatin C(HR =4. 59,95%CI 2. 68-8. 96) were factors affecting the mortality. Conclusion In patients with acute decompensated HF,low-normal PTH on admission is closely associated with mortality.%目的:探讨血清甲状旁腺激素( PTH)水平与急性心力衰竭患者病死率的相关性。方法连续性纳入2011年7月至2013年8月入住泗水县人民医院心内科的急性失代偿性心力衰竭患者246例,根据血清 PTH 水平分为正常低值 PTH 组(10~40 ng/L )34例、正常高值 PTH 组(40~65 ng/L)64例和高值PTH组(>65 ng/L)148例。比较三组患者的一般资料和实验室相关指标,采用生存曲线和多因素COX回归分析评估PTH水平与患者的病死率的相关性。结果正常低值PTH组患者的1年生存率(20.6%)显著低于正常高值 PTH 组(40.6%)( P 0.05),多因素COX回归分析显示年龄(HR=3.73,95%CI 2.10~7.05)、低水平 PTH(HR=3.65,95%CI 1.64~9.28)、低钠血症(HR =2.69,95%CI 1.32~4.96)

  2. 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.

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

    OpenAIRE

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

    2016-01-01

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

  4. 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.)

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

    Institute of Scientific and Technical Information of China (English)

    胡康新; 陈伊; 胡佩

    2013-01-01

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

  6. 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

  7. 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.

  8. 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

  9. Treatment of Decompensated Alcoholic Liver Disease

    OpenAIRE

    John Menachery; Ajay Duseja

    2011-01-01

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

  10. 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 toler...

  11. 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

  12. 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

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

    OpenAIRE

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

    2014-01-01

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

  14. 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.

  15. Treatment of Decompensated Alcoholic Liver Disease

    Directory of Open Access Journals (Sweden)

    John Menachery

    2011-01-01

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

  16. 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.

  17. 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...

  18. 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

  19. 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.

  20. 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

    BACKGROUND: The optimal management of a torn anterior cruciate ligament (ACL) of the knee is unknown. METHODS: We conducted a randomized, controlled trial involving 121 young, active adults with acute ACL injury in which we compared two strategies: structured rehabilitation plus early ACL...

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

    Directory of Open Access Journals (Sweden)

    Soumya Patra

    2014-01-01

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

  2. 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.

  3. 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.

    2016-01-01

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

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

    OpenAIRE

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

    2015-01-01

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

  5. Enlarging Red Blood Cell Distribution Width During Hospitalization Identifies a Very High-Risk Subset of Acutely Decompensated Heart Failure Patients and Adds Valuable Prognostic Information on Top of Hemoconcentration

    Science.gov (United States)

    Ferreira, João Pedro; Girerd, Nicolas; Arrigo, Mattia; Medeiros, Pedro Bettencourt; Ricardo, Miguel Bento; Almeida, Tiago; Rola, Alexandre; Tolpannen, Heli; Laribi, Said; Gayat, Etienne; Mebazaa, Alexandre; Mueller, Christian; Zannad, Faiez; Rossignol, Patrick; Aragão, Irene

    2016-01-01

    Abstract Red blood cell distribution width (RDW) may serve as an integrative marker of pathological processes that portend worse prognosis in heart failure (HF). The prognostic value of RDW variation (ΔRDW) during hospitalization for acute heart failure (AHF) has yet to be studied. We retrospectively analyzed 2 independent cohorts: Centro Hospitalar do Porto (derivation cohort) and Lariboisière hospital (validation cohort). In the derivation cohort a total of 170 patients (age 76.2 ± 10.3 years) were included and in the validation cohort 332 patients were included (age 76.4 ± 12.2 years). In the derivation cohort the primary composite outcome of HF admission and/or cardiovascular death occurred in 78 (45.9%) patients during the 180-day follow-up period. Discharge RDW and ΔRDW were both increased when hemoglobin levels were lower; peripheral edema was also associated with increased discharge RDW (all P  15% at discharge was associated with a 2-fold increase in event rate, HR = 1.95 (1.05–3.62), P = 0.04, while a ΔRDW >0 also had a strong association with outcome, HR = 2.47 (1.35–4.51), P = 0.003. The addition of both discharge RDW > 15% and ΔRDW > 0 to hemoconcentration was associated with a significant improvement in the net reclassification index, NRI = 18.3 (4.3–43.7), P = 0.012. Overlapping results were found in the validation cohort. As validated in 2 independent AHF cohorts, an in-hospital RDW enlargement and an elevated RDW at discharge are associated with increased rates of mid-term events. RDW variables improve the risk stratification of these patients on top of well-established prognostic markers. PMID:27057905

  6. Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bernal Daniel DL

    2012-04-01

    Full Text Available Abstract Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible

  7. 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.

  8. 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.......02-0.99) ) than in the full sample of patients (HR = 0.20 (0.04-0.90) ), although not statistically significant. CONCLUSIONS: The SF-36 may be too broad an outcome measure in trials or treatments that seek to prevent depression following acute coronary syndrome. The SF-36 may, however, indicate who is more likely...... 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...

  9. Randomized controlled trial of interferential therapy and manipulative therapy for acute low back pain.

    OpenAIRE

    Hurley, D.A.; McDonough, S.M.; Dempster, Martin; Moore, A.P.; Baxter, G.D.

    2004-01-01

    Study Design. A multi-center assessor-blinded randomized clinical trial was conducted. Objectives. To investigate the relative effectiveness of interferential therapy and manipulative therapy for patients with acute low back pain when used as sole treatments and in combination. Summary of Background Data. Both manipulative therapy and interferential therapy are commonly used treatments for low back pain. Evidence for the effectiveness of manipulative therapy is available only for the short te...

  10. 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.

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    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.

  13. 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

  14. 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

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

    Science.gov (United States)

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

    2016-08-01

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

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

    Institute of Scientific and Technical Information of China (English)

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

    2012-01-01

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

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

    Directory of Open Access Journals (Sweden)

    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

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

    OpenAIRE

    Ellis, Jason; Cushing, Toby; Germain, Anne

    2015-01-01

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

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

    Science.gov (United States)

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

    2016-08-01

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

  20. 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.

  1. 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...... treated 23 hours after UV-B exposure and the areas treated with a moderate-potency corticosteroid 6 hours after UV-B exposure showed no significant reduction in redness. Conclusion: Treatment with topical moderate-potency or high-potency corticosteroids does not provide a clinically useful decrease......) was determined by the following equation: SIF=MED(minimal erythema dose) on treated skin/MED on nontreated skin. An SIF greater than 1 indicated an effect of topical corticosteroids in sunburn relief. Results: The SIFs in the areas treated with either topical corticosteroid 30 minutes before UV-B exposure...

  2. 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.

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

    Directory of Open Access Journals (Sweden)

    Sushila Godara

    2013-04-01

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

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

    OpenAIRE

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

    2015-01-01

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

  5. 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

  6. 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

  7. 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...

  8. The Acute Effect of Methylphenidate in Brazilian Male Children and Adolescents with ADHD: A Randomized Clinical Trial

    Science.gov (United States)

    Szobot, C. M.; Ketzer, C.; Parente, M. A.; Biederman, J.; Rohde, L. A.

    2004-01-01

    Objective: To evaluate the acute efficacy of methylphenidate (MPH) in Brazilian male children and adolescents with ADHD. Method: In a 4-day, double-blind, placebo-controlled, randomized, fix dose escalating, parallel-group trial, 36 ADHD children and adolescents were allocated to two groups: MPH (n = 19) and placebo (n = 17). Participants were…

  9. Preventive effect of eccentric training on acute hamstring injuries in men's soccer: A cluster-randomized controlled trial

    DEFF Research Database (Denmark)

    Petersen, Jesper; Thorborg, Kristian; Nielsen, Michael Bachmann;

    2011-01-01

    hamstring exercise on the rate of acute hamstring injuries in male soccer players. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Fifty Danish male professional and amateur soccer teams (942 players) were allocated to an intervention group (461 players) or a control group (481...... players). Players in the intervention group conducted a 10-week progressive eccentric training program followed by a weekly seasonal program, whereas players in the control group followed their usual training program. The main outcome measures were numbers of overall, new, and recurrent acute hamstring...... injuries during 1 full soccer season. Results: Fifty-two acute hamstring injuries in the control group compared with 15 injuries in the intervention group were registered. Comparing intervention versus the control group, overall acute hamstring injury rates per 100 player seasons were 3.8 versus 13...

  10. 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.

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

    Science.gov (United States)

    Costantino, Cosimo; Marangio, Emilio; Coruzzi, Gabriella

    2011-01-01

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

  12. Randomized Controlled Trial of Education and Feedback for Implementation of Guidelines for Acute Low Back Pain

    Science.gov (United States)

    Schectman, Joel M; Schroth, W Scott; Verme, Dante; Voss, John D

    2003-01-01

    OBJECTIVE The effect of clinical guidelines on resource utilization for complex conditions with substantial barriers to clinician behavior change has not been well studied. We report the impact of a multifaceted guideline implementation intervention on primary care clinician utilization of radiologic and specialty services for the care of acute low back pain. DESIGN Physician groups were randomized to receive guideline education and individual feedback, supporting patient education materials, both, or neither. The impact on guideline adherence and resource utilization was evaluated during the 12-month period before and after implementation. PARTICIPANTS Fourteen physician groups with 120 primary care physician and associate practitioners from 2 group model HMO practices. INTERVENTIONS Guideline implementation utilized an education/audit/feedback model with local peer opinion leaders. The patient education component included written and videotaped materials on the care of low back pain. MAIN RESULTS The clinician intervention was associated with an absolute increase in guideline-consistent behavior of 5.4% in the intervention group versus a decline of 2.7% in the control group (P = .04). The patient education intervention produced no significant change in guideline-consistent behavior, but was poorly adopted. Patient characteristics including duration of pain, prior history of low back pain, and number of visits during the illness episode were strong predictors of service utilization and guideline-consistent behavior. CONCLUSIONS Implementation of an education and feedback-supported acute low back pain care guideline for primary care clinicians was associated with an increase in guideline-consistent behavior. Patient education materials did not enhance guideline effectiveness. Implementation barriers could limit the utility of this approach in usual care setttings. PMID:14521638

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

    Institute of Scientific and Technical Information of China (English)

    陈瑜; 季顺民; 丁卫东

    2013-01-01

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

  14. 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...

  15. 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.

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

    OpenAIRE

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

    2008-01-01

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

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

    OpenAIRE

    Restan Asbjørn; Berg John E

    2005-01-01

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

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

    Science.gov (United States)

    Rerksuppaphol, Sanguansak; Rerksuppaphol, Lakkana

    2013-01-01

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

  19. A randomized paired comparison trial of cutaneous treatments for acute jellyfish (Carybdea alata) stings.

    Science.gov (United States)

    Nomura, Jason T; Sato, Renee L; Ahern, Reina M; Snow, Joanne L; Kuwaye, Todd T; Yamamoto, Loren G

    2002-11-01

    The objective of the study was to compare cutaneous treatments (heat, papain and vinegar) for acute jellyfish (Carybdea alata) stings. Healthy adult volunteer subjects received a single-tentacle jellyfish sting on each forearm. One forearm was treated with hot-water immersion (40-41 degrees C). This was compared with the other forearm, which was randomized to a comparison treatment of papain meat tenderizer or vinegar. Pain was measured at 0, 2, 4, 6, 8, 10, 15, and 20 minutes using a 10-cm visual analog scale (VAS). For 25 subject runs, the average VAS scores at t = 0 were 3.6 cm (hot water) and 3.7 cm (comparison treatment). At t = 4 minutes (2 minutes after treatment had started), the differences between hot-water and comparison group VAS scores were 2.1 cm versus 3.2 cm, respectively. The mean difference between hot-water and comparison treatments was 1.1 cm (95% confidence interval, 0.6 to 1.6). At t = 20 minutes (the end of the study period), the differences between hot-water and comparison group VAS scores were 0.2 cm versus 1.8 cm, respectively. The mean difference between hot-water and comparison treatments was 1.6 cm (95% confidence interval, 0.9 to 2.3). This study suggests that the most efficacious initial treatment for C alata jellyfish envenomation is hot-water immersion to the afflicted site. PMID:12442242

  20. 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.

  1. 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

  2. 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....

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

    OpenAIRE

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

    2016-01-01

    Intracutaneous sterile water injection (ISWI) is used for relief of low back pain during labor, acute attacks of urolithiasis, chronic neck and shoulder pain following whiplash injuries, and chronic myofascial pain syndrome. We conducted a randomized, double-blinded, placebo-controlled trial to evaluate the effect of ISWI for relief of acute low back pain (aLBP). A total of 68 patients (41 females and 27 males) between 18 and 55 years old experiencing aLBP with moderate to severe pain (scores...

  4. 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

    , strength exercises using hand weights and relaxation exercise. Individual health counseling sessions include a self directed home walk program with a step counter. The primary endpoint is functional performance/exercise capacity (6 minute walk distance). The secondary endpoints are submaximal VO2 max test...... 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...

  5. 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

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

    OpenAIRE

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

    2011-01-01

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

  7. 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.

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

    OpenAIRE

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

    2011-01-01

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

  9. 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

  10. 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.

  11. 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

  12. 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

  13. 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...

  14. 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.

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

    Directory of Open Access Journals (Sweden)

    Baumbach Sebastian Felix

    2013-01-01

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

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

    NARCIS (Netherlands)

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

    2007-01-01

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

  17. 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...

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

    Science.gov (United States)

    Chertoff, Jason; Nathoo, Sunina

    2016-01-01

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

  19. Acute pancreatitis complicating severe dengue

    OpenAIRE

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

    2014-01-01

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

  20. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction

    NARCIS (Netherlands)

    M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert); F.J.J. van de Werf (Frans); P.W. Armstrong (Paul); P.E. Aylward (Philip Edmund); G.I. Barbash; E.R. Bates (Eric); A. Betriu; J.H. Chesebro (James); J.J. Col (Jacques); D.P. de Bono (David); J.M. Gore (Joel); A.D. Guerci (Alan); J.R. Hampton (John)

    1993-01-01

    textabstractBACKGROUND: The relative efficacy of streptokinase and tissue plasminogen activator and the roles of intravenous as compared with subcutaneous heparin as adjunctive therapy in acute myocardial infarction are unresolved questions. The current trial was designed to compare new, aggressive

  1. High or low dose steroid therapy for acute renal transplant rejection after prophylactic OKT3 treatment: a prospective randomized study.

    Science.gov (United States)

    De Backer, D; Abramowicz, D; Goldman, M; De Pauw, L; Viseur, P; Vanherweghem, J L; Kinnaert, P; Vereerstraeten, P

    1992-01-01

    In this prospective randomized study, acute renal transplant rejections occurring in patients who received prophylactic OKT3 therapy were treated with either 3 pulses of 8 mg/kg methylprednisolone (MPS) in an alternate-day regimen (total dose 25 mg/kg in 1 week, H group, n = 24) or 5 daily pulses of 3 mg/kg MPS (total dose 17 mg/kg, L group, n = 22). Acute rejection was proven by biopsy in more than 85% of cases in both groups. No difference was observed in rejection reversal (H 88%, L 91%), graft losses in the following 3 months (H 11%, L 4%) or the time evolution of the serum creatinine levels. The number (H 14, L 21) as well as the nature and severity of infections were similar in both groups. Only one death occurred in a patient who received OKT3 rescue therapy for corticoresistant rejections and developed Epstein-Barr virus (EBV)-related lymphoma. In conclusion, low dose MPS pulses appear as effective and safe as a higher dose to reverse acute rejection occurring after OKT3 prophylaxis. Thus, we favour the use of the low dose regimen in these patients. PMID:14621839

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

    Directory of Open Access Journals (Sweden)

    Fafeng Cheng

    2012-01-01

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

  3. 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.

  4. A comparison of spinal manipulation methods and usual medical care for acute and sub-acute low back pain: a randomized clinical trial

    Science.gov (United States)

    Haas, Mitchell; Glick, Ronald; Stevans, Joel; Landsittel, Doug

    2014-01-01

    Study Design Randomized-controlled trial with follow-up to 6 months. Objective This was a comparative effectiveness trial of: manual-thrust manipulation (MTM) versus mechanical-assisted manipulation (MAM); and manipulation versus usual medical care (UMC). Summary of Background Data Low back pain (LBP) is one of the most common conditions seen in primary care and physical medicine practice. MTM is a common treatment for LBP. Claims that MAM is an effective alternative to MTM have yet to be substantiated. There is also question about the effectiveness of manipulation in acute and sub-acute LBP, as compared to UMC. Methods 107 adults with onset of LBP within the past 12 weeks were randomized to 1 of 3 treatment groups: MTM; MAM; or UMC. Outcome measures included the Oswestry LBP disability index (0 to 100 scale) and numeric pain rating (0 to 10 scale). Participants in the manipulation groups were treated twice weekly over 4 weeks; subjects in UMC were seen for 3 visits during this time. Outcome measures were captured at baseline, 4 weeks, 3 months and 6 months. Results Linear regression showed a statistically significant advantage of MTM at 4 weeks compared to MAM (disability = −8.1, p = .009; pain = −1.4, p = .002) and UMC (disability = −6.5, p = .032; pain = −1.7, p < .001). Responder analysis, defined as 30% and 50% reductions in Oswestry scores revealed a significantly greater proportion of responders at 4 weeks in MTM (76%; 50%) compared to MAM (50%; 16%) and UMC (48%; 39%).Similar between-group results were found for pain: MTM (94%; 76%); MAM (69%; 47%); and UMC (56%; 41%). No statistically significant group differences were found between MAM and UMC, and for any comparison at 3 or 6 months. Conclusions MTM provides greater short-term reductions in self-reported disability and pain scores compared to UMC or MAM. PMID:25423308

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

    Science.gov (United States)

    2011-01-01

    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 PMID:22151475

  6. 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

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

    Science.gov (United States)

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

    2015-10-01

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

  8. 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 ...

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

    Science.gov (United States)

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

    2015-02-01

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

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

    OpenAIRE

    Rerksuppaphol, Sanguansak; Rerksuppaphol, Lakkana

    2013-01-01

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

  11. Methylprednisolone pulse therapy in acute severe asthma. A randomized, double-blind study.

    Science.gov (United States)

    Engel, T; Dirksen, A; Frølund, L; Heinig, J H; Svendsen, U G; Pedersen, B K; Weeke, B

    1990-04-01

    Methylprednisolone pulse therapy (MPPT) has been shown to possess a long-lasting effect in other immune-inflammatory diseases without the well-known side effects caused by long-term treatment with glucocorticosteroids. In an attempt to reduce the long-term use of oral steroids in asthmatics, we conducted this double-blind, double-dummy study to compare the use of MPPT (1 g of methylprednisolone intravenously) (8 patients) with a short course of oral prednisolone (10 patients) in asthmatics presenting with acute severe asthma. Both treatments were effective in relieving the acute attack of asthma. The MPPT-treated patients did not show a faster resolution than did the orally treated group. No patients needed assisted ventilation, and no deaths occurred. One week after the treatment FEV1 tended to decrease in the methylprednisolone group compared with the oral prednisolone group (P = 0.06). The patients initially receiving MPPT needed supplementary prednisolone earlier and in higher doses than did the patients receiving oral prednisolone as initial treatment. At the end of the 12 weeks' study period, the groups reached identical FEV1. In conclusion, we did not find intravenous methylprednisolone superior to oral prednisolone in the treatment of acute attacks of severe asthma, but methylprednisolone pulse therapy had a shorter duration as regards protection against future asthma attacks. PMID:2183645

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

    Science.gov (United States)

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

    2014-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Aleksandra Zgierska

    2013-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

  15. 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

  16. 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.

  17. 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

  18. 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.

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

    Science.gov (United States)

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

    2016-03-01

    Intracutaneous sterile water injection (ISWI) is used for relief of low back pain during labor, acute attacks of urolithiasis, chronic neck and shoulder pain following whiplash injuries, and chronic myofascial pain syndrome. We conducted a randomized, double-blinded, placebo-controlled trial to evaluate the effect of ISWI for relief of acute low back pain (aLBP). A total of 68 patients (41 females and 27 males) between 18 and 55 years old experiencing aLBP with moderate to severe pain (scores ≥5 on an 11-point visual analogue scale [VAS]) were recruited and randomly assigned to receive either ISWIs (n=34) or intracutaneous isotonic saline injections (placebo treatment; n=34). The primary outcome was improvement in pain intensity using the VAS at 10, 45, and 90 min and 1 day after treatment. The secondary outcome was functional improvement, which was assessed using the Patient-Specific Functional Scale (PSFS) 1 day after treatment. The mean VAS score was significantly lower in the ISWI group than in the control group at 10, 45, and 90 min, and 1 day after injection (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. PMID:26840703

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

    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

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

    International Nuclear Information System (INIS)

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

  2. 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.

  3. The Effect of Electro-Acupuncture on Motor Function Recovery in Patients with Acute Cerebral Infarction: A Randomly Controlled Trial

    Institute of Scientific and Technical Information of China (English)

    裴建; 孙丽娟; 陈汝兴; 诸田明; 钱越洲; 袁东健

    2001-01-01

    The aim of this study is to investigate the effect of electro-acupuncture treatment in acute phase of cerebral infarction on the motor functions. In this randomly controlled trial, 86 patients were allocated to two groups, the experimental group given clinical and electro-acupuncture treatments for a period of 4 weeks, and the control group given clinical treatment plus active and/or passive functional exercise. The result showed that the level of impairment and disability in both groups were improvement according to the Chinese Stroke Scale, Brunnstrom-Fugl-Meyer score, and Barthel Index throughout the study and 3 months after. The motor functions and the activities of daily living (ADL) were improved significantly in the electro-acupuncture group as compared with the control group (P<0.05). Also, the results showed greater reduction of neurological deficit in the electro-acupuncture group than in the control group. Conclusion: Early acupuncture treatment for acute stroke patients may improve motor functions, and consequently the activities of daily living.

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

    Directory of Open Access Journals (Sweden)

    Fisher Beth E

    2010-10-01

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

  5. 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.

  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. Randomized controlled trials in industrial low back pain relating to return to work. Part 1. Acute interventions.

    Science.gov (United States)

    Scheer, S J; Radack, K L; O'Brien, D R

    1995-10-01

    Employers and insurers are interested in being able to use cost-effective interventions for returning injured workers to the workplace. Unfortunately, truly objective information is lacking. The purpose of this and two subsequent review articles was to perform thorough scrutiny and methodologic comparison among all obtainable, published randomized and controlled studies on low back pain (LBP) interventions leading to return to work. The study was confined to English language articles published from 1975 through 1993. Of more than 4,000 LBP citations, more than 500 were chosen for review. Of that number, 35 articles met the selection criteria of randomization, reasonable controls, and work return comparisons. This paper focuses on the 10 articles relating to interventions for acute (less than 4 weeks) LBP, and considers bed rest, exercise, spinal manipulation, back school, and case management. A 26-point quality system was used to compare the methodologic rigor of each article. This literature survey demonstrated the meager scientific foundations on which our industrial rehabilitation programs are based. PMID:7487440

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

    Science.gov (United States)

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

    1999-02-01

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

  9. 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).

  10. 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

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

    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

  12. 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

  13. 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

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

    DEFF Research Database (Denmark)

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

    2014-01-01

    . However, there is no information to date, on the efficacy or safety of artemisinin combination therapy when used for malaria treatment in SCD patients. METHODS: Children with SCD and acute uncomplicated malaria (n = 60) were randomized to treatment with artesunate-amodiaquine (AA), or artemether...

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

    NARCIS (Netherlands)

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

    2014-01-01

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

  16. No beneficial effects of coronary thrombectomy on left ventricular systolic and diastolic function in patients with acute S-T elevation myocardial infarction: a randomized clinical trial

    DEFF Research Database (Denmark)

    Andersen, Niels Holmark; Karlsen, Finn Michael; Gerdes, Christian;

    2007-01-01

    OBJECTIVE: We sought to evaluate the effect of acute coronary thrombectomy, as adjunctive treatment to primary percutaneous coronary intervention, on the systolic and diastolic left ventricular function, in patients with acute S-T elevation myocardial infarction. METHODS: In a prospective...... randomized study, patients with acute S-T elevation myocardial infarction were randomized to treatment with primary percutaneous coronary intervention with or without thrombectomy. Outcome measures were left ventricular volumes and ejection fraction in addition to systolic long-axis function, estimated from...... the tissue Doppler systolic velocities of the mitral ring. Diastolic function was assessed by mitral inflow and diastolic velocities of the mitral ring movement. RESULTS: Of the 215 patients included, 172 patients (80%) had a 30-day follow-up. There were no significant differences in ejection fraction...

  17. 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.

  18. 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.

  19. Effects of batroxobin with continuous transcranial Doppler monitoring in patients with acute cerebral stroke: a randomized controlled trial.

    Science.gov (United States)

    Yitao, He; Kefu, Ma; Bingshan, Tang; Xuejun, Fu; Ying, Zhan; Zhili, Cai; Xin, Jiang; Guo, Yi

    2014-11-01

    Our objective was to determine whether continuous transcranial Doppler (TCD) monitoring could safely enhance the efficacy of batroxobin, a thrombin-like enzyme extracted from Bothrops atrox moojeni venom, in the treatment for acute cerebral stroke beyond the thrombolytic time window. Ninety patients suffering an acute cerebral stroke were recruited into the study within 12 hours after the onset of symptoms. Patients were randomized to receive batroxobin with (target group) or without 1 hour of continuous TCD monitoring (control group). Clinical evaluation of stroke was based on the National Institutes of Health Stroke Scale (NIHSS) score, Barthel index (BI), Thrombolysis in Brain Ischemia score (TIBI), the incidence of advancing stroke, and the recurrence of cerebral infarction. The patients receiving continuous TCD monitoring showed significant improvement in NIHSS score at 57 days post treatment compared with the control. Similarly, patients receiving continuous TCD monitoring also showed significant improvement in BI at 3 months compared with the controls. Consistently, both the incidence of advancing stroke after 1 week and the incidence of stroke recurrence after 3 months were significantly lower in TCD monitored group than control group. Moreover, the safety of the employment of TCD monitoring in the treatment of these patients was confirmed as there was no significant difference of the incidence of intracranial hemorrhage at 1 week after the treatment between the target and control groups. Taken together, our study showed that batroxobin, in combination with continuous TCD monitoring at the middle cerebral artery, reduced the incidence of advancing stroke and stroke recurrence after treatment without adverse effects in terms of poststroke intracranial hemorrhage. PMID:24684297

  20. 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

  1. 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.

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

    Institute of Scientific and Technical Information of China (English)

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

    2013-01-01

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

  3. 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 TENS and 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. PMID:27457916

  4. Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, dan D-dimer Sebagai Prediktor Decompensated Disseminated Intravascular Coagulation Sisseminated pada Sepsis

    Directory of Open Access Journals (Sweden)

    Fenny

    2011-03-01

    Full Text Available Sepsis is a systemic response to infection especially in pneumonia case. Sepsis can cause complications such as disseminated intravascular coagulation (DIC which can be divided into compensated and decompensated DIC. The purpose of this study was to assess whether the value of prothrombin time (PT, activated partial thromboplastin time (aPTT, fibrinogen, and D-dimer levels can be used as predictors of decompensated DIC in sepsis patients. This study was conducted at the Laboratory of Clinical Pathology Rumah Sakit Hasan Sadikin Bandung since September 2008 to June 2010. Subjects were patients with sepsis caused by pneumonia. PT and aPTT values, fibrinogen, and D-dimer levels was recorded from all sepsis patients then patients were observed until diagnosed decompensated or non-decompensated DIC, then the value of PT, aPTT, fibrinogen and D-dimer levels in the group of decompensated DIC and non-decompensated DIC were analysed. This study used cohort design. Subjects were 39 sepsis patients (58% with outcome decompensated DIC and 28 sepsis patients (42% with outcome non-decompensated DIC. From the hemostasis parameter test out, it was found that PT, aPTT, and fibrinogen were the predictor of decompensated DIC in patients with sepsis with relative risk 240.500, 7.157, and 6.421; respectively. Conclusions, prothrombin time, aPTT, fibrinogen are the test to know coagulation activation. Hemostasis parameter to predict decompensated DIC in sepsis patients are the shorten PT, aPTT, and the increased fibrinogen

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

    Directory of Open Access Journals (Sweden)

    Paajanen Hannu

    2013-02-01

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

  6. Effect of paracetamol (acetaminophen) on body temperature in acute ischemic stroke: a double-blind, randomized phase II clinical trial

    NARCIS (Netherlands)

    D.W.J. Dippel (Diederik); E.J. van Breda (Eric); H.M.A. van Gemert (Maarten); H.B. van der Worp (Bart); R.J. Meijer (Ron); L.J. Kappelle (Jaap); P.J. Koudstaal (Peter Jan)

    2001-01-01

    textabstractBACKGROUND AND PURPOSE: Body temperature is a strong predictor of outcome in acute stroke. However, it is unknown whether antipyretic treatment leads to early and clinically worthwhile reduction of body temperature in patients with acute stroke, especially w

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

    OpenAIRE

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

    2014-01-01

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

  8. 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

    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...... differences were found. CONCLUSION: No significant effect on muscle mass was observed in this group of acutely ill old medical patients. High compliance was achieved with the dietary intervention, but resistance training was challenging. Clinical trials identifier NCT02077491....

  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

    International Nuclear Information System (INIS)

    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. 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.

  11. Determination of albumin transport rate between plasma and peritoneal space in decompensated cirrhosis

    DEFF Research Database (Denmark)

    Ring-Larsen, H; Henriksen, Jens Henrik Sahl

    1984-01-01

    Plasma-to-peritoneal transport rate of albumin (TERperit.space) was determined in eighteen patients with decompensated cirrhosis by sampling ascitic fluid after i.v. injection of 125I-labelled serum albumin. Median TERperit.space was 0.30% of the intravascular albumin mass (IVM) per hour (range 0...

  12. 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.

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

    NARCIS (Netherlands)

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

    2009-01-01

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

  14. 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.

  15. 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.

  16. 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.

  17. 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

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

    Directory of Open Access Journals (Sweden)

    Urbino Antonio

    2011-02-01

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

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

    OpenAIRE

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

    2013-01-01

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

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

    OpenAIRE

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

    2013-01-01

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

  1. 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.

  2. 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.

  3. 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

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

    Science.gov (United States)

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

    2014-01-01

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

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

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    Jens Tank

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

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

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    Michael S Okun

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

  7. Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617

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    Day Richard O

    2005-11-01

    Full Text Available Abstract Background Acute low back pain is a common condition resulting in pain and disability. Current national and international guidelines advocate general practitioner care including advice and paracetamol (4 g daily in otherwise well adults as the first line of care for people with acute low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs and spinal manipulative therapy (SMT are advocated in many guidelines as second line management options for patients with acute low back pain who are not recovering. No studies have explored the role of NSAIDs and/or SMT in addition to first line management for acute low back pain. The primary aim of this study is to investigate if NSAIDs and/or SMT in addition to general practitioner advice and paracetamol results in shorter recovery times for patients with acute low back pain. The secondary aims of the study are to evaluate whether the addition of SMT and/or NSAIDs influences pain, disability and global perceived effect at 1, 2, 4 and 12 weeks after onset of therapy for patients with significant acute low back pain. Methods/design This paper presents the rationale and design of a randomised controlled trial examining the addition of NSAIDs and/or SMT in 240 people who present to their general practitioner with significant acute low back pain.

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

    OpenAIRE

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2016-01-01

    Background The study of sepsis is hindered by its heterogeneous time course and evolution. A subgroup of patients with severe sepsis develops shock soon after the initiation of treatment while others present hypotensive. We sought to determine the incidence of hypotension after the initiation of treatment for sepsis, and characterize their clinical features and course. Methods A retrospective review of electronic medical record of all septic patients (n = 542) that met the definition of septic shock within 24 hours of admission (2011 - 2012) at an urban Veteran Affairs Hospital was performed. Subjects either had 1) initial normotension (INT) with hypotension developing within 24 hours or 2) initial hypotension (IH). Logistic regression was used to model associated factors of INT/IH. Results INT occurred in 62 patients (11%) with average initial blood pressure of 120/71 mm Hg and developed hypotension to 79/48 mm Hg. IH was identified in 52 patients (10%) with average presenting blood pressure of 81/46 mm Hg. INT showed evidence of increased sympathetic tone with significantly higher heart rate, blood pressure and temperature. INT patients were younger, more frequently on alpha-blockers, and more likely septic from pneumonia compared to IH patients. INT and IH patients had similar timing of antibiotic initiation, amount of 24-hour fluid resuscitation, vasopressor use, organ dysfunction and mortality at 28 days. Using alpha-blockers, being Caucasian, and having higher temperatures were independent predictors of INT. Conclusion INT is a distinctive presentation of septic shock characterized by rapid deterioration during early treatment. By further studying this subgroup, mediators of septic shock may be identified that clarify pathophysiology and provide timely targeted treatment. PMID:27429677

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

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    Ying Yue

    2015-01-01

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

  11. 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.)

  12. 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.

  13. Evaluation of a compact tinnitus therapy by electrophysiological tinnitus decompensation measures.

    Science.gov (United States)

    Low, Yin Fen; Argstatter, Heike; Bolay, Hans Volker; Strauss, Daniel J

    2008-01-01

    Large-scale neural correlates of the tinnitus decompensation have been identified by using wavelet phase stability criteria of single sweep sequences of auditory late responses (ALRs). Our previous work showed that the synchronization stability in ALR sequences might be used for objective quantification of the tinnitus decompensation and attention which link to Jastreboff tinnitus model. In this study, we intend to provide an objective evaluation for quantifying the effect of music therapy in tinnitus patients. We examined neural correlates of the attentional mechanism in single sweep sequences of ALRs in chronic tinnitus patients who underwent compact therapy course by using the maximum entropy auditory paradigm. Results by our measure showed that the extent of differentiation between attended and unattended conditions improved significantly after the therapy. It is concluded that the wavelet phase synchronization stability of ALRs single sweeps can be used for the objective evaluation of tinnitus therapies, in this case the compact tinnitus music therapy. PMID:19163872

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

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    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.

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

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    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 

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

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    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.

  17. 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.

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

    NARCIS (Netherlands)

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

    2008-01-01

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

  19. 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

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

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    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

  1. A randomized, phase 2 study investigating TRV130, a biased ligand of the μ-opioid receptor, for the intravenous treatment of acute pain.

    Science.gov (United States)

    Viscusi, Eugene R; Webster, Lynn; Kuss, Michael; Daniels, Stephen; Bolognese, James A; Zuckerman, Seth; Soergel, David G; Subach, Ruth Ann; Cook, Emily; Skobieranda, Franck

    2016-01-01

    Efficacy of conventional opioids can be limited by adverse events (AEs). TRV130 is a structurally novel biased ligand of the μ-opioid receptor that activates G protein signaling with little β-arrestin recruitment. In this phase 2, randomized, placebo- and active-controlled study, we investigated the efficacy and tolerability of TRV130 in acute pain after bunionectomy. We used an adaptive study design in which 144 patients experiencing moderate-to-severe acute pain after bunionectomy were randomized to receive double-blind TRV130, placebo, or morphine in a pilot phase. After pilot phase analysis, 195 patients were randomized to receive double-dummy TRV130 0.5, 1, 2, or 3 mg every 3 hours (q3h); placebo; or morphine 4 mg q4h intravenously. The primary end point was the time-weighted average change in numeric rating scale pain intensity over the 48-hour treatment period. Secondary end points included stopwatch and categorical assessments of pain relief. Safety and tolerability were also assessed. TRV130 2 and 3 mg q3h, and morphine 4 mg q4h produced statistically greater mean reductions in pain intensity than placebo over 48 hours (P opioid receptor activation is a promising target for development of novel analgesics.

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

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    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.

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

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

    2014-01-01

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

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

    OpenAIRE

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

    2007-01-01

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

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

    Institute of Scientific and Technical Information of China (English)

    邵素菊

    2013-01-01

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

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

    International Nuclear Information System (INIS)

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

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

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    Stefan Kahl

    2014-03-01

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

  9. 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.

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

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    Abd El Raheem Mostafa Dowidar

    2016-01-01

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

  11. 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

  12. 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.

  13. 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

  14. Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial: Study protocol for a randomized controlled trial

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    Kortram Kirsten

    2012-01-01

    Full Text Available Abstract Background Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. Methods/Design The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. Discussion The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. Trial Registration Netherlands Trial Register (NTR: NTR2666

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

  16. 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

  17. 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.

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

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    Bassi Uberto A

    2008-01-01

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

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

    Science.gov (United States)

    Plapler, Pérola Grinberg; Scheinberg, Morton Aaron; Ecclissato, Christina da Cunha; Bocchi de Oliveira, Monalisa Fernanda; Amazonas, Roberto Bleuel

    2016-01-01

    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 in efficacy and delivers faster pain relief than NA. PMID:27382251

  20. An open randomized controlled trial of noninvasive positive pressure ventilation in patients of acute on chronic hypercapnic respiratory failure in a general respiratory ward setting

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    Prasad R

    2007-01-01

    Full Text Available Objective : To compare the standard medical therapy (SMT and noninvasive posi-tive pressure ventilation (NPPV in acute on chronic hypercapnic respiratory fail-ure due to exacerbation of chronic obstructive pulmonary disease (COPD. Method : Between June 2002 and May 2003, 19 patients with acute on chronic hypercapnic respiratory failure were prospectively and randomly recruited to re-ceive either SMT (n=10 or NPPV plus SMT (n=9 in a general respiratory ward and followed up after 4 to 6 weeks after discharge. NPPV was given with a silicone cushioned nasal mask via a bilevel ventilator with initial pressure support of 5 cm of H 2 O. Results : At the time of randomization there was no significant difference in respiratory rate, PaO 2 , PaCO 2 , pH and HCO3 - , between the two groups. At 2 hours with SMT, there was significant improvement only in respiratory rate (p = 0.0000 and PaO 2 (p=0.0014. However with NPPV, respiratory rate (p=0.0000, PaO2 (p=0.0011, pH (0.0002, pulse rate (p=0.0329 and mean arterial pressure (p=0.0096 improved significantly at 2 hours while PaCO2 (p=0.0008 significantly improved at24 hours. Hospital stay was significantly shorter for NPPV group as compared to SMT group (9.63 + 1.4 days vs. 13.33 + 4.69 days, p < 0.05. There was 1 failure (12.5% in NPPV group as compared to 2 failures (20% in SMT group of which one was salvaged by NPPV. Conclusion : The study suggests that early application of NPPV in acute on chronic hypercapnic respiratory failure due to COPD facilitates improvement, favors early mobiliation and discharge from hospital.

  1. Aceclofenac–tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone

    Science.gov (United States)

    Chandurkar, Nitin; Chandanwale, A. S.; Ambade, Ratnakar; Gupta, Anil; Bartakke, Girish

    2009-01-01

    Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established. The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain. This double-blind, double-dummy, randomized, comparative, multicentric, parallel group study enrolled 197 patients of either sex in the age range of 18–70 years with acute low back pain. The patients were randomized to receive either aceclofenac (100 mg)–tizanidine (2 mg) b.i.d or aceclofenac (100 mg) alone b.i.d for 7 days. The primary efficacy outcomes were pain intensity (on movement, at rest and at night; on VAS scale) and pain relief (on a 5-point verbal rating scale). The secondary efficacy outcomes measures included functional impairment (modified Schober’s test and lateral body bending test) and patient’s and investigator’s global efficacy assessment. aceclofenac–tizanidine was significantly superior to aceclofenac for pain intensity (on movement, at rest and at night; P < 0.05) and pain relief (P = 0.00) on days 3 and 7. There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group (P < 0.05). There were significantly more number of patients with excellent to good response for the aceclofenac–tizanidine treatment as compared to aceclofenac alone (P = 0.00). Both the treatments were well tolerated. In this study, aceclofenac–tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain. PMID:19421791

  2. 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.

  3. 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

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

    OpenAIRE

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

    2013-01-01

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

  5. 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.

  6. 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.

  7. 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. PMID:24954134

  8. 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.

  9. 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.

  10. 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. PMID:24070990

  11. 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.

  12. 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.

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

    Science.gov (United States)

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

    2016-01-01

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

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

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    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

  15. The effectiveness of the McKenzie method in addition to first-line care for acute low back pain: a randomized controlled trial

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    Herbert Rob D

    2010-01-01

    Full Text Available Abstract Background Low back pain is a highly prevalent and disabling condition worldwide. Clinical guidelines for the management of patients with acute low back pain recommend first-line treatment consisting of advice, reassurance and simple analgesics. Exercise is also commonly prescribed to these patients. The primary aim of this study was to evaluate the short-term effect of adding the McKenzie method to the first-line care of patients with acute low back pain. Methods A multi-centre randomized controlled trial with a 3-month follow-up was conducted between September 2005 and June 2008. Patients seeking care for acute non-specific low back pain from primary care medical practices were screened. Eligible participants were assigned to receive a treatment programme based on the McKenzie method and first-line care (advice, reassurance and time-contingent acetaminophen or first-line care alone, for 3 weeks. Primary outcome measures included pain (0-10 Numeric Rating Scale over the first seven days, pain at 1 week, pain at 3 weeks and global perceived effect (-5 to 5 scale at 3 weeks. Treatment effects were estimated using linear mixed models. Results One hundred and forty-eight participants were randomized into study groups, of whom 138 (93% completed the last follow-up. The addition of the McKenzie method to first-line care produced statistically significant but small reductions in pain when compared to first-line care alone: mean of -0.4 points (95% confidence interval, -0.8 to -0.1 at 1 week, -0.7 points (95% confidence interval, -1.2 to -0.1 at 3 weeks, and -0.3 points (95% confidence interval, -0.5 to -0.0 over the first 7 days. Patients receiving the McKenzie method did not show additional effects on global perceived effect, disability, function or on the risk of persistent symptoms. These patients sought less additional health care than those receiving only first-line care (P = 0.002. Conclusions When added to the currently recommended

  16. The effectiveness of the McKenzie method in addition to first-line care for acute low back pain: a randomized controlled trial

    Science.gov (United States)

    2010-01-01

    Background Low back pain is a highly prevalent and disabling condition worldwide. Clinical guidelines for the management of patients with acute low back pain recommend first-line treatment consisting of advice, reassurance and simple analgesics. Exercise is also commonly prescribed to these patients. The primary aim of this study was to evaluate the short-term effect of adding the McKenzie method to the first-line care of patients with acute low back pain. Methods A multi-centre randomized controlled trial with a 3-month follow-up was conducted between September 2005 and June 2008. Patients seeking care for acute non-specific low back pain from primary care medical practices were screened. Eligible participants were assigned to receive a treatment programme based on the McKenzie method and first-line care (advice, reassurance and time-contingent acetaminophen) or first-line care alone, for 3 weeks. Primary outcome measures included pain (0-10 Numeric Rating Scale) over the first seven days, pain at 1 week, pain at 3 weeks and global perceived effect (-5 to 5 scale) at 3 weeks. Treatment effects were estimated using linear mixed models. Results One hundred and forty-eight participants were randomized into study groups, of whom 138 (93%) completed the last follow-up. The addition of the McKenzie method to first-line care produced statistically significant but small reductions in pain when compared to first-line care alone: mean of -0.4 points (95% confidence interval, -0.8 to -0.1) at 1 week, -0.7 points (95% confidence interval, -1.2 to -0.1) at 3 weeks, and -0.3 points (95% confidence interval, -0.5 to -0.0) over the first 7 days. Patients receiving the McKenzie method did not show additional effects on global perceived effect, disability, function or on the risk of persistent symptoms. These patients sought less additional health care than those receiving only first-line care (P = 0.002). Conclusions When added to the currently recommended first-line care of acute

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

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    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.

  18. 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

  19. 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.

  20. [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.

  1. 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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2004-09-01

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

  3. The acute effects of exercise on cortical excitation and psychosocial outcomes in men treated for prostate cancer: a randomized controlled trial

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    Daniel eSanta Mina

    2014-11-01

    Full Text Available Purpose: Regular exercise improves psychological wellbeing in men treated for prostate cancer. For this population and among cancer survivors in general, the effect of a single bout of exercise on self-report or objective measures of psychological wellbeing has not been examined. We examined the acute effect of a single bout of exercise on the cortical silent period (CSP and on self-reported mood in men that have received treatment for prostate cancer. Methods: Thirty-six prostate cancer survivors were randomly assigned to 60 minutes of low to moderate intensity exercise or to a control condition. Outcomes were assessed immediately before and after either the exercise or the control condition. Results: No significant differences in baseline CSP or mood were observed following the exercise session or control conditions. Participants with higher scores of trait anxiety had significantly shorter CSP at baseline, as well as those receiving androgen deprivation therapy. Age and baseline CSP had a low-moderate, but significant negative correlation. Changes in CSP following the exercise condition were strongly negatively correlated with changes in self-reported vigor. Conclusions: While we did not observe any acute effect of exercise on the CSP in this population, the associations between CSP and trait anxiety, age, and vigor are novel findings requiring further examination.Implications for Cancer Survivors: Exercise did not acutely affect our participants in measures of psychological wellbeing. Additional mechanisms to explain the chronic psychosocial benefits of exercise previously observed in men with prostate cancer require further exploration.Clinicaltrials.gov Identifier: NCT01715064 (http://clinicaltrials.gov/show/NCT01715064

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

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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

  5. 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

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

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    Emil Sundstrup

    2014-01-01

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

  7. 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.

  8. 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

  9. 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

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    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

  10. Application of Random Forest Survival Models to Increase Generalizability of Decision Trees: A Case Study in Acute Myocardial Infarction

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    Iman Yosefian

    2015-01-01

    Full Text Available Background. Tree models provide easily interpretable prognostic tool, but instable results. Two approaches to enhance the generalizability of the results are pruning and random survival forest (RSF. The aim of this study is to assess the generalizability of saturated tree (ST, pruned tree (PT, and RSF. Methods. Data of 607 patients was randomly divided into training and test set applying 10-fold cross-validation. Using training sets, all three models were applied. Using Log-Rank test, ST was constructed by searching for optimal cutoffs. PT was selected plotting error rate versus minimum sample size in terminal nodes. In construction of RSF, 1000 bootstrap samples were drawn from the training set. C-index and integrated Brier score (IBS statistic were used to compare models. Results. ST provides the most overoptimized statistics. Mean difference between C-index in training and test set was 0.237. Corresponding figure in PT and RSF was 0.054 and 0.007. In terms of IBS, the difference was 0.136 in ST, 0.021 in PT, and 0.0003 in RSF. Conclusion. Pruning of tree and assessment of its performance of a test set partially improve the generalizability of decision trees. RSF provides results that are highly generalizable.

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

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    Chea-Woo Elsa

    2004-09-01

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

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

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

    2014-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

  15. 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.

  16. 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.

  17. 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. PMID:27050843

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

    International Nuclear Information System (INIS)

    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

  19. 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.

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

    DEFF Research Database (Denmark)

    Carstensen, M; Møller, A M

    2010-01-01

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

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

    DEFF Research Database (Denmark)

    Carstensen, M; Møller, A M

    2010-01-01

    In experimental trials, ketamine has been shown to reduce hyperalgesia, prevent opioid tolerance, and lower morphine consumption. Clinical trials have found contradictory results. We performed a review of randomized, double-blinded clinical trials of ketamine added to opioid in i.v. patient......-controlled analgesia (PCA) for postoperative pain in order to clarify this controversy. Our primary aim was to compare the effectiveness and safety of postoperative administered ketamine in addition to opioid for i.v. PCA compared with i.v. PCA with opioid alone. Studies were identified from the Cochrane Library 2003...... for i.v. PCA was superior to i.v. PCA opioid alone. The combination allows a significant reduction in pain score, cumulative morphine consumption, and postoperative desaturation. The benefit of adding ketamine to morphine in i.v. PCA for orthopaedic or abdominal surgery remains unclear. Owing to huge...

  2. 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..

  3. 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.

  4. 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

  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. Collagen proportionate area of liver tissue determined by digital image analysis in patients with HBV-related decompensated cirrhosis

    Institute of Scientific and Technical Information of China (English)

    Shi-BinXie; ChaoMa; Chao-ShuangLin; YingZhang; Jian-YunZhu; Wei-MinKe

    2011-01-01

    BACKGROUND: The accurate assessment of the degree of hepatic fibrosis plays a critical role in guiding the diagnosis, treatment and prognostic assessment of chronic liver diseases. Liver biopsy is currently the most reliable method to evaluate the severity of hepatic fibrosis. However, liver biopsy is an invasive procedure associated with morbidity and mortality, and has several limitations in patients with decompensated cirrhosis. There is no report on the collagen proportionate area (CPA) of liver tissue in the decompensated stage of cirrhosis. This study aimed to determine the CPA of resected liver tissue samples from patients with HBV-related decompensated cirrhosis using digital image analysis, and to analyze the relationship between the CPA and liver functional reserve. METHODS: Fifty-three resected liver tissue samples from liver transplant patients with chronic hepatitis B-induced decompensated cirrhosis were stained with Masson's trichrome, and the CPA in these samples was quantitatively determined using digital image analysis. The values of relevant liver function justbeforelivertransplantation,theCPAinlivertissue,andtheir correlationwereanalyzed. RESULTS: The mean CPA at the decompensated stage of cirrhosis was 35.93±14.42% (11.24%-63.41%). The correlation coefficients of the CPA with a model for end-stage liver disease score, serum total bilirubin and international standard ratio of prothrombin B were 0.553, 0.519 and 0.533, respectively (P CONCLUSIONS: The degree of fibrosis may be correlated with the functional reserve. With the advancement of fibrosis, the liver functional reserve is attenuated accordingly.

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

    Directory of Open Access Journals (Sweden)

    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

  9. 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.

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

    Directory of Open Access Journals (Sweden)

    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

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

    Science.gov (United States)

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

    2014-09-01

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

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

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    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.

  13. 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.

  14. 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.

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

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    Ashwin Patkar

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

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

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    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.

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

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

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    Coccolini Federico

    2009-05-01

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

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

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    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

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

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

    2003-11-01

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

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

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    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

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

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    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

  3. 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

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    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

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

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    Bertrand Nalpas

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

  5. 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

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

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    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

  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. PMID:23639822

  8. 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.

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

    Science.gov (United States)

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

    1988-12-01

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

  10. 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.

  11. 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. PMID:26661344

  12. 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. PMID:24084510

  13. 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.

  14. 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

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

    Directory of Open Access Journals (Sweden)

    Fubing Ouyang

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

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

    OpenAIRE

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

    1984-01-01

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

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

    Science.gov (United States)

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

    2013-03-01

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

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

    Science.gov (United States)

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

    2016-08-01

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

  20. 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...

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

    Science.gov (United States)

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

    2015-12-01

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

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

    OpenAIRE

    Hessel Franz P

    2006-01-01

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

  3. 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

  4. 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

  5. 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

    OpenAIRE

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

    2010-01-01

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

  6. 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

  7. 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

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

    Directory of Open Access Journals (Sweden)

    Wisit Cheungpasitporn

    2014-01-01

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

  9. Randomized trial comparing liposomal daunorubicin with idarubicin as induction for pediatric acute myeloid leukemia: results from Study AML-BFM 2004.

    Science.gov (United States)

    Creutzig, Ursula; Zimmermann, Martin; Bourquin, Jean-Pierre; Dworzak, Michael N; Fleischhack, Gudrun; Graf, Norbert; Klingebiel, Thomas; Kremens, Bernhard; Lehrnbecher, Thomas; von Neuhoff, Christine; Ritter, Jörg; Sander, Annette; Schrauder, André; von Stackelberg, Arend; Starý, Jan; Reinhardt, Dirk

    2013-07-01

    Outcomes of patients with acute myeloid leukemia (AML) improve significantly by intensification of induction. To further intensify anthracycline dosage without increasing cardiotoxicity, we compared potentially less cardiotoxic liposomal daunorubicin (L-DNR) to idarubicin at a higher-than-equivalent dose (80 vs 12 mg/m(2) per day for 3 days) during induction. In the multicenter therapy-optimization trial AML-BFM 2004, 521 of 611 pediatric patients (85%) were randomly assigned to L-DNR or idarubicin induction. Five-year results in both treatment arms were similar (overall survival 76% ± 3% [L-DNR] vs 75% ± 3% [idarubicin], Plogrank = .65; event-free survival [EFS] 59% ± 3% vs 53% ± 3%, Plogrank = .25; cumulative incidence of relapse 29% ± 3% vs 31% ± 3%, P(Gray) = .75), as were EFS results for standard (72% ± 5% vs 68% ± 5%, Plogrank = .47) and high-risk (51% ± 4% vs 46% ± 4%, Plogrank = .45) patients. L-DNR resulted in significantly better probability of EFS in patients with t(8;21). Overall, treatment-related mortality was lower with L-DNR than idarubicin (2/257 vs 10/264 patients, P = .04). Grade 3/4 cardiotoxicity was rare after induction (4 L-DNR vs 5 idarubicin). Only 1 L-DNR and 3 idarubicin patients presented with subclinical or mild cardiomyopathy during follow-up. In conclusion, at the given dose, L-DNR has overall antileukemic activity comparable to idarubicin, promises to be more active in subgroups, and causes less treatment-related mortality. This trial was registered at www.clinicaltrials.gov as #NCT00111345. PMID:23704089

  10. 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.

  11. Effects of Dietary Honey andArdehCombination on Chemotherapy- Induced Gastrointestinal and Infectious Complications in Patients with Acute Myeloid Leukemia: A Double-Blind Randomized Clinical Trial.

    Science.gov (United States)

    Ebrahimi, Mahmoud; Allahyari, Abolghasem; Ebrahimi, Mohsen; Hesam, Hesam; Hosseini, Golkoo; Karimi, Mohammad; Rezaiean, Amin; Kazemi, Mohammad Reza

    2016-01-01

    We aimed to investigate the effects of dietary combination of honey and Ardeh on chemotherapy-induced complications in patients with acute myeloid leukemia (AML). A total of 107 AML patients who underwent chemotherapy for at least 30 consecutive dayswere recruited to this double-blind randomized placebo-controlled clinical-trial which was conducted in the Imam Reza and Ghaem teaching hospitals (Mashhad, Iran). They weredivided into two age and sex-matched groups: 58 treated and 49 untreated patients. A combination of 50 grams of honey and 150 grams of Ardehwas added to the treated group's diet for 30consecutive days, three times each day; while the untreated group received their regular diet.Both groups received their standard medication for AML as well. After one month, they were all examined and lab tests were done on them by an internist and laboratory technicians who were blinded to the subject allocations. Mean value of WBC count in treated group was significantly lower than that of untreated group. Duration of fever and admission in the hospital due to fever were both significantly lower in the treated group (P=0.014, P=0.032 respectively). Total gastrointestinal complications were significantly less in the treated group one month after therapy with the special honey and Ardeh compound.No unusual or unexpected side effects were observed. Honey and Ardehare easily accessible materials that can be helpfully administered in AML patientsreceiving chemotherapy, since their useful effects in ameliorating gastrointestinal complications and reducingfever and neutropenia in AML patients have been shown. PMID:27642340

  12. 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

  13. 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.

  14. 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.

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

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    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.

  16. 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. PMID:26871715

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

    OpenAIRE

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

    2015-01-01

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

  18. Acute right heart syndrome: Rescue treatment with inhaled nitric oxide

    Directory of Open Access Journals (Sweden)

    Ashish Garg

    2014-01-01

    Full Text Available Acute right heart syndrome is a common occurrence in intensive care units and is associated with a poor prognosis. There is lack of understanding of the involved pathophysiology, standard diagnostic protocols and treatment guidelines. Management goals include ensuring adequate right ventricle (RV filling, maximizing RV contraction and reducing RV afterload. We describe a 39-year-old female with acute decompensated right heart failure secondary to multiple causes. She was managed with inhaled nitric oxide. Her condition improved, which was evident by a decrease in her pulmonary artery systolic pressure on serial echocardiography, decreased requirement of vasopressors and successful weaning from the ventilator.

  19. 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

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

    Science.gov (United States)

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

    2016-09-01

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

  2. 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

  3. 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. PMID:27085901

  4. 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

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    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.

  5. 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.

  6. 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

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

    Institute of Scientific and Technical Information of China (English)

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

    2010-01-01

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

  8. 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.

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

    OpenAIRE

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2016-09-01

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

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

    Science.gov (United States)

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

    2016-09-01

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

  12. 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 between...... the plasma-to-peritoneal transport rate of albumin (index of 'lymph-imbalance') and the mass of intraperitoneal albumin (rlog = 0.82, P less than 0.001), indicating a significant role of 'lymph-imbalance' to sequestration of protein in the peritoneal cavity. Ascitic fluid albumin concentration was on...

  13. Sub-classification based specific movement control exercises are superior to general exercise in sub-acute low back pain when both are combined with manual therapy: A randomized controlled trial

    OpenAIRE

    Lehtola, Vesa; Luomajoki, Hannu; Leinonen, Ville; Gibbons, Sean; Airaksinen, Olavi

    2016-01-01

    Background Clinical guidelines recommend research on sub-groups of patients with low back pain (LBP) but, to date, only few studies have been published. One sub-group of LBP is movement control impairment (MCI) and clinical tests to identify this sub-group have been developed. Also, exercises appear to be beneficial for the management of chronic LBP (CLBP), but very little is known about the management of sub-acute LBP. Methods A randomized controlled trial (RCT) was conducted to compare the ...

  14. 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

  15. 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

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

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

    Science.gov (United States)

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

    2000-10-01

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

  17. 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.

  18. 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...

  19. 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

  20. Effectiveness of tailored support for people with Type 2 diabetes after a first acute coronary event: a multicentre randomized controlled trial (the Diacourse-ACE study)

    NARCIS (Netherlands)

    Kasteleyn, M.J.; Vos, R.C.; Rijken, M.; Schellevis, F.G.; Rutten, G.E.H.M.

    2016-01-01

    Aims: To evaluate the effectiveness of a tailored, supportive intervention strategy in influencing diabetes-related distress, health status, well-being and clinical outcomes in people with Type 2 diabetes shortly after a first acute coronary event. Methods: People with Type 2 diabetes and a recent f

  1. 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

    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 partic...

  2. 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...

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

    OpenAIRE

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

    2015-01-01

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

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

    Science.gov (United States)

    Jain, Ankur; Agrawal, Nikhil; Kazory, Amir

    2016-09-01

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

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

    Directory of Open Access Journals (Sweden)

    V. V. Yakusevich

    2015-09-01

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

  6. 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.

  7. 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....

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

    OpenAIRE

    Arun Jenish J; Lodha Rakesh; Kabra Sushil K

    2012-01-01

    Abstract Background There are no published studies that have compared bronchodilatory effect of inhaled budesonide/formoterol combination with budesonide/salbutamol delivered by metered dose inhaler with a spacer in acute exacerbation of asthma in children. We, therefore, compared the bronchodilatory effects of inhaled budesonide/formoterol (dose: 200 μg and 12 μg respectively) combination with budesonide (200 μg)/salbutamol (200 μg) administered by metered dose inhaler and spacer in children...

  9. 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 ... 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....

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

    OpenAIRE

    Mogollon, Jaime Andres; Bujold, Emmanuel; Lemieux, Simone; Bourdages, Mélodie; Blanchet, Claudine; Bazinet, Laurent; Couillard, Charles; Noël, Martin; Dodin, Sylvie

    2013-01-01

    Background Several randomized clinical trials (RCTs) indicate that flavanol-rich chocolate has beneficial effects on flow-mediated dilation (FMD) and blood pressure (BP). However, no RCTs have evaluated these outcomes in pregnant women. The objective of this 2-group, parallel, double-blind RCT was to examine the effects of flavanol-rich chocolate on FMD and BP in pregnant women with normal BP. Methods Forty-four healthy, pregnant women were randomized to the high-flavanol (n = 23) or low-flav...

  11. 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.

  12. Costs and Cost-effectiveness of Epidural Steroids for Acute Lumbosacral Radicular Syndrome in General Practice An Economic Evaluation Alongside a Pragmatic Randomized Control Trial

    NARCIS (Netherlands)

    Spijker-Huiges, Antje; Vermeulen, Karin; Winters, Jan C.; van Wijhe, Marten; van der Meer, Klaas

    2014-01-01

    Study Design. A pragmatic, randomized, controlled, single-blinded trial in Dutch general practice. Objective. Assessing the costs and cost-effectiveness of adding segmental epidural steroid injections to care as usual in radiculopathy in general practice. Summary of Background Data. Lumbosacral radi

  13. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication: A randomized controlled trial

    NARCIS (Netherlands)

    Wurdak, M.; Wolstein, J.; Kuntsche, E.N.

    2016-01-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized contro

  14. 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 at the...

  15. A randomized phase II/III study of adverse events between sequential (SEQ) versus simultaneous integrated boost (SIB) intensity modulated radiation therapy (IMRT) in nasopharyngeal carcinoma; preliminary result on acute adverse events

    International Nuclear Information System (INIS)

    To investigate acute and late toxicities comparing sequential (SEQ-IMRT) versus simultaneous integrated boost intensity modulated radiotherapy (SIB-IMRT) in nasopharyngeal carcinoma (NPC) patients. Newly diagnosed stage I-IVB NPC patients were randomized to receive SEQ-IMRT or SIB-IMRT, with or without chemotherapy. SEQ-IMRT consisted of two sequential radiation treatment plans: 2Gy x 25 fractions to low-risk planning target volume (PTV-LR) followed by 2Gy x 10 fractions to high-risk planning target volume (PTV-HR). In contrast, SIB-IMRT consisted of only one treatment plan: 2.12Gy and 1.7Gy x 33 fractions to PTV-HR and PTV-LR, respectively. Toxicities were evaluated according to CTCAE version 4.0. Between October 2010 and November 2013, 122 eligible patients were randomized between SEQ-IMRT (54 patients) and SIB-IMRT (68 patients). With median follow-up time of 16.8 months, there was no significant difference in toxicities between the two IMRT techniques. During chemoradiation, the most common grade 3–5 acute toxicities were mucositis (15.4 % vs 13.6 %, SEQ vs SIB, p = 0.788) followed by dysphagia (9.6 % vs 9.1 %, p = 1.000) and xerostomia (9.6 % vs 7.6 %, p = 0.748). During the adjuvant chemotherapy period, 25.6 % and 32.7 % experienced grade 3 weight loss in SEQ-IMRT and SIB-IMRT (p = 0.459). One-year overall survival (OS) and progression-free survival (PFS) were 95.8 % and 95.5 % in SEQ-IMRT and 98 % and 90.2 % in SIB-IMRT, respectively (p = 0.472 for OS and 0.069 for PFS). This randomized, phase II/III trial comparing SIB-IMRT versus SEQ-IMRT in NPC showed no statistically significant difference between both IMRT techniques in terms of acute adverse events. Short-term tumor control and survival outcome were promising

  16. 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.

  17. 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...

  18. 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

    complications or deaths. Our aim is to determine whether measurement of the blood level of the biomarker soluble urokinase plasminogen activator receptor (suPAR) can enhance early risk stratification leading to reduced mortality, lower rate of complications, and improved patient flow in acutely admitted adult......) 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...

  19. 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

  20. 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

    (n = 33) or placebo (n = 31) by concealed allocation. Patients were followed with strict recording of beneficial and harmful effects including masked assessment of time to complete wound closure. Analysis was carried out on an intention-to-treat basis. Median healing times were 54 days (interquartile......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...

  1. Scintigraphic evaluation of routine filterwire distal protection in percutaneous coronary intervention for acute ST-segment elevation myocardial infarction: a randomized controlled trial

    DEFF Research Database (Denmark)

    Kaltoft, Anne; Nielsen, Søren Steen; Terkelsen, Christian Juhl;

    2009-01-01

    AIM: Distal embolization during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) may result in reduced myocardial perfusion, infarct extension and impaired prognosis. In a prospective randomized trial, we assessed the effect of routine filterwire...... distal protection on scintigraphic estimated infarct size. METHODS AND RESULTS: The effect of routine filterwire distal protection was evaluated in 344 patients with STEMI <12 hours undergoing primary PCI. Patients were randomized to distal protection with a filterwire or standard PCI. The primary...... endpoint was myocardial infarct size measured by Sestamibi SPECT after 30 days (%). Secondary endpoints included myocardial salvage, ST-segment resolution (STR), myocardial biomarker release and major adverse cardiac and cerebral events. Baseline characteristics including area at risk (estimated by...

  2. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication — A randomized controlled trial

    OpenAIRE

    Wurdak, M.; Wolstein, J; Kuntsche, E.N.

    2015-01-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized controlled trial, 254 adolescents received a psychosocial intervention plus motive-tailored (intervention group; IG) or general exercises (control group; CG). Adolescents in the IG received exercises in ...

  3. Amisulpride plus valproate vs haloperidol plus valproate in the treatment of acute mania of bipolar I patients: a multicenter, open-label, randomized, comparative trial

    OpenAIRE

    Thomas, Pierre; Vieta, Eduard; ,

    2008-01-01

    The primary objective of this study was to compare the effectiveness of combination treatment of valproate and amisulpride with that of valproate and haloperidol in bipolar I disorder. Adult inpatients with a current manic episode fulfilling DSM-IV-TR diagnostic criteria for bipolar type I disorder were included. Patients were randomized to amisulpride (400–800 mg/day) or haloperidol (5–15 mg/day) for 3 months and all received valproate. The primary effectiveness criterion was the percentage ...

  4. Comparative study on the ACE inhibitors Quinapril and Captopril for the (Angiotensin converting enzyme) treatment of the decompensated cardiac insufficiency in dog

    International Nuclear Information System (INIS)

    In a randomized study of 52 dogs the efficacy and safety of captopril and quinapril in the treatment of canine heart failure is studied. The drugs were found to be comparably effective. The recommended dosage schedule for the short acting captopril is three times daily 0.5 mg/kg body weight. Quinapril belongs to a newer generation of ACE inhibitors with a longer half life than captopril and the treatment was started with a single dose of 0.5 mg/kg body weight. This dosage schedule was sufficient for the successful therapy of most of the dogs with heart failure phase II (12 of 13), but in 4 of 7 dogs with heart failure phase III and in all of the patients with phase IV the single dose had to be increased and/or the dosing interval of quinapril had to be shortened, because they still showed complaints due to heart failure. We recommend to adjust the dosage schedule of quinapril individually to the severity of heart failure. Therapy should be started once daily with an application of 0,5 mg/kg body weight and the dog should be controlled about one week later. If there are still symptoms of decompensated heart failure, the dosage may be increased gradually until a maximum dosage of 0.5 mg/kg three times daily. Especially for patients with severe heart failure we recommend at least when treatment is started a concomitant diuretic therapy. Echocardiographic evaluation of cardiac function shows if there is an indication for positive inotropic support witha digitalis glycoside. Quinapril, a novel inhibitor of the angiotensin-converting enzyme can ease the management of canine heart failure, because at least in dogs with mild to moderate heart failure dosing interval is longer compared with captopril. Moreover, quinapril is available as 5 mg tablets whereas the smallest captopril tablets contain 12.5 mg agent. It has to be mentioned that expenses for a treatment with ACE inhibitors are significantly higher than for a therapy with digitalis, so frequently above all the

  5. Mometasone Furoate Effect on Acute Skin Toxicity in Breast Cancer Patients Receiving Radiotherapy: A Phase III Double-Blind, Randomized Trial From the North Central Cancer Treatment Group N06C4

    International Nuclear Information System (INIS)

    Purpose: A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy. Methods and Materials: Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy. Results: A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group's maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002). Conclusion: Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo.

  6. Mometasone Furoate Effect on Acute Skin Toxicity in Breast Cancer Patients Receiving Radiotherapy: A Phase 3 Double-Blind, Randomized Trial from the North Central Cancer Treatment Group N06C4

    Science.gov (United States)

    Miller, Robert C.; Schwartz, David J.; Sloan, Jeff A.; Griffin, Patricia C.; Deming, Richard L.; Anders, Jon C.; Stoffel, Thomas J.; Haselow, Robert E.; Schaefer, Paul L.; Bearden, James D.; Atherton, Pamela J.; Loprinzi, Charles L.; Martenson, James A.

    2010-01-01

    Purpose A 2-arm, double-blinded, randomized trial to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy. Methods and Materials Patients with ductal carcinoma in situ or invasive breast carcinoma receiving external beam radiotherapy to breast or chest wall were randomly assigned to daily apply 0.1% MMF or placebo cream. Primary study end point was provider-assessed maximum grade of Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 radiation dermatitis. Secondary end points included provider-assessed CTCAE grade 3 or greater radiation dermatitis and adverse-event monitoring. Patient-reported outcome (PRO) measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and quality of life self-assessment. Assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy. Results In total, 176 patients were enrolled from September 21, 2007 through December 7, 2007. The provider-assessed primary end point showed no difference in mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs 1.3 for placebo; P=.18). CTCAE toxicity was greater in placebo group (P=.04), primarily from pruritus. For PRO measures, the maximum Skindex-16 score for MMF group showed less itching (P=.008), less irritation (P=.01), less symptom persistence or recurrence (P=.02), and less annoyance with skin problems (P=.04); the group's maximum Skin Toxicity Assessment Tool score showed less burning sensation (P=.02) and less itching (P=.002). Conclusion Patients receiving daily MMF during radiotherapy may experience reduced acute skin toxicity in comparison to placebo. PMID:20800381

  7. Efficacy of movement control exercises versus general exercises on recurrent sub-acute nonspecific low back pain in a sub-group of patients with movement control dysfunction. protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lehtola Vesa

    2012-04-01

    Full Text Available Abstract Background Practice guidelines recommend various types of exercise for chronic back pain but there have been few head-to-head comparisons of these interventions. General exercise seems to be an effective option for management of chronic low back pain (LBP but very little is known about the management of a sub-acute LBP within sub-groups. Recent research has developed clinical tests to identify a subgroup of patients with chronic non-specific LBP who have movement control dysfunction (MD. Method/Design We are conducting a randomized controlled trial (RCT to compare the effects of general exercise and specific movement control exercise (SMCE on disability and function in patients with MD within recurrent sub-acute LBP. The main outcome measure is the Roland Morris Disability Questionnaire. Discussion European clinical guideline for management of chronic LBP recommends that more research is required to develop tools to improve the classification and identification of specific clinical sub-groups of chronic LBP patients. Good quality RCTs are then needed to determine the effectiveness of specific interventions aimed at these specific target groups. This RCT aims to test the hypothesis whether patients within a sub-group of MD benefit more through a specific individually tailored movement control exercise program than through general exercises.

  8. 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

  9. Effect of a simple information booklet on pain persistence after an acute episode of low back pain: a non-randomized trial in a primary care setting.

    Directory of Open Access Journals (Sweden)

    Emmanuel Coudeyre

    Full Text Available Mass-media campaigns have been known to modify the outcome of low back pain (LBP. We assessed the impact on outcome of standardized written information on LBP given to patients with acute LBP.A 3-month pragmatic, multicenter controlled trial with geographic stratification.Primary care practice in France.2752 patients with acute LBP.An advice book on LBP (the "back book".The main outcome measure was persistence of LBP three months after baseline evaluation.2337 (85% patients were assessed at follow-up and 12.4% of participants reported persistent LBP. The absolute risk reduction of reporting persistent back pain in the intervention group was 3.6% lower than in the control group (10.5% vs. 14.1%; 95% confidence interval [-6.3% ; -1.0%]; p value adjusted for cluster effect = 0.01. Patients in the intervention group were more satisfied than those in the control group with the information they received about physical activities, when to consult their physician, and how to prevent a new episode of LBP. However, the number of patients who had taken sick leave was similar, as was the mean sick-leave duration, in both arms, and, among patients with persistent pain at follow-up, the intervention and control groups did not differ in disability or fear-avoidance beliefs.The level of improvement of an information booklet is modest, but the cost and complexity of the intervention is minimal. Therefore, the implications and generalizability of this intervention are substantial.ClinicalTrials.gov NCT00343057.

  10. 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.

  11. 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

  12. 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

  13. 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.).

  14. Diuretic treatment in decompensated cirrhosis and congestive heart failure: effect of posture

    DEFF Research Database (Denmark)

    Ring-Larsen, H; Henriksen, Jens Henrik Sahl; Wilken, C;

    1986-01-01

    The diuretic effect of the supine position was evaluated in six patients with cirrhosis and ascites and six with congestive cardiac failure. After fasting overnight in bed the patients received bumetanide 1 mg intravenously and were then immediately randomly assigned to either bed rest in the sup......The diuretic effect of the supine position was evaluated in six patients with cirrhosis and ascites and six with congestive cardiac failure. After fasting overnight in bed the patients received bumetanide 1 mg intravenously and were then immediately randomly assigned to either bed rest...... in the supine position or normal daily activity in the upright position for the next six hours. Two days later the procedure was repeated, the patients being assigned to the other posture. The diuretic response was similar in patients with heart failure and cirrhosis, and was significantly greater in the supine...

  15. 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

  16. A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD

    OpenAIRE

    Mahableshwarkar, Atul R.; Jacobsen, Paula L.; Chen, Yinzhong; Serenko, Michael; Trivedi, Madhukar H

    2015-01-01

    Rationale Vortioxetine has reduced depressive symptoms in adults with major depressive disorder (MDD) in multiple clinical trials. Objectives The aim of this study is to evaluate the efficacy, safety, and tolerability of vortioxetine 15 and 20 mg vs placebo in adults with MDD. Methods Patients were randomized 1:1:1:1 to vortioxetine 15 mg, vortioxetine 20 mg, duloxetine 60 mg (active reference), or placebo. The primary efficacy endpoint was mean change in Montgomery–Åsberg Depression Rating S...

  17. Randomized trial comparing intravenous immunoglobulin with methylprednisolone pulse therapy in acute idiopathic thrombocytopenic purpura. Danish I.T.P. Study Group.

    Science.gov (United States)

    Rosthøj, S; Nielsen, S; Pedersen, F K

    1996-08-01

    Forty-three children with newly diagnosed idiopathic thrombocytopenic purpura (ITP), platelet count (PC) below 20 x 10(9)l-1, and either continued bleeding or failure to show a spontaneous rise in the PC after a 3 day observation period were randomized to treatment with either intravenous immunoglobulin (IVIG) infusions 1 g kg-1 (n = 23) or intravenous methylprednisolone pulse therapy (MPPT) 30 mg kg-1 (n = 20) on two consecutive days. After 72 h, IVIG had induced greater platelet responses (mean PC 188 x 10(9) versus 77 x 10(9)l-1, 2p MPPT as the initial treatment for ITP. PMID:8863869

  18. 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

  19. Intraoperative Low-Dose Ketamine Infusion Reduces Acute Postoperative Pain Following Total Knee Replacement Surgery: A Prospective, Randomized Double-Blind Placebo-Controlled Trial

    International Nuclear Information System (INIS)

    Objective: To evaluate the effect of intraoperative low-dose ketamine with general anesthesia on postoperative pain after total knee replacement surgery. Study Design: A randomized, double-blind comparative study. Place and Duration of Study: Ankara Numune Training and Research Hospital, Turkey, from January and June 2011. Methodology: Sixty adults undergoing total knee arthroplasty were enrolled in this study. The patients were randomly allocated into two groups of equal size to receive either racemic ketamine infusion (6.25 g/kg/minute) or the same volume of saline. A visual analogue scale (VAS) was used to measure each patient's level of pain at 1, 3, 6, 12, and 24 hours after surgery. Time to first analgesic request, postoperative morphine consumption and the incidence of side effects were also recorded. Results: Low-dose ketamine infusion prolonged the time to first analgesic request. It also reduced postoperative cumulative morphine consumption at 1, 3, 6, 12, and 24 hours postsurgery (p < 0.001). Postoperative VAS scores were also significantly lower in the ketamine group than placebo, at all observation times. Incidences of side effects were similar in both study groups. Conclusion: Intraoperative continuous low-dose ketamine infusion reduced pain and postoperative analgesic consumption without affecting the incidence of side effects. (author)

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

    Directory of Open Access Journals (Sweden)

    Hessel Franz P

    2006-10-01

    Full Text Available Abstract Background Acute-on-chronic liver failure (ACLF is a life threatening acute decompensation of a pre-existing chronic liver disease. The artificial liver support system MARS is a new emerging therapeutic option possible to be implemented in routine care of these patients. The medical efficacy of MARS has been demonstrated in first clinical studies, but economic aspects have so far not been investigated. Objective of this study was to estimate the cost-effectiveness of MARS. Methods In a clinical cohort trial with a prospective follow-up of 3 years 33 ACLF-patients treated with MARS were compared to 46 controls. Survival, health-related quality of life as well as direct medical costs for in- and outpatient treatment from a health care system perspective were determined. Based on the differences in outcome and indirect costs the cost-effectiveness of MARS expressed as incremental costs per life year gained and incremental costs per QALY gained was estimated. Results The average initial intervention costs for MARS were 14600 EUR per patient treated. Direct medical costs over 3 years follow up were overall 40000 EUR per patient treated with MARS respectively 12700 EUR in controls. The 3 year survival rate after MARS was 52% compared to 17% in controls. Kaplan-Meier analysis of cumulated survival probability showed a highly significant difference in favour of MARS. Incremental costs per life-year gained were 31400 EUR; incremental costs per QALY gained were 47200 EUR. Conclusion The results after 3 years follow-up of the first economic evaluation study of MARS based on empirical patient data are presented. Although high initial treatment costs for MARS occur the significantly better survival seen in this study led to reasonable costs per live year gained. Further randomized controlled trials investigating the medical efficacy and the cost-effectiveness are recommended.

  1. 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

  2. 重组人生长激素和人血白蛋白对肝硬化失代偿的疗效比较%Therapeutic Effect Comparison of Recombinant Human Growth Hormone and Human Serum Albumin in Decompensative Liver Cirrhosis

    Institute of Scientific and Technical Information of China (English)

    刘慧; 邱小文

    2011-01-01

    目的 考察重组人生长激素与人血白蛋白对失代偿期肝硬化的治疗效果.方法 将42例白蛋白低于35g/L的失代偿期肝硬化患者随机分为两组,生长激素治疗组:20例,予重组人生长激素4IU,肌注,1次/2 d,疗程30天;白蛋白治疗组:22例,予20%人血白蛋白50 ml,静滴,2次/周,疗程30天.两组患者同时予相同保肝、对症治疗.于治疗第15天、30天、60天、90天测定各项指标.结果 15天时,白蛋白组血清白蛋白含量上升(P<0.05);30天时,两组患者血清白蛋白含量均上升(P<0.05);60天后,生长激素治疗组血清白蛋白水平升至最高点,白蛋白治疗组较前降低,两组间差异有统计学意义(P<0.01);90天后生长激素治疗组血清白蛋白含量仍维持较高,且肝功能好转,而白蛋白治疗组降至治疗前水平.结论 重组人生长激素与人血白蛋白均可明显提高失代偿期肝硬化血清白蛋白水平,但重组人生长激素,对肝硬化失代偿的治疗作用,中远期疗效更好.%Objective To compare the therapeutic effects of recombinant human growth hormone and human serum albumin on decompensative liver cirrhosis.Methods Forty-two patients diagnosed as decompensative liver cirrhosis with sera albumin below 35 g/L, were randomly divided into two groups.Besides conventional liver-protecting treatment, 20 were treated by recombinant human growth hormone 4 IU, intramuscular injection, once every two days, 30 days as a period of treatment; 22 cases were treated by 20% human serum albumin 50 ml, intravenous injection, twice a week, 30 days as a period of treatment.On 15, 30, 60 and 90 days of the treatment, albumin, alanine aminotransferase (ALT) and others indexes were tested.Results On the 15th day, the serum albumin was increased only in albumin group (P<0.05).On the 30th day, the serum albumin was increased in both groups (P<0.05).But on the 60th day, the serum albumin remained to increase and reached to peak in growth

  3. 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.

  4. Early Indication of Decompensated Heart Failure in Patients on Home-Telemonitoring: A Comparison of Prediction Algorithms Based on Daily Weight and Noninvasive Transthoracic Bio-impedance

    OpenAIRE

    Cuba Gyllensten, Illapha; Alberto G Bonomi; Goode, Kevin M.; Reiter, Harald; Habetha, Joerg; Amft, Oliver; Cleland, John GF

    2016-01-01

    Background Heart Failure (HF) is a common reason for hospitalization. Admissions might be prevented by early detection of and intervention for decompensation. Conventionally, changes in weight, a possible measure of fluid accumulation, have been used to detect deterioration. Transthoracic impedance may be a more sensitive and accurate measure of fluid accumulation. Objective In this study, we review previously proposed predictive algorithms using body weight and noninvasive transthoracic bio-...

  5. The impact of therapy for childhood acute lymphoblastic leukaemia on intelligence quotients; results of the risk-stratified randomized central nervous system treatment trial MRC UKALL XI

    Directory of Open Access Journals (Sweden)

    Vargha-Khadem Faraneh

    2011-10-01

    Full Text Available Abstract Background The MRC UKALLXI trial tested the efficacy of different central nervous system (CNS directed therapies in childhood acute lymphoblastic leukaemia (ALL. To evaluate morbidity 555/1826 randomised children underwent prospective psychological evaluations. Full Scale, verbal and performance IQs were measured at 5 months, 3 years and 5 years. Scores were compared in; (1 all patients (n = 555 versus related controls (n = 311, (2 low-risk children (presenting white cell count (WCC 9/l randomised to intrathecal methotrexate (n = 197 versus intrathecal and high-dose intravenous methotrexate (HDM (n = 202, and (3 high-risk children (WCC ≥ 50 × 109/l, age ≥ 2 years randomised to HDM (n = 79 versus cranial irradiation (n = 77. Results There were no significant differences in IQ scores between the treatment arms in either low- or high-risk groups. Despite similar scores at baseline, results at 3 and 5 years showed a significant reduction of between 3.6 and 7.3 points in all three IQ scores in all patient groups compared to controls (P Conclusion Children with ALL are at risk of CNS morbidity, regardless of the mode of CNS-directed therapy. Further work needs to identify individuals at high-risk of adverse CNS outcomes. Trial registration ISRCTN: ISRCTN16757172

  6. 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.

  7. 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

  8. 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.

  9. AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR HIGH-RISK ACUTE LYMPHOBLASTIC LEUKEMIA: NON-RANDOMIZED STUDY WITH A MAXIMUM FOLLOW-UP OF MORE THAN 22 YEARS

    Directory of Open Access Journals (Sweden)

    Grzegorz Helbig

    2014-06-01

    Full Text Available Objective. To evaluate the efficacy and toxicity of autologous hematopoietic stem cell transplantation (AHSCT for high-risk acute lymphoblastic leukemia (ALL. Material and methods. Overall, 128 high-risk ALL patients at a median age of 26 years (range 18-56 years at diagnosis received AHSCT between 1991-2008. Induction treatment was anthracycline-based in all patients. Conditioning regimen consisted of CAV (cyclophosphamide, cytarabine, etoposide in 125 patients whereas 3 subjects received cyclophosphamide and TBI (total body irridation. Bone marrow was stored for 72 hours in 4oC and re-infused 24 hours after conditioning completion. Bone marrow was a source of stem cells in 119 patients, peripheral blood in 2 and 7 subjects received both bone marrow and peripheral blood. Results. With a median follow-up after AHSCT of 1.6 years (range 0.1-22.3 years, the probability of leukemia-free survival (LFS for the whole group at 10 years was 27% and 23% at 20 years. Transplant-related mortality at 100 days after AHSCT was 3.2%.. There was a strong tendency for better LFS for MRD-negative patients if compared with patients who had positive or unknown MRD status at AHSCT (32% vs 23% and 25%, respectively; p=0.06. There was no difference in LFS between B- and T-lineage ALL as well as between patients transplanted in first complete remission (CR1 and CR2. LFS at 10 years for patients with detectable BCR-ABL at transplant was 20% and this was comparable with subjects with negative and missing BCR-ABL status (26% and 28%; p=0.97. Conclusions. The results of AHSCT for high-risk ALL remains unsatisfactory with low probability of long-term LFS.

  10. 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.

  11. 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

  12. Hepatitis C in Special Patient Cohorts: New Opportunities in Decompensated Liver Cirrhosis, End-Stage Renal Disease and Transplant Medicine

    Directory of Open Access Journals (Sweden)

    Anna Hüsing

    2015-08-01

    Full Text Available Worldwide, hepatitis C virus (HCV is a common infection. Due to new antiviral approaches and the approval of direct-acting antiviral agents (DAA, HCV therapy has become more comfortable. Nevertheless, there are special patient groups, in whom treatment of HCV is still challenging. Due to only few data available, tolerability and efficacy of DAAs in special patient cohorts still remain unclear. Such special patient cohorts comprise HCV in patients with decompensated liver disease (Child-Pugh Class B or C, patients with chronic kidney disease, and patients on waiting lists to renal/liver transplantation or those with HCV recurrence after liver transplantation. HCV infection in these patient cohorts has been shown to be associated with increased morbidity and mortality and may lead to reduced graft survival after transplantation. Successful eradication of HCV results in a better outcome concerning liver-related complications and in a better clinical outcome of these patients. In this review, we analyze available data and results from recently published literature and provide an overview of current recommendations of HCV-therapy regimen in these special patient cohorts.

  13. Hepatitis C in Special Patient Cohorts: New Opportunities in Decompensated Liver Cirrhosis, End-Stage Renal Disease and Transplant Medicine.

    Science.gov (United States)

    Hüsing, Anna; Kabar, Iyad; Schmidt, Hartmut H; Heinzow, Hauke S

    2015-01-01

    Worldwide, hepatitis C virus (HCV) is a common infection. Due to new antiviral approaches and the approval of direct-acting antiviral agents (DAA), HCV therapy has become more comfortable. Nevertheless, there are special patient groups, in whom treatment of HCV is still challenging. Due to only few data available, tolerability and efficacy of DAAs in special patient cohorts still remain unclear. Such special patient cohorts comprise HCV in patients with decompensated liver disease (Child-Pugh Class B or C), patients with chronic kidney disease, and patients on waiting lists to renal/liver transplantation or those with HCV recurrence after liver transplantation. HCV infection in these patient cohorts has been shown to be associated with increased morbidity and mortality and may lead to reduced graft survival after transplantation. Successful eradication of HCV results in a better outcome concerning liver-related complications and in a better clinical outcome of these patients. In this review, we analyze available data and results from recently published literature and provide an overview of current recommendations of HCV-therapy regimen in these special patient cohorts. PMID:26251895

  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 yellow peas led to lower BG compared with fibre (p pea components as value-added ingredients in foods designed to improve glycemic control. PMID:25302637

  16. 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.

  17. The analgesic efficacy of etoricoxib compared with oxycodone/acetaminophen in an acute postoperative pain model: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Chang, David J; Desjardins, Paul J; King, Thomas R; Erb, Tara; Geba, Gregory P

    2004-09-01

    Our objective in this study was to compare the analgesic effects of etoricoxib and oxycodone/acetaminophen in a postoperative dental pain model. Patients experiencing moderate to severe pain after extraction of two or more third molars were randomized to single doses of etoricoxib 120 mg (n = 100), oxycodone/acetaminophen 10/650 mg (n = 100), or placebo (n = 25). The primary end-point was total pain relief over 6 h. Other end-points included patient global assessment of response to therapy; onset, peak, and duration of effect; and rescue opioid analgesic use. Active treatments were statistically significantly superior to placebo for all efficacy measures. Total pain relief over 6 h for etoricoxib was significantly more than for oxycodone/acetaminophen (P acetaminophen by 5 min. The peak effect was similar for both drugs. Compared with oxycodone/acetaminophen patients, etoricoxib patients experienced a longer analgesic duration, had a smaller percentage requiring rescue opioids during 6 and 24 h, and required less rescue analgesia during 6 and 24 h. Oxycodone/acetaminophen treatment resulted in more frequent adverse events (AEs), drug-related AEs, nausea, and vomiting compared with etoricoxib treatment. In conclusion, etoricoxib 120 mg provided superior overall efficacy compared with oxycodone/acetaminophen 10/650 mg and was associated with significantly fewer AEs. PMID:15333415

  18. 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

  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. Study Design for the IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care) Trial: A Double-blind Randomized Controlled Trial of Intravenous Glucose, Insulin, and Potassium (GIK) for Acute Coronary Syndromes in Emergency Medical Services

    Science.gov (United States)

    Selker, Harry P.; Beshansky, Joni R.; Griffith, John L.; D’Agostino, Ralph B.; Massaro, Joseph M.; Udelson, James E.; Rashba, Eric J.; Ruthazer, Robin; Sheehan, Patricia R.; Desvigne-Nickens, Patrice; Rosenberg, Yves D.; Atkins, James M.; Sayah, Assaad J.; Aufderheide, Tom P.; Rackley, Charles E.; Opie, Lionel H.; Lambrew, Costas T.; Cobb, Leonard A.; MacLeod, Bruce A.; Ingwall, Joanne S.; Zalenski, Robert J.; Apstein, Carl S.

    2014-01-01

    Background Experimental studies suggest that metabolic myocardial support by intravenous (IV) glucose, insulin, and potassium (GIK) reduces ischemia-induced arrhythmias, cardiac arrest, mortality, progression from unstable angina pectoris (UAP) to acute myocardial infarction (AMI), and MI size. However, trials of hospital administration of IV GIK to patients with ST elevation MI (STEMI) have generally not shown favorable effects, possibly due to the GIK intervention taking place many hours after ischemic symptom onset. A trial of GIK used in the very first hours of ischemia has been needed, consistent with the timing of benefit seen in experimental studies. Objective The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care (IMMEDIATE) Trial tested whether, if given very early, GIK could have the impact seen in experimental studies. Accordingly, distinct from prior trials, IMMEDIATE tested the impact of GIK 1) in patients with acute coronary syndromes (ACS), rather than only AMI or STEMI, and 2) administered in prehospital emergency medical service (EMS) settings, rather than later, in hospitals, following emergency department evaluation. Design IMMEDIATE was an EMS-based randomized placebo-controlled clinical effectiveness trial conducted in 13 cities across the US which enrolled 911 participants. Eligible were patients age 30 or older for whom a paramedic performed a 12-lead electrocardiogram (ECG)to evaluate chest pain or other symptoms suggestive of ACS for whom electrocardiograph-based ACI-TIPI (acute cardiac ischemia time-insensitive predictive instrument) indicated a > 75% probability of ACS, and/or the TPI (thrombolytic predictive instrument) indicated presence of a STEMI, or if local criteria for STEMI notification of receiving hospitals were met. Prehospital IV GIK or placebo was started immediately. Pre-specified were the primary endpoint of progression of ACS to infarction, and as major secondary endpoints

  1. [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.

  2. 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

  3. 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.

  4. Effectiveness of a drinking-motive-tailored emergency-room intervention among adolescents admitted to hospital due to acute alcohol intoxication - A randomized controlled trial.

    Science.gov (United States)

    Wurdak, Mara; Wolstein, Jörg; Kuntsche, Emmanuel

    2016-06-01

    The aim of this study is to develop and test the effectiveness of a drinking-motive-tailored intervention for adolescents hospitalized due to alcohol intoxication in eight cities in Germany between December 2011 and May 2012 against a similar, non-motive-tailored intervention. In a randomized controlled trial, 254 adolescents received a psychosocial intervention plus motive-tailored (intervention group; IG) or general exercises (control group; CG). Adolescents in the IG received exercises in accordance with their drinking motives as indicated at baseline (e.g. alternative ways of spending leisure time or dealing with stress). Exercises for the CG contained alcohol-related information in general (e.g. legal issues). The data of 81 adolescents (age: M = 15.6, SD = 1.0; 42.0% female) who participated in both the baseline and the follow-up were compared using ANOVA with repeated measurements and effect sizes (available case analyses). Adolescents reported lower alcohol use at the four-week follow-up independently of the kind of intervention. Significant interaction effects between time and IG were found for girls in terms of drinking frequency (F = 7.770, p effect sizes of drinking frequency (d = - 1.18), binge drinking (d = - 1.61) and drunkenness (d = - 2.87) were much higher than the .8 threshold for large effects. Conducting psychosocial interventions in a motive-tailored way appears more effective for girls admitted to hospital due to alcohol intoxication than without motive-tailoring. Further research is required to address the specific needs of boys in such interventions. (German Clinical Trials Register, DRKS ID: DRKS00005588). PMID:26844193

  5. Randomized clinical trial on seven-day-per-week continuous accelerated irradiation for patients with esophageal carcinoma:Preliminary report on tumor response and acute toxicity

    Institute of Scientific and Technical Information of China (English)

    Su-Ping Sun; Ya-Zhou Liu; Tao Ye; Wen Zhang; Wen-Bin Shen; Jing-Lei Shi; Hai-Ting Xu; Wei-Dong Wang

    2006-01-01

    AIM: Tumor response and normal tissue toxicity of seven-day-per-week continuous accelerated irradiation (CAIR) for patients with esophageal carcinoma were evaluated and compared to conventional irradiation (CR).METHODS: Sixty patients with squamous cell carcinoma of the esophagus were randomized into two groups:the CAIR group (30 patients) and the CR group (30 pa(RT) with 2 Gy/fraction per day at 7 d/wk with a total dose of 50-70 Gy (average dose 64.2 Gy). The overall time of irradiation was 3.6-5.0 wk (average 4.6 wk). RT in the CR group was 2 Gy/fraction per day at 5 d/wk with a total dose of 40-70 Gy (average dose 61.7 Gy).The overall time of irradiation was 4.0-7.0 wk (average 6.4wk).RESULTS: The data showed that the immediate tumor response to RT was better in the CAIR group than in the CR group. Efficiency rates (CR plus PR) were 82.8%(24/29) and 58.6% (17/29), respectively (P = 0.047). In both groups the incidences of esophagitis and tracheitis were insignificant (P = 0.376, 0.959), and no patient received toxicity that could not be tolerated.CONCLUSION: CAIR shortens overall treatment time and is well tolerated by patients. It may be superior to CR in enhancing the local response of tumor, but its remote effect for esophageal carcinoma awaits further follow-up.

  6. Effects of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life: A randomized controlled trial in prostate cancer patients undergoing radiotherapy

    International Nuclear Information System (INIS)

    Purpose: To study the effect of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life (HRQOL) in prostate cancer patients referred to radiotherapy. Materials and methods: A total of 130 patients were randomly assigned to one of two groups: an intervention group (IG, n = 64), instructed to reduce their intake of insoluble dietary fibres and lactose, a standard care group (SC, n = 66), instructed to continue their normal diet. Gastrointestinal side effects and other aspects of HRQOL were evaluated from baseline up to 2 months after completed radiotherapy, using the EORTC QLQ-C30 and QLQ-PR25 and the study-specific Gastrointestinal Side Effects Questionnaire (GISEQ). A scale indicating adherence to dietary instructions was developed from a Food Frequency Questionnaire (FFQ), with lower scores representing better compliance. Descriptive and inferential statistical analyses were conducted. Results: There was an interaction effect between randomization and time in the FFQ Scores (p < 0.001), indicating that both groups followed their assigned dietary instructions. The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. During radiotherapy, the percentage of patients with bowel symptoms and bloated abdomen was lower in IG compared to SC, but the between-group differences were not statistically significant. During radiotherapy, the percentage of patients with bowel symptoms, urinary symptoms, pain, fatigue and diminished physical and role functioning increased in both groups. Conclusions: The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. The tendency towards lower prevalence of bowel symptoms in IG may indicate some positive effect of the dietary intervention, but methodological refinements, clearer results and longer follow-up are needed before the value of diet change can be established with certainty.

  7. 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.

  8. Random Walks on Random Graphs

    Science.gov (United States)

    Cooper, Colin; Frieze, Alan

    The aim of this article is to discuss some of the notions and applications of random walks on finite graphs, especially as they apply to random graphs. In this section we give some basic definitions, in Section 2 we review applications of random walks in computer science, and in Section 3 we focus on walks in random graphs.

  9. Acute Bronchitis

    Science.gov (United States)

    ... of bronchitis: acute and chronic. Most cases of acute bronchitis get better within several days. But your cough ... that cause colds and the flu often cause acute bronchitis. These viruses spread through the air when people ...

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. Effectiveness evaluation of an integrated automatic termomechanic massage system (SMATH® system in non-specific sub-acute and chronic low back pain - a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial

    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

  16. Energy randomness

    OpenAIRE

    Miller, Joseph S.; Rute, Jason

    2015-01-01

    Energy randomness is a notion of partial randomness introduced by Diamondstone and Kjos-Hanssen to characterize the sequences that can be elements of a Martin-L\\"of random closed set (in the sense of Barmpalias, Brodhead, Cenzer, Dashti, and Weber). It has also been applied by Allen, Bienvenu, and Slaman to the characterization of the possible zero times of a Martin-L\\"of random Brownian motion. In this paper, we show that $X \\in 2^\\omega$ is $s$-energy random if and only if $\\sum_{n\\in\\omega...

  17. Randomized random walk on a random walk

    International Nuclear Information System (INIS)

    This paper discusses generalizations of the model introduced by Kehr and Kunter of the random walk of a particle on a one-dimensional chain which in turn has been constructed by a random walk procedure. The superimposed random walk is randomised in time according to the occurrences of a stochastic point process. The probability of finding the particle in a particular position at a certain instant is obtained explicitly in the transform domain. It is found that the asymptotic behaviour for large time of the mean-square displacement of the particle depends critically on the assumed structure of the basic random walk, giving a diffusion-like term for an asymmetric walk or a square root law if the walk is symmetric. Many results are obtained in closed form for the Poisson process case, and these agree with those given previously by Kehr and Kunter. (author)

  18. [Treatment of acute myocardial infarction with betareceptor blocking agents. I. Hemodynamic effects of Propranolol in combination with digitalis (author's transl)].

    Science.gov (United States)

    Oeff, M; Lehmann, H U; Witt, E; Hochrein, H

    1981-06-01

    In the acute stage of transmural myocardial infarction, 22 patients ranging in age from 34 to 76 (mean 61.6) were given propranolol- because of its alleged myocardium-protecting properties - intravenously at a dosage of 0.03 to 0.1 mg/kg body weight under conditions of continuous hemodynamic control. Subsequently, the influence of digoxin, administered i. v. at a dosage of 0.01 my/kg body weight, on the negative-inotropic propranolol effects was examined. A hemodynamic comparison was made of the effects of propranolol before and after digitalis administration. In patients with compensated cardiac function (group 1, 16 patients), the propranolol-induced drop in the left ventricular stroke-work-index and rise in the left-ventricular filling pressure was completely compensated again by digitalis. The frequency-decreasing propranolol effect was nor influenced by digitalis. In patients with cardiac decompensation (group 2, 6 patients) digitalis only led to a renewed compensation of the left-ventricular stroke-work-index, the rise of the left-ventricular filling pressure remained unaffected. It follows from that, in cases of myocardial infarction without cardial decompensation, propranolol requires concomitant digitalisation. In cases of already existent myocardial insufficiency, propranolol can produce an unfavorable increase of the decompensation signs. PMID:7257499

  19. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study.

    Science.gov (United States)

    Povsic, Thomas J; Roe, Matthew T; Ohman, Erik Magnus; Steg, Philippe Gabriel; James, Stefan; Plotnikov, Alexei; Mundl, Hardi; Welsh, Robert; Bode, Christoph; Gibson, Charles Michael

    2016-04-01

    Dual antiplatelet therapy (DAPT), the combination of aspirin and a P2Y12 inhibitor, given for 12 months remains the standard of care after presentation with acute coronary syndrome (ACS) because it has been shown to be associated with a significant reduction in ischemic events compared with aspirin monotherapy. The factor Xa inhibitor rivaroxaban was shown to be associated with a significant reduction in the composite of cardiovascular death, myocardial infarction, and stroke, and resulted in a nominal reduction in cardiovascular death, when added to background DAPT in the ATLAS ACS 2-TIMI 51 trial; however, there was excessive bleeding with this "triple-therapy" approach. The combination of rivaroxaban with P2Y12 inhibition in a "dual-pathway" approach may be an effective therapeutic regimen for the treatment of ACS, given the known importance of P2Y12 inhibition after stenting and intriguing data that the combination of an anticoagulant with clopidogrel after stenting in patients with atrial fibrillation appears an attractive option to this patient population. GEMINI-ACS-1 is a prospective, randomized, double-dummy, double-blind, active-controlled trial that will assess the safety of dual antithrombotic therapy (rivaroxaban [2.5 mg twice daily] + P2Y12 inhibitor) as compared with DAPT (aspirin [100 mg] + P2Y12 inhibitor) within 10 days of an ACS event in 3,000 patients. Patients will be randomized in a 1:1 ratio stratified by intended P2Y12 inhibitor use (clopidogrel 75 mg daily or ticagrelor 90 mg twice daily), with 1500 patients expected in each P2Y12 inhibitor strata. The primary end point is Thrombolysis in Myocardial Infarction clinically significant bleeding (major, minor, or requiring medical attention). The exploratory efficacy determination will be a composite of cardiovascular death, myocardial infarction, ischemic stroke, and stent thrombosis. GEMINI-ACS-1 will assess the safety and feasibility of dual antithrombotic therapy with rivaroxaban and a P2Y

  20. 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

  1. 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

  2. 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

  3. 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. PMID:27261170

  4. Impact of aerobic exercise training during chemotherapy on cancer related cognitive impairments in patients suffering from acute myeloid leukemia or myelodysplastic syndrome - Study protocol of a randomized placebo-controlled trial.

    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.

  5. 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.

  6. [The significance of morphologic changes in acute occlusive cholecystitis for determining the surgical approach].

    Science.gov (United States)

    Iukhtin, V I; Khripun, A I; Raksha, A P; Zhukotskiĭ, A V; Sergeeva, N A; Dorofeeva, I M; Belous, G G

    1996-01-01

    Specific morphological and functional changes in the liver in acute obturative cholecystitis have been experimentally studied in 30 dogs and clinically examined in 21 patients. No morphological substrate of liver insufficiency were found in early period of acute obturative cholecystitis. Early changes in the liver are of reactive nature and have the features of active nonspecific hepatitis. The reactions of compensation and decompensation are changing each other periodically. The intensive reactions of compensation take place in the first 2 or 3 days of disease. The reactions of compensation weaken gradually. There is no correlation between changes in the liver and in blood serum. The early surgery and laparoscopic procedures in acute obturative cholecystitis are advocated. PMID:8965448

  7. Acute Pancreatitis and Pregnancy

    Science.gov (United States)

    ... Acute Pancreatitis > Acute Pancreatitis and Pregnancy test Acute Pancreatitis and Pregnancy Timothy Gardner, MD Acute pancreatitis is ... of acute pancreatitis in pregnancy. Reasons for Acute Pancreatitis and Pregnancy While acute pancreatitis is responsible for ...

  8. 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.

  9. What Is Decompensated Cirrhosis?

    Science.gov (United States)

    ... Z) Hepatitis HIV Mental Health Mental Health Home Suicide Prevention Substance Abuse Military Sexual Trauma PTSD Research (MIRECC) Military Exposures Polytrauma Rehabilitation Spinal Cord Injury Telehealth Womens Health Issues Wellness Programs MyHealtheVet Nutrition Quitting Smoking ...

  10. Acute fatal metabolic complications in alkaptonuria.

    Science.gov (United States)

    Davison, A S; Milan, A M; Gallagher, J A; Ranganath, L R

    2016-03-01

    Alkaptonuria (AKU) is a rare inherited metabolic disorder of tyrosine metabolism that results from a defect in an enzyme called homogentisate 1,2-dioxygenase. The result of this is that homogentisic acid (HGA) accumulates in the body. HGA is central to the pathophysiology of this disease and the consequences observed; these include spondyloarthropathy, rupture of ligaments/muscle/tendons, valvular heart disease including aortic stenosis and renal stones. While AKU is considered to be a chronic progressive disorder, it is clear from published case reports that fatal acute metabolic complications can also occur. These include oxidative haemolysis and methaemoglobinaemia. The exact mechanisms underlying the latter are not clear, but it is proposed that disordered metabolism within the red blood cell is responsible for favouring a pro-oxidant environment that leads to the life threatening complications observed. Herein the role of red blood cell in maintaining the redox state of the body is reviewed in the context of AKU. In addition previously reported therapeutic strategies are discussed, specifically with respect to why reported treatments had little therapeutic effect. The potential use of nitisinone for the management of patients suffering from the acute metabolic decompensation in AKU is proposed as an alternative strategy. PMID:26596578

  11. Bronchitis - acute

    Science.gov (United States)

    ... sharing features on this page, please enable JavaScript. Acute bronchitis is swelling and inflammation in the main passages ... present only for a short time. Causes When acute bronchitis occurs, it almost always comes after having a ...

  12. Acute pancreatitis

    OpenAIRE

    Bo-Guang Fan; Åke Andrén-Sandberg

    2010-01-01

    Background : Acute pancreatitis continues to be a serious illness, and the patients with acute pancreatitis are at risk to develop different complications from ongoing pancreatic inflammation. Aims : The present review is to highlight the classification, treatment and prognosis of acute pancreatitis. Material & Methods : We reviewed the English-language literature (Medline) addressing pancreatitis. Results : Acute pancreatitis is frequently caused by gallstone disease or excess alcohol ingest...

  13. Acute pancreatitis

    OpenAIRE

    Bo-Guang Fan; Åke Andrén-Sandberg

    2010-01-01

    Background: Acute pancreatitis continues to be a serious illness, and the patients with acute pancreatitis are at risk to develop different complications from ongoing pancreatic inflammation. Aims: The present review is to highlight the classification, treatment and prognosis of acute pancreatitis. Material & Methods: We reviewed the English-language literature (Medline) addressing pancreatitis. Results: Acute pancreatitis is frequently caused by gallstone disease or excess alcohol ingestion....

  14. 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

  15. 急性失代偿性心力衰竭的现代观点(六)%Modern Concepts of Acute Decompensated Heart Failure(ADHF)(6)

    Institute of Scientific and Technical Information of China (English)

    钱方毅

    2009-01-01

    @@ 6.4.2 血管加压素拮抗剂血 管加压素拮抗剂(vasopressin antagonist,AVP拮抗剂)AVP(或抗利尿激素)由垂体后叶所释放,是对一些刺激因素的反应,包括血浆渗透压的增高,严重低血容量、低血压及Ang Ⅱ.已经鉴定出有两型AVP受体:V1(V1a,V1b)及V2受体.V1a受体存在于血管壁,介导血管收缩.V2受体则位于肾脏,可促进水的重吸收.在急性及慢性HF时,AVP的水平均不正常.

  16. 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.

  17. 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

  18. 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.

    Directory of Open Access Journals (Sweden)

    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.

  19. 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.

  20. 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.

  1. A Randomized Study of Clofarabine Versus Clofarabine Plus Low-Dose Cytarabine us Front-Line Therapy for Older Patients with Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome%氯法拉滨与氯法拉滨联合小剂量阿糖胞苷对老年急性髓性白血病及高危骨髓增生异常综合征随机对照研究

    Institute of Scientific and Technical Information of China (English)

    肖志坚; 陆泽生

    2009-01-01

    @@ 1 文献来源 Faded S, Ravandi F, Huang X, et al. A randomized study of Clofarabine versus Clofarabine plus low-dose Cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome [J]. Blood, 2008,112(5) : 1638-1645.

  2. 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)....

  3. 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...

  4. 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.

  5. Random magnetism

    International Nuclear Information System (INIS)

    The 'ingredients' which control a phase transition in well defined systems as well as in random ones (e.q. random magnetic systems) are listed and discussed within a somehow unifying perspective. Among these 'ingredients' the couplings and elements responsible for the cooperative phenomenon, the topological connectivity as well as possible topological incompatibilities, the influence of new degrees of freedom, the order parameter dimensionality, the ground state degeneracy and finally the 'quanticity' of the system are found. The general trends, though illustrated in magnetic systems, essentially hold for all phase transitions, and give a basis for connection of this area with Field theory, Theory of dynamical systems, etc. (Author)

  6. Treatment disparities in acute coronary syndromes, heart failure, and kidney disease.

    Science.gov (United States)

    McCullough, Peter A; Maynard, Robert C

    2011-01-01

    It has been consistently observed that patients with renal dysfunction have more premature, severe, complicated, and fatal cardiovascular disease than age- and sex-matched individuals with normal renal function. There have been 4 major explanations for this finding: (1) positive confounding by third variables associated with chronic kidney disease (CKD), including diabetes mellitus and hypertension; (2) therapeutic nihilism or lesser use of beneficial therapies in CKD; (3) greater toxicities of therapies, such as bleeding from anticoagulants or contrast-induced kidney injury; (4) biological factors which result directly from CKD that work to promote and accelerate cardiovascular disease. In this paper, we focus on the issue of treatment disparities or therapeutic nihilism and its contribution to poor outcomes in the setting of acute coronary syndromes and acutely decompensated heart failure. This issue is important because if we can overcome barriers to the utilization of beneficial treatments, then clinical outcomes should improve over time. PMID:21625092

  7. Random dynamics

    International Nuclear Information System (INIS)

    The goal of random dynamics is the derivation of the laws of Nature as we know them (standard model) from inessential assumptions. The inessential assumptions made here are expressed as sets of general models at extremely high energies: gauge glass and spacetime foam. Both sets of models lead tentatively to the standard model. (orig.)

  8. 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.

  9. Random Decrement

    DEFF Research Database (Denmark)

    Asmussen, J.C.; Ibrahim, S.R.; Brincker, Rune

    Abstraet Thispaper demansirates how to use the Random Decrement (RD) technique for identification o flinear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a...

  10. Random Decrement

    DEFF Research Database (Denmark)

    Asmussen, J. C.; Ibrahim, S. R.; Brincker, Rune

    This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

  11. Random Decrement

    DEFF Research Database (Denmark)

    Asmussen, J. C.; Ibrahim, R.; Brincker, Rune

    1998-01-01

    This paper demonstrates how to use the Random Decrement (RD) technique for identification of linear structures subjected to ambient excitation. The theory behind the technique will be presented and guidelines how to choose the different variables will be given. This is done by introducing a new...

  12. 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

  13. Chinese herbal medicine for severe acute respiratory syndrome

    DEFF Research Database (Denmark)

    Liu, Jianping; Manheimer, Eric; Shi, Yi;

    2004-01-01

    To review randomized controlled trials (RCTs) evaluating the effects of Chinese herbal medicine for treating severe acute respiratory syndrome (SARS) systematically.......To review randomized controlled trials (RCTs) evaluating the effects of Chinese herbal medicine for treating severe acute respiratory syndrome (SARS) systematically....

  14. RANDOM LASSO.

    Science.gov (United States)

    Wang, Sijian; Nan, Bin; Rosset, Saharon; Zhu, Ji

    2011-03-01

    We propose a computationally intensive method, the random lasso method, for variable selection in linear models. The method consists of two major steps. In step 1, the lasso method is applied to many bootstrap samples, each using a set of randomly selected covariates. A measure of importance is yielded from this step for each covariate. In step 2, a similar procedure to the first step is implemented with the exception that for each bootstrap sample, a subset of covariates is randomly selected with unequal selection probabilities determined by the covariates' importance. Adaptive lasso may be used in the second step with weights determined by the importance measures. The final set of covariates and their coefficients are determined by averaging bootstrap results obtained from step 2. The proposed method alleviates some of the limitations of lasso, elastic-net and related methods noted especially in the context of microarray data analysis: it tends to remove highly correlated variables altogether or select them all, and maintains maximal flexibility in estimating their coefficients, particularly with different signs; the number of selected variables is no longer limited by the sample size; and the resulting prediction accuracy is competitive or superior compared to the alternatives. We illustrate the proposed method by extensive simulation studies. The proposed method is also applied to a Glioblastoma microarray data analysis. PMID:22997542

  15. Fractional randomness

    Science.gov (United States)

    Tapiero, Charles S.; Vallois, Pierre

    2016-11-01

    The premise of this paper is that a fractional probability distribution is based on fractional operators and the fractional (Hurst) index used that alters the classical setting of random variables. For example, a random variable defined by its density function might not have a fractional density function defined in its conventional sense. Practically, it implies that a distribution's granularity defined by a fractional kernel may have properties that differ due to the fractional index used and the fractional calculus applied to define it. The purpose of this paper is to consider an application of fractional calculus to define the fractional density function of a random variable. In addition, we provide and prove a number of results, defining the functional forms of these distributions as well as their existence. In particular, we define fractional probability distributions for increasing and decreasing functions that are right continuous. Examples are used to motivate the usefulness of a statistical approach to fractional calculus and its application to economic and financial problems. In conclusion, this paper is a preliminary attempt to construct statistical fractional models. Due to the breadth and the extent of such problems, this paper may be considered as an initial attempt to do so.

  16. Acute-on-chronic liver failure: a review

    Directory of Open Access Journals (Sweden)

    Zamora Nava LE

    2014-04-01

    Full Text Available Luis Eduardo Zamora Nava,1 Jonathan Aguirre Valadez,2 Norberto C Chávez-Tapia,3 Aldo Torre21Department of Endoscopy, 2Department of Gastroenterology, National Institute of Medical Sciences and Nutrition Salvador Zubirán, 3Obesity and Digestive Diseases Unit, Medica Sur Clinic and Foundation, Mexico City, MexicoAbstract: There is no universally accepted definition of acute-on-chronic liver failure; however, it is recognized as an entity characterized by decompensation from an underlying chronic liver disease associated with organ failure that conveys high short-term mortality, with alcoholism and infection being the most frequent precipitating events. The pathophysiology involves inflammatory processes associated with a trigger factor in susceptible individuals (related to altered immunity in the cirrhotic population. This review addresses the different definitions developed by leading research groups, epidemiological and pathophysiological aspects, and the latest treatments for this entity.Keywords: acute-on-chronic liver failure, cirrhosis, organ failure, acute kidney injury, infection

  17. Including whey protein and whey permeate in ready-to-use supplementary food improves recovery rates in children with moderate acute malnutrition: A randomized, double-blind clinical trial

    Science.gov (United States)

    The utility of dairy ingredients in the supplementary foods used in the treatment of childhood moderate acute malnutrition (MAM) remains unsettled. We evaluated the effectiveness of a peanut-based ready-to-use supplementary food (RUSF) with soy protein compared with a novel RUSF containing dairy in...

  18. 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

    OpenAIRE

    Persell, Stephen D.; Friedberg, Mark W.; Meeker, Daniella; Linder, Jeffrey A; Craig R. Fox; Goldstein, Noah J.; Shah, Parth D; Knight, Tara K; Doctor, Jason N

    2013-01-01

    Abstract 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 th...

  19. Characteristics, Diagnosis and Prognosis of Acute-on-Chronic Liver Failure in Cirrhosis Associated to Hepatitis B.

    Science.gov (United States)

    Li, Hai; Chen, Liu-Ying; Zhang, Nan-Nan; Li, Shu-Ting; Zeng, Bo; Pavesi, Marco; Amorós, Àlex; Mookerjee, Rajeshwar P; Xia, Qian; Xue, Feng; Ma, Xiong; Hua, Jing; Sheng, Li; Qiu, De-Kai; Xie, Qing; Foster, Graham R; Dusheiko, Geoffrey; Moreau, Richard; Gines, Pere; Arroyo, Vicente; Jalan, Rajiv

    2016-01-01

    The diagnostic and prognostic criteria of acute-on-chronic liver failure (ACLF) were developed in patients with no Hepatitis B virus (HBV) cirrhosis (CANONIC study). The aims of this study were to evaluate whether the diagnostic (CLIF-C organ failure score; CLIF-C OFs) criteria can be used to classify patients; and the prognostic score (CLIF-C ACLF score) could be used to provide prognostic information in HBV cirrhotic patients with ACLF. 890 HBV associated cirrhotic patients with acute decompensation (AD) were enrolled. Using the CLIF-C OFs, 33.7% (300 patients) were diagnosed as ACLF. ACLF was more common in the younger patients and in those with no previous history of decompensation. The most common organ failures were 'hepatic' and 'coagulation'. As in the CANONIC study, 90-day mortality was extremely low in the non-ACLF patients compared with ACLF patients (4.6% vs 50%, p < 0.0001). ACLF grade and white cell count, were independent predictors of mortality. CLIF-C ACLFs accurately predicted short-term mortality, significantly better than the MELDs and a disease specific score generated for the HBV patients. Current study indicates that ACLF is a clinically and pathophysiology distinct even in HBV patients. Consequently, diagnostic criteria, prognostic scores and probably the management of ACLF should base on similar principles. PMID:27146801

  20. To Observe the Effect of Low-dose Peginterferon α-2a and Ribavirin Treatment of Decompensated Hepatitis C Cirrhosis%小剂量聚乙二醇干扰素α-2a联合利巴韦林抗病毒治疗失代偿期丙型肝炎肝硬化的临床效果观察

    Institute of Scientific and Technical Information of China (English)

    王琳; 王智敏

    2015-01-01

    Objective To study the patients with cirrhosis of the liver decompensation period of hepatitis c, observe choice interferon alpha 2 a small dose of polyethylene glycol (Peg-interferons alpha 2 a) and ribavirin completed after treatment for clinical treatment. Methods 70 patients with hepatitis c cirrhosis of the liver decompensation period from January 2013 to January 2015. Through the stochastic indicator method complete hepatitis cirrhosis patients randomized, C2 group of 35 cases (control group) : clinical choose the method of conventional treatment, C1 group (observation group of 35 cases):clinical choose Peg-interferons alpha-2 a plus ribavirin treatment method. Compared to two kinds of hepatitis, liver cirrhosis patients in such aspects as clinically relevant indicators show the difference. Results Two groups of patients with cirrhosis of the liver decompensation period of hepatitis c after completion of clinical treatment in ALT, propagated and AST, C1 group is obviously better than the group of C2 hepatitis cirrhosis patients (P<0.05). In terms of liver ifbrosis indexes, C1 group is obviously better than the group of C2 hepatitis cirrhosis patients (P<0.05). Conclusion For patients with cirrhosis of the liver decompensation period of hepatitis c, clinical choose Peg-interferons alpha 2 a and method of ribavirin treatment, can effectively improve liver ifbrosis indexes such as, in patients with signiifcantly alleviate the clinical symptoms of patients with hepatitis cirrhosis of the liver, will eventually decompensation period of hepatitis c effective to improve the quality of life of patients with cirrhosis.%目的:探讨针对失代偿期丙型肝炎肝硬化患者,观察选择小剂量聚乙二醇干扰素α-2a(Peg-IFNα-2a)+利巴韦林完成治疗后获得的临床治疗。方法选择我院2013年1月~2015年1月失代偿期丙型肝炎肝硬化患者70例。通过随机数表法完成肝炎肝硬化患者的随机分组,C1组(观察组35

  1. Acute dyspnea

    International Nuclear Information System (INIS)

    Radiodiagnosis is applied to determine the causes of acute dyspnea. Acute dyspnea is shown to aggravate the course of pulmonary diseases (bronchial asthma, obstructive bronchitis, pulmonary edema, throboembolism of pulmonary arteries etc) and cardiovascular diseases (desiseas of myocardium). The main tasks of radiodiagnosis are to determine volume and state of the lungs, localization and type of pulmonary injuries, to verify heart disease and to reveal concomitant complications

  2. Random tensors

    CERN Document Server

    Gurau, Razvan

    2017-01-01

    Written by the creator of the modern theory of random tensors, this book is the first self-contained introductory text to this rapidly developing theory. Starting from notions familiar to the average researcher or PhD student in mathematical or theoretical physics, the book presents in detail the theory and its applications to physics. The recent detections of the Higgs boson at the LHC and gravitational waves at LIGO mark new milestones in Physics confirming long standing predictions of Quantum Field Theory and General Relativity. These two experimental results only reinforce today the need to find an underlying common framework of the two: the elusive theory of Quantum Gravity. Over the past thirty years, several alternatives have been proposed as theories of Quantum Gravity, chief among them String Theory. While these theories are yet to be tested experimentally, key lessons have already been learned. Whatever the theory of Quantum Gravity may be, it must incorporate random geometry in one form or another....

  3. 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

    OpenAIRE

    Lenka Belinova; Hana Kahleova; Hana Malinska; Ondrej Topolcan; Jindra Vrzalova; Olena Oliyarnyk; Ludmila Kazdova; Martin Hill; Terezie Pelikanova

    2014-01-01

    Background The intake of meat, particularly processed meat, is a dietary risk factor for diabetes. Meat intake impairs insulin sensitivity and leads to increased oxidative stress. However, its effect on postprandial gastrointestinal hormone (GIH) secretion is unclear. We aimed to investigate the acute effects of two standardized isocaloric meals: a processed hamburger meat meal rich in protein and saturated fat (M-meal) and a vegan meal rich in carbohydrates (V-meal). We hypothesized that the...

  4. Improving the treatment of severe acute malnutrition in childhood: a randomized controlled trial of synbiotic-enhanced therapeutic food with long term follow-up of post-treatment mortality and morbidity

    OpenAIRE

    Kerac, M

    2011-01-01

    BACKGROUND: Tackling severe acute malnutrition (SAM) is a global public health priority. This thesis explores two major influences on treatment outcomes: -Treatment efficacy -Patient-related risk factors OBJECTIVES: 1. To explore whether a pre/probiotic mixture (Synbiotic2000 Forte™) improves treatment outcomes (nutritional and clinical) in children affected by SAM. 2. To describe long term outcomes from SAM and identify key mortality risk factors. METHODS: All 1024 malno...

  5. Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial

    OpenAIRE

    Meister, Rebecca; Princip, Mary; Schmid, Jean-Paul; Schnyder, Ulrich; Barth, Jürgen; Znoj, Hansjörg; Herbert, Claudia; von Känel, Roland

    2013-01-01

    BACKGROUND Posttraumatic Stress Disorder (PTSD) may occur in patients after exposure to a life-threatening illness. About one out of six patients develop clinically relevant levels of PTSD symptoms after acute myocardial infarction (MI). Symptoms of PTSD are associated with impaired quality of life and increase the risk of recurrent cardiovascular events. The main hypothesis of the MI-SPRINT study is that trauma-focused psychological counseling is more effective than non-trauma focused co...

  6. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome : The design of the GEMINI-ACS-1 phase II study

    OpenAIRE

    Povsic, Thomas J.; Roe, Matthew T.; Ohman, Erik Magnus; Steg, Philippe Gabriel; James, Stefan; Plotnikov, Alexei; Mundl, Hardi; Welsh, Robert; Bode, Christoph; Gibson, Charles Michael

    2016-01-01

    Dual antiplatelet therapy (DAPT), the combination of aspirin and a P2Y12 inhibitor, given for 12 months remains the standard of care after presentation with acute coronary syndrome (ACS) because it has been shown to be associated with a significant reduction in ischemic events compared with aspirin monotherapy. The factor Xa inhibitor rivaroxaban was shown to be associated with a significant reduction in the composite of cardiovascular death, myocardial infarction, and stroke, and resulted in...

  7. Acute myelogenous leukemia (AML) - children

    Science.gov (United States)

    Acute myelogenous leukemia - children; AML; Acute myeloid leukemia - children; Acute granulocytic leukemia - children; Acute myeloblastic leukemia - children; Acute non-lymphocytic leukemia (ANLL) - children

  8. Random functions and turbulence

    CERN Document Server

    Panchev, S

    1971-01-01

    International Series of Monographs in Natural Philosophy, Volume 32: Random Functions and Turbulence focuses on the use of random functions as mathematical methods. The manuscript first offers information on the elements of the theory of random functions. Topics include determination of statistical moments by characteristic functions; functional transformations of random variables; multidimensional random variables with spherical symmetry; and random variables and distribution functions. The book then discusses random processes and random fields, including stationarity and ergodicity of random

  9. Randomized clinical trial of laparoscopic versus open appendicectomy

    DEFF Research Database (Denmark)

    Pedersen, Allan Gorm; Petersen, O B; Wara, P;

    2001-01-01

    BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...

  10. [Pregnancy and acute ischemic stroke].

    Science.gov (United States)

    Bereczki, Dániel

    2016-05-15

    Pregnancy-related ischemic strokes play an important role in both maternal and fetal morbidity and mortality. Changes in hemostaseology and hemodynamics as well as risk factors related to or independent from pregnancy contribute to the increased stroke-risk during gestation and the puerperium. Potential teratogenic effects make diagnostics, acute therapy and prevention challenging. Because randomized, controlled trials are not available, a multicenter registry of patients with gestational stroke would be desirable. Until definite guidelines emerge, management of acute ischemic stroke during pregnancy remains individual, involving experts and weighing the risks and benefits.

  11. Analysis of prognostic factors and establishment of prognostic index for patients with decompensated cirhosis%失代偿期肝硬化患者预后因素分析及预后指数建立

    Institute of Scientific and Technical Information of China (English)

    张玉; 刘志坚; 周贤斌

    2011-01-01

    Objective To analyze prognostic factors and to establish prognostic index for the patients with decompensated cirrhosis.Methods The clinical data were collected from 196 patients with decompensated cirrhosis admitted to hospital from January 2004 to December 2006.Prognostic factors of decompensated cirrhosis were selected by Cox's proportional hazard regression model and prognostic index (PI) was established.The accuracy of PI, the Child- Turcotte- Pugh (CTP) score and model for end stage liver disease (MELD) in prognosis of decompensated cirrhosis was evaluated by ROC curve.Results Six prognostic factors were extracted by Cox's proportional hazard regression model: ascites levels, grading of hepatic encephalopathy, upper gastrointestinal bleeding, A/G, INR and serum creatinine.The area under ROC curve of PI, CTP and MELD was 0.840,0.745,0.780 respectively in predicting 1 year prognosis of decompensated cirrhosis.Conclusion Six risk factors are associated with prognosis of decompensated cirrhosis.The prognostic index established in this study is superior to CTP and MELD in short and medium term prognosis for decompensated cirrhosis.%目的 分析失代偿期肝硬化患者预后的影响因素,尝试建立预后判断指数(PI指数),以判断肝功能衰竭的预后. 方法应用Cox比例风险回归模型筛选196例失代偿期肝硬化患者预后的危险因素;应用ROC曲线下面积来评估PI指数、CTP分级、MELD模型对失代偿期肝硬化患者预后预测的准确性和精确性. 结果⑴筛选出6个影响失代偿期肝硬化患者1年预后的独立危险因素:腹水程度、肝性脑病分期、上消化道出血、A/G比值、INR、肌酐.⑵预测失代偿期肝硬化患者1年预后时,PI指数、CTP分级及MELD模型的ROC曲线下面积分别为分别为0.840、0.745、0.780. 结论腹水程度、肝性脑病分期、上消化道出血、A/G比值、INR、肌酐是影响失代偿期肝硬化患者预后的6个独立危险因素;PI指

  12. Efficacy analysis of Dahuang Fuzi Decotion on treating severe acute pancreatitis in patients with ARDS

    Institute of Scientific and Technical Information of China (English)

    吕春雨

    2013-01-01

    Objective To observe the the therapeutic efficacy of Dahuang Fuzi Decoction in patients with acute respiratory distress syndrome(ARDS)and severe acute pancreatitis(SAP).Methods A prospective,multi-center,randomized

  13. A prospect, random, single blind and control study on recovered effect of sermior treatment on motor function of patients with acute cerebral infarction%脑通对急性脑梗死患者运动功能的康复意义:前瞻性、随机、单盲对照研究

    Institute of Scientific and Technical Information of China (English)

    郑衍平; 何明利

    2002-01-01

    Objective To evaluate recovered effect of sermior treatment on motor function of patients with acute cerebral infarction. Methods Prospect, random, single blind and control study on sermior, citicoline and cerebrolysin, using volume of low dense in CT (CTV), glutamate content in cerebral spinal fluid (CSF) and total fraction of Fugl Meyer motor function score as evaluating index to study inpatient patients. Result Decrease of CTV and glutamate content in CSF and increase of total fraction of Fugl Meyer motor function score in sermior treatment group, in citicoline treatment group, in sermior and cerebrolysin treatment group were significant compared with those of citicoline treatment group, cerebrolysin treatment group (P< 0.05). Conclusion Unite long term sermior therapy can decrease cerebral infarction volume and improve synthesize motor function apparently.

  14. Orange juice–derived flavanone and phenolic metabolites do not acutely affect cardiovascular risk biomarkers: a randomized, placebo-controlled, crossover trial in men at moderate risk of cardiovascular disease

    OpenAIRE

    Schar, Manuel; Curtis, Peter; Hazim, Sara; Ostertag, Luisa; Kay, Colin; Potter, John; Cassidy, Aedin

    2015-01-01

    Background: Epidemiologic data suggest inverse associations between citrus flavanone intake and cardiovascular disease (CVD) risk. However, insufficient randomized controlled trial data limit our understanding of the mechanisms by which flavanones and their metabolites potentially reduce cardiovascular risk factors. Objective: We examined the effects of orange juice or a dose-matched hesperidin supplement on plasma concentrations of established and novel flavanone metabolites and their effect...

  15. A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome

    OpenAIRE

    Faderl, Stefan; Ravandi, Farhad; Huang, Xuelin; Garcia-Manero, Guillermo; Ferrajoli, Alessandra; Estrov, Zeev; Borthakur, Gautam; Verstovsek, Srdan; Thomas, Deborah A.; Kwari, Monica; Kantarjian, Hagop M.

    2008-01-01

    We previously reported the feasibility of clofarabine and cytarabine combinations in AML. Questions remain as to (1) the therapeutic advantage of this combination and (2) the role of lower doses of clofarabine and cytarabine in older patients. We have conducted an adaptively randomized study of lower-dose clofarabine with or without low-dose cytarabine in previously untreated patients with AML aged 60 years and older. Patients received 30 mg/m2 clofarabine intravenously daily for 5 days with ...

  16. Random fixed points and random differential inclusions

    Directory of Open Access Journals (Sweden)

    Nikolaos S. Papageorgiou

    1988-01-01

    Full Text Available In this paper, first, we study random best approximations to random sets, using fixed point techniques, obtaining this way stochastic analogues of earlier deterministic results by Browder-Petryshyn, KyFan and Reich. Then we prove two fixed point theorems for random multifunctions with stochastic domain that satisfy certain tangential conditions. Finally we consider a random differential inclusion with upper semicontinuous orientor field and establish the existence of random solutions.

  17. Effect of Prometheus liver assist system on systemic hemodynamics in patients with cirrhosis: a randomized controlled study

    DEFF Research Database (Denmark)

    Dethloff, T.; Tofteng, F.; Frederiksen, H.J.;

    2008-01-01

    AIM: To evaluate treatment safety and hemodynamic changes during a single 6-h treatment with the Prometheus liver assist system in a randomized, controlled study. METHODS: Twenty-four patients were randomized to either the study group or to one of two control groups: Fractionated Plasma Separation...... Adsorption and Dialysis, Prometheus system (Study group; n = 8); Molecular Adsorbent Recirculation System (MARS) (Control group 1, n = 8); or hemodialysis (Control group 2; n = 8). All patients included in the study had decompensated cirrhosis at the time of the inclusion into the study. Circulatory changes...... were monitored with a Swan-Ganz catheter and bilirubin and creatinine were monitored as measures of protein-bound and water-soluble toxins. RESULTS: Systemic hemodynamics did not differ between treatment and control groups apart from an increase in arterial pressure in the MARS group (P = 0...

  18. Development of an obstetric vital sign alert to improve outcomes in acute care obstetrics.

    Science.gov (United States)

    Behling, Diana J; Renaud, Michelle

    2015-01-01

    Maternal morbidity and mortality is a national health problem. Causal analysis of near-miss and actual serious patient safety events, including those resulting in maternal death, within obstetric units often highlights a failure to promptly recognize and treat women who were exhibiting signs of decompensation/deterioration. The Obstetric Vital Sign Alert (OBVSA) is an early warning tool that leverages discrete data points in the electronic health record, calculating a risk score that is displayed as a visual cue for acute care obstetric staff. When studied in a cohort of women with postpartum hemorrhage, use of the OBVSA reduced symptom-to-response time and intervention time, as well as key process and outcome measures. PMID:25900584

  19. Mental stress in atopic dermatitis--neuronal plasticity and the cholinergic system are affected in atopic dermatitis and in response to acute experimental mental stress in a randomized controlled pilot study.

    Directory of Open Access Journals (Sweden)

    Eva Milena Johanne Peters

    Full Text Available RATIONALE: In mouse models for atopic dermatitis (AD hypothalamus pituitary adrenal axis (HPA dysfunction and neuropeptide-dependent neurogenic inflammation explain stress-aggravated flares to some extent. Lately, cholinergic signaling has emerged as a link between innate and adaptive immunity as well as stress responses in chronic inflammatory diseases. Here we aim to determine in humans the impact of acute stress on neuro-immune interaction as well as on the non-neuronal cholinergic system (NNCS. METHODS: Skin biopsies were obtained from 22 individuals (AD patients and matched healthy control subjects before and after the Trier social stress test (TSST. To assess neuro-immune interaction, nerve fiber (NF-density, NF-mast cell contacts and mast cell activation were determined by immunohistomorphometry. To evaluate NNCS effects, expression of secreted mammal Ly-6/urokinase-type plasminogen activator receptor-related protein (SLURP 1 and 2 (endogenous nicotinic acetylcholine receptor ligands and their main corresponding receptors were assessed by quantitative RT-PCR. RESULTS: With respect to neuro-immune interaction we found higher numbers of NGF+ dermal NF in lesional compared to non-lesional AD but lower numbers of Gap43+ growing NF at baseline. Mast cell-NF contacts correlated with SCORAD and itch in lesional skin. With respect to the NNCS, nicotinic acetylcholine receptor α7 (α7nAChR mRNA was significantly lower in lesional AD skin at baseline. After TSST, PGP 9.5+ NF numbers dropped in lesional AD as did their contacts with mast cells. NGF+ NF now correlated with SCORAD and mast cell-NF contacts with itch in non-lesional skin. At the same time, SLURP-2 levels increased in lesional AD skin. CONCLUSIONS: In humans chronic inflammatory and highly acute psycho-emotional stress interact to modulate cutaneous neuro-immune communication and NNCS marker expression. These findings may have consequences for understanding and treatment of chronic

  20. Zinc deficiency in pakistani children with decompensated chronic liver disease; a cross-sectional survey at a hospital in lahore, pakistan

    International Nuclear Information System (INIS)

    This study aimed to objectively assess mean serum zinc levels and influence of age, gender and primary etiology of chronic liver disease (CLD) on these levels in a sample of Pakistani pediatric patients with decompensated CLD (DCLD). Methodology: It was a cross-sectional survey carried out at Combined Military Hospital, Lahore, from August 2013 to February 2014. Through non-probability consecutive sampling we included 100 cases belonging to both genders, fitting in the age-range of 1 - 12 years and having DCLD based on Child-Pugh classification score = 6. Patients with diarrhea, respiratory or urinary tract infection, liver tumors or receiving treatments with immune suppressants, antifungals, antivirals and zinc supplementation were excluded. Results After exclusion, off 74 cases, 58.1% were male. Majority belonged to the age group of 6 - 12 years (54.1%). Idiopathic DCLD was the most prevalent primary etiology (40.5%). Mean serum zinc levels (44.5 ± 4.7 mu g/dL) were significantly lower (p< 0.001) than the minimum normal serum zinc levels (65 micro g/dL). The mean serum zinc levels were lower significantly in children with idiopathic CLD as the primary etiology (p=0.012) and insignificantly in females and children belonging to the age group of 1- < 6 years (p= 0.08 and p= 0.59 respectively) Conclusion Mean serum zinc levels in our sample of pediatric patients with DCLD were significantly lower than the reference values for normal children, were lowest in children suffering from idiopathic CLD and were not dependent on gender and age. (author)

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

    DEFF Research Database (Denmark)

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

    2006-01-01

    hours after symptom onset. Patients were randomized to double-blind treatment with G-CSF (10 microg/kg of body weight) or placebo for 6 days. The primary end point was change in systolic wall thickening from baseline to 6 months determined by cardiac magnetic resonance imaging (MRI). An independent core...... of subcutaneous G-CSF injections on left ventricular function in patients with ST-elevation myocardial infarction. METHODS AND RESULTS: Seventy-eight patients (62 men; average age, 56 years) with ST-elevation myocardial infarction were included after successful primary percutaneous coronary stent intervention

  2. Risk Preferences under Acute Stress

    OpenAIRE

    Cingl, Lubomír; Cahlíková, Jana

    2013-01-01

    Many important decisions are made under stress and they often involve risky alternatives. There has been ample evidence that stress influences decision making in cognitive as well as in affective domains, but still very little is known about whether individual attitudes to risk change with exposure to acute stress. To directly evaluate the causal effect of stress on risk attitudes, we adopt an experimental approach in which we randomly expose participants to a psychosocial stressor in the for...

  3. 自体骨髓干细胞移植联合恩替卡韦治疗乙型肝炎肝硬化失代偿期的临床研究%Clinical study of transplantation of autologous bone marrow stem cells combined with entecavir for hepatitis B patients with decompensated cirrhosis

    Institute of Scientific and Technical Information of China (English)

    崔永辉

    2015-01-01

    目的:观察自体骨髓干细胞移植联合恩替卡韦治疗乙型肝炎肝硬化失代偿期的临床疗效。方法选取河南省商丘市第一人民医院40例初诊的乙型肝炎肝硬化失代偿期患者,随机分为2组:对照组22例予以常规保肝治疗及恩替卡韦抗病毒治疗。治疗组18例在对照组治疗的基础上,行经肝动脉途径自体骨髓干细胞移植治疗。观察两组患者2、4、8、12周的临床症状体征,谷丙转氨酶、血清白蛋白、总胆红素、凝血酶原活动度、肝纤维化四项、HBV-DNA等指标变化,比较两组患者第12周的临床症状体征及化验室指标。结果经治疗后两组患者纳差、乏力、腹胀、腹水及双下肢水肿等临床症状体征均有不同程度的改善,以治疗组明显。术后第12周两组HBV-DNA检测均低于最低检出值。经治疗后两组谷丙转氨酶、总胆红素及肝纤维化四项等指标均有不同程度下降,血清白蛋白、凝血酶原活动度等均有所改善,以治疗组明显。两组患者Child-Pugh评分及终末期肝病模型评分均较治疗前有所下降,以治疗组明显。结论自体干细胞移植联合恩替卡韦治疗失代偿期乙型肝炎肝硬化患者,能够明显改善患者的临床症状及肝脏功能。自体骨髓干细胞移植是治疗乙型肝炎肝硬化失代偿期的新的有效手段。%Objective To observe the clinical efficacy of transplantation of autologous bone marrow stem cells combined with entecavir treating hepatitis B patients with decompensated cirrhosis.Methods Forty newly diagnosed hepatitis B patients with decompensated cirrhosis in the First People′s Hospital of Shangqiu of Henan Province were randomly divided into control group and observation group.The 22 patients in control group were treated with conventional liver protected treatment and entecavir antiviral therapy.On the basis of the control group,the 18 patients in observation group

  4. Topics in random walks in random environment

    International Nuclear Information System (INIS)

    Over the last twenty-five years random motions in random media have been intensively investigated and some new general methods and paradigms have by now emerged. Random walks in random environment constitute one of the canonical models of the field. However in dimension bigger than one they are still poorly understood and many of the basic issues remain to this day unresolved. The present series of lectures attempt to give an account of the progresses which have been made over the last few years, especially in the study of multi-dimensional random walks in random environment with ballistic behavior. (author)

  5. Predicting Functional Recovery after Acute Ankle Sprain

    OpenAIRE

    Sean R O'Connor; Bleakley, Chris M; Tully, Mark A; McDonough, Suzanne M

    2013-01-01

    INTRODUCTION:Ankle sprains are among the most common acute musculoskeletal conditions presenting to primary care. Their clinical course is variable but there are limited recommendations on prognostic factors. Our primary aim was to identify clinical predictors of short and medium term functional recovery after ankle sprain.METHODS:A secondary analysis of data from adult participants (N = 85) with an acute ankle sprain, enrolled in a randomized controlled trial was undertaken. The predictive v...

  6. Acute abdomen

    Directory of Open Access Journals (Sweden)

    Wig J

    1978-01-01

    Full Text Available 550 cases of acute abdomen have been analysed in detail includ-ing their clinical presentation and operative findings. Males are more frequently affected than females in a ratio of 3: 1. More than 45% of patients presented after 48 hours of onset of symptoms. Intestinal obstruction was the commonest cause of acute abdomen (47.6%. External hernia was responsible for 26% of cases of intestinal obstruction. Perforated peptic ulcer was the commonest cause of peritonitis in the present series (31.7% while incidence of biliary peritonitis was only 2.4%.. The clinical accuracy rate was 87%. The mortality in operated cases was high (10% while the over-all mortality rate was 7.5%.

  7. Risk-Adapted Management of Acute Pulmonary Embolism: Recent Evidence, New Guidelines

    Directory of Open Access Journals (Sweden)

    Anja Käberich

    2014-10-01

    Full Text Available Venous thromboembolism (VTE, the third most frequent acute cardiovascular syndrome, may cause life-threatening complications and imposes a substantial socio-economic burden. During the past years, several landmark trials paved the way towards novel strategies in acute and long-term management of patients with acute pulmonary embolism (PE. Risk stratification is increasingly recognized as a cornerstone for an adequate diagnostic and therapeutic management of the highly heterogeneous population of patients with acute PE. Recently published European Guidelines emphasize the importance of clinical prediction rules in combination with imaging procedures (assessment of right ventricular function and laboratory biomarkers (indicative of myocardial stress or injury for identification of normotensive PE patients at intermediate risk for an adverse short-term outcome. In this patient group, systemic full-dose thrombolysis was associated with a significantly increased risk of intracranial bleeding, a complication which discourages its clinical application unless hemodynamic decompensation occurs. A large-scale clinical trial program evaluating new oral anticoagulants in the initial and long-term treatment of venous thromboembolism showed at least comparable efficacy and presumably increased safety of these drugs compared to the current standard treatment. Research is continuing on catheter-directed, ultrasound-assisted, local, low-dose thrombolysis in the management of intermediate-risk PE.

  8. Risk-adapted management of acute pulmonary embolism: recent evidence, new guidelines.

    Science.gov (United States)

    Käberich, Anja; Wärntges, Simone; Konstantinides, Stavros

    2014-10-01

    Venous thromboembolism (VTE), the third most frequent acute cardiovascular syndrome, may cause life-threatening complications and imposes a substantial socio-economic burden. During the past years, several landmark trials paved the way towards novel strategies in acute and long-term management of patients with acute pulmonary embolism (PE). Risk stratification is increasingly recognized as a cornerstone for an adequate diagnostic and therapeutic management of the highly heterogeneous population of patients with acute PE. Recently published European Guidelines emphasize the importance of clinical prediction rules in combination with imaging procedures (assessment of right ventricular function) and laboratory biomarkers (indicative of myocardial stress or injury) for identification of normotensive PE patients at intermediate risk for an adverse short-term outcome. In this patient group, systemic full-dose thrombolysis was associated with a significantly increased risk of intracranial bleeding, a complication which discourages its clinical application unless hemodynamic decompensation occurs. A large-scale clinical trial program evaluating new oral anticoagulants in the initial and long-term treatment of venous thromboembolism showed at least comparable efficacy and presumably increased safety of these drugs compared to the current standard treatment. Research is continuing on catheter-directed, ultrasound-assisted, local, low-dose thrombolysis in the management of intermediate-risk PE. PMID:25386356

  9. Post hoc analysis of the relationship between baseline white blood cell count and survival outcome in a randomized Phase III trial of decitabine in older patients with newly diagnosed acute myeloid leukemia

    Directory of Open Access Journals (Sweden)

    Arthur C

    2015-01-01

    Full Text Available Christopher Arthur,1 Jaroslav Cermak,2 Jacques Delaunay,3 Jirí Mayer,4 Grzegorz Mazur,5 Xavier Thomas,6 Agnieszka Wierzbowska,7 Mark M Jones,8 Erhan Berrak,8 Hagop Kantarjian9 1Department of Haematology, Royal North Shore Hospital, Sydney, NSW, Australia; 2Institute of Hematology and Blood Transfusion, Prague, Czech Republic; 3Department of Clinical Hematology, University of Nantes, Nantes, France; 4Department of Internal Medicine, Masaryk University Hospital Brno, Central European Institute of Technology, Brno, Czech Republic; 5Department of Hematology, Wroclaw Medical University, Wroclaw, Poland; 6Department of Hematology, Edouard Herriot Hospital, Lyon, France; 7Copernicus Memorial Hospital, Lodz, Poland; 8Oncology Product Creation Unit, Eisai Inc., Woodcliff Lake, NJ, USA; 9Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX, USA Background: In a Phase III trial, 485 patients (≥65 years with newly diagnosed acute myeloid leukemia received decitabine 20 mg/m2 intravenously for 5 days every 4 weeks or a treatment choice (supportive care or cytarabine 20 mg/m2 subcutaneously for 10 days every 4 weeks. Materials and methods: We summarized overall and progression-free survival by baseline white blood cell count using two analyses: <1, 1–5, >5×109/L; ≤10 or .10×109/L. Results: There were 446 deaths (treatment choice, n=227; decitabine, n=219. Median overall survival was 5.0 (treatment choice versus 7.7 months (decitabine; nominal P=0.037. Overall survival differences between white blood cell groups were not significant; hazard ratios (HRs favored decitabine. Significant progression-free survival differences favored decitabine for groups 1–5×109/L (P=0.005, HR =0.67, greater than 5×109/L (P=0.027, HR =0.71, and up to 10×109/L (P=0.003, HR =0.72. Conclusion: There was a trend toward improved outcome with decitabine, regardless of baseline white blood cell count. Keywords: decitabine, acute myeloid

  10. Clinical Analysis in 75 Patients with Decompensated Liver Cirrhosis of Hepatitis and Alcoholic Cirrhosis%75例肝炎肝硬化及酒精性肝硬化失代偿期临床比较分析

    Institute of Scientific and Technical Information of China (English)

    张泽进; 韦杏; 陈自仁; 吴朝文

    2013-01-01

    Objective To observe clinical manifestion of decompensated liver cirrhosis of hepatitis and alcoholic cirrhosis. Methods 75 patients with decompensateed liver cirrhosis was chosen, 38 cases of decompensated liver cirrhosis of hepatitis, and 37 cases of decompensated alcoholic cirrhosis. Then platelet,liver function,coagulative function and complication were examined. Results The data of decompensateed liver cirrhosis of platelet, liver function, coagulative function and complication were worse than those of alcoholic cirrhosis (P < 0.05). Conclus