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Sample records for antifibrinolytic trial tranexamic

  1. Tranexamic acid for upper gastrointestinal bleeding

    DEFF Research Database (Denmark)

    Gluud, Lise Lotte; Klingenberg, Sarah Louise; Langholz, Ebbe

    2012-01-01

    Tranexamic acid reduces haemorrhage through its antifibrinolytic effects. In a previous version of the present review, we found that tranexamic acid may reduce mortality. The present review includes updated searches of randomised trials on tranexamic acid versus placebo, cimetidine or lansoprazole....

  2. Antifibrinolytics in liver surgery

    Directory of Open Access Journals (Sweden)

    Jalpa Makwana

    2010-01-01

    Full Text Available Hyperfibrinolysis, a known complication of liver surgery and orthotopic liver transplantation (OLT, plays a significant role in blood loss. This fact justifies the use of antifibrinolytic drugs during these procedures. Two groups of drug namely lysine analogues [epsilon aminocaproic acid (EACA and tranexamic acid (TA] and serine-protease-inhibitors (aprotinin are frequently used for this purpose. But uniform data or guidelines on the type of antifibrinolytic drugs to be used, their indications and correct dose, is still insufficient. Antifibrinolytics behave like a double-edged sword. On one hand, there are benefits of less transfusion requirements but on the other hand there is potential complication like thromboembolism, which has been reported in several studies. We performed a systematic search in PubMed and Cochrane Library, and we included studies wherein antifibrinolytic drugs (EACA, TA, or aprotinin were compared with each other or with controls/placebo. We analysed factors like intraoperative red blood cell and fresh frozen plasma requirements, the perioperative incidence of hepatic artery thrombosis, venous thromboembolic events and mortality. Among the three drugs, EACA is least studied. Use of extensively studied drug like aprotinin has been restricted because of its side effects. Haemostatic effect of aprotinin and tranexamic acid has been comparable. However, proper patient selection and individualized treatment for each of them is required. Purpose of this review is to study various clinical trials on antifibrinolytic drugs and address the related issues like benefits claimed and associated potential complications.

  3. A comparison of high-dose and low-dose tranexamic acid antifibrinolytic protocols for primary coronary artery bypass surgery

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    Stephen M McHugh

    2016-01-01

    Full Text Available Background and Aims: Tranexamic acid (TA is used for prophylactic antifibrinolysis in coronary artery bypass surgeries to reduce bleeding. We evaluated the efficacy of two different doses of TA for prophylactic antifibrinolysis in patients undergoing primary coronary artery bypass grafting (CABG surgery in this retrospective cohort study at a tertiary care referral centre. Methods: One-hundred eighty-four patients who underwent primary CABG with cardiopulmonary bypass (CPB via sternotomy between January 2009 and June 2011 were evaluated. Pre-operative patient characteristics, intraoperative data, post-operative bleeding, transfusions, organ dysfunction and 30-day mortality were compared between high-dose TA (30 mg/kg loading dose followed by infusion of 15 mg/kg/h until the end of surgery along with 2 mg/kg priming dose in the bypass circuit and low-dose TA (15 mg/kg loading dose followed by infusion of 6 mg/kg/h until the end of surgery along with 1 mg/kg priming dose in the bypass circuit groups. Univariate comparative analysis of all categorical and continuous variables was performed between the two groups by appropriate statistical tests. Linear and logistic regression analyses were performed to control for the effect of confounding on the outcome variables. Results: Chest tube output, perioperative transfusion of blood products and incidence of re-exploration for bleeding did not differ significantly (P> 0.05 between groups. Post-operative complications and 30-day mortality were comparable between the groups. The presence of cardiogenic shock and increased pre-operative creatinine were found to be associated with increased chest tube output on the post-operative day 2 by multivariable linear regression model. Conclusions: Low-dose TA protocol is as effective as high-dose protocol for antifibrinolysis in patients undergoing primary CABG with CPB.

  4. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis

    OpenAIRE

    Meng Wang; Xin-Feng Zheng; Lei-Sheng Jiang

    2015-01-01

    Background Routine use of antifibrinolytic agents in spine surgery is still an issue of debate. Objective To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA, traditionally known as Amicar) in reducing perioperative blood loss and transfusion requirements in scoliosis surgery. Methods We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs), retrosp...

  5. Anti-hemorrhagic effect of prophylactic tranexamic acid in benign hysterectomy-a double-blinded randomized placebo-controlled trial

    DEFF Research Database (Denmark)

    Topsoee, Märta Fink; Bergholt, Thomas; Ravn, Pernille;

    2016-01-01

    BACKGROUND: Hysterectomy is one of the most frequently performed major gynecological surgical procedures. Even when the indication for the procedure is benign, relatively high complication rates have been reported. Perioperative bleeding seems to represent the most common cause of complications...... and in 2004, 8% of all women in Denmark undergoing benign hysterectomy experienced a bleeding complication. Tranexamic acid is an antifibrinolytic agent that has shown to effectively reduce bleeding complications within other surgical and medical areas. However, knowledge about the drug's effect in relation...... 2014. A total of 332 women undergoing benign abdominal, laparoscopic, or vaginal hysterectomy were included in the trial, randomized to either 1 g of intravenous tranexamic acid or placebo at start of surgery. Chi-square test and Student t test statistical analyses were applied. RESULTS: The primary...

  6. Study of Tranexamic Acid during Air Medical Prehospital Transport (STAAMP) Trial

    Science.gov (United States)

    2014-10-01

    during Air Medical Prehospital transport (STAAMP) trial PRINCIPAL INVESTIGATOR: Jason L. Sperry, MD, MPH CONTRACTING ORGANIZATION...Tranexamic acid during Air Medical Prehospital transport (STAAMP) trial 5b. GRANT NUMBER W81XWH-13-2-0080 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S...and explained the purpose of this study to Pittsburgh local and surrounding area. 15. SUBJECT TERMS Prehospital ; Tranexamic acid 16

  7. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis.

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    McCormack, Paul L

    2012-03-26

    Tranexamic acid, a synthetic derivative of the amino acid lysine, is an antifibrinolytic agent that acts by binding to plasminogen and blocking the interaction of plasmin(ogen) with fibrin, thereby preventing dissolution of the fibrin clot. Tranexamic acid (Transamin®) is indicated in Japan for use in certain conditions with abnormal bleeding or bleeding tendencies in which local or systemic hyperfibrinolysis is considered to be involved. This article reviews the efficacy and tolerability of tranexamic acid in conditions amenable to antifibrinolytic therapy and briefly overviews the pharmacological properties of the drug. In large, randomized controlled trials, tranexamic acid generally significantly reduced perioperative blood loss compared with placebo in a variety of surgical procedures, including cardiac surgery with or without cardiopulmonary bypass, total hip and knee replacement and prostatectomy. In many instances, tranexamic acid also reduced transfusion requirements associated with surgery. It also reduced blood loss in gynaecological bleeding disorders, such as heavy menstrual bleeding, postpartum haemorrhage and bleeding irregularities caused by contraceptive implants. Tranexamic acid significantly reduced all-cause mortality and death due to bleeding in trauma patients with significant bleeding, particularly when administered early after injury. It was also effective in traumatic hyphaema, gastrointestinal bleeding and hereditary angioneurotic oedema. While it reduces rebleeding in subarachnoid haemorrhage, it may increase ischaemic complications. Pharmacoeconomic analyses predicted that tranexamic acid use in surgery and trauma would be very cost effective and potentially life saving. In direct comparisons with other marketed agents, tranexamic acid was at least as effective as ε-aminocaproic acid and more effective than desmopressin in surgical procedures. It was more effective than desmopressin, etamsylate, flurbiprofen, mefenamic acid and

  8. Double blind, placebo-controlled trial of Tranexamic acid on recent internal hemorrhoid bleeding

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    Abdul A. Rani

    2002-12-01

    Full Text Available Double blind randomized placebo controlled trial was conducted to evaluate the efficacy of Tranexamic acid in 54 patients with recent hemorrhoid bleeding. Age, gender, body weight, height, grade of hemorrhoid, time of onset of recent bleeding were comparable between two groups. Analysis of haemostatic effect or stop bleeding as an immediate outcome of this study revealed that in the grade 2 patients, 23/23 (100% of tranexamic group and 18/23(78.26% of placebo group the bleeding stop. After 3 days of observation, there was statistically significant different for the rate of stop bleeding as well as at the end of observation. Bleeding stop earlier in the Tranexamic group with median 4 days (3-5 days, compare to placebo, median 11(9.55-12.45. Analysis of recurrent bleeding as an outcome of this study revealed that in the placebo group 9/18(50% of grade 2 patients and all grade 3 (100%patients suffered from recurrent bleeding. Since the days 4, both group have significant different time for recurrent bleeding and at the end of observation, cumulative probability of free of bleeding between two groups significantly different. Median still stop bleeding in the placebo group was 36 days, and the tranexamic group never reaches the median until the end of observation. Conclusion: tranexamic acid was an effective drug to stop recent hemorrhoid bleeding and prevent further recurrent bleeding, significantly better than placebo. (Med J Indones 2002;11: 215-21Keywords: Tranexamic acid, hemorrhoid bleeding, haemostatic effect, recurrent bleeding.

  9. Tranexamic acid for upper gastrointestinal bleeding.

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    Bennett, Cathy; Klingenberg, Sarah Louise; Langholz, Ebbe; Gluud, Lise Lotte

    2014-11-21

    Background Tranexamic acid reduces haemorrhage through its antifibrinolytic effects. In a previous version of the present review, we found that tranexamic acid may reduce mortality. This review includes updated searches and new trials.Objectives To assess the effects of tranexamic acid versus no intervention, placebo or other antiulcer drugs for upper gastrointestinal bleeding.Search methods We updated the review by performing electronic database searches (Cochrane Central Register of Controlled Trials (CENTRAL),MEDLINE, EMBASE, Science Citation Index) and manual searches in July 2014.Selection criteriaRandomised controlled trials, irrespective of language or publication status.Data collection and analysis We used the standard methodological procedures of the The Cochrane Collaboration. All-cause mortality, bleeding and adverse events were the primary outcome measures. We performed fixed-effect and random-effects model meta-analyses and presented results as risk ratios (RRs) with 95% confidence intervals (CIs) and used I² as a measure of between-trial heterogeneity. We analysed tranexamic acid versus placebo or no intervention and tranexamic acid versus antiulcer drugs separately. To analyse sources of heterogeneity and robustness of the overall results, we performed subgroup, sensitivity and sequential analyses.Main results We included eight randomised controlled trials on tranexamic acid for upper gastrointestinal bleeding. Additionally, we identified one large ongoing pragmatic randomised controlled trial from which data are not yet available. Control groups were randomly assigned to placebo (seven trials) or no intervention (one trial). Two trials also included a control group randomly assigned to antiulcer drugs(lansoprazole or cimetidine). The included studies were published from 1973 to 2011. The number of participants randomly assigned ranged from 47 to 216 (median 204). All trials reported mortality. In total, 42 of 851 participants randomly assigned to

  10. CRASH-2 Study of Tranexamic Acid to Treat Bleeding in Trauma Patients: A Controversy Fueled by Science and Social Media

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    Sophia Binz

    2015-01-01

    Full Text Available This paper reviews the application of tranexamic acid, an antifibrinolytic, to trauma. CRASH-2, a large randomized controlled trial, was the first to show a reduction in mortality and recommend tranexamic acid use in bleeding trauma patients. However, this paper was not without controversy. Its patient recruitment, methodology, and conductance in moderate-to-low income countries cast doubt on its ability to be applied to trauma protocols in countries with mature trauma networks. In addition to traditional vetting in scientific, peer-reviewed journals, CRASH-2 came about at a time when advances in communication technology allowed debate and influence to be leveraged in new forms, specifically through the use of multimedia campaigns, social media, and Internet blogs. This paper presents a comprehensive view of tranexamic acid utilization in trauma from peer-reviewed evidence to novel multimedia influences.

  11. CRASH-2 Study of Tranexamic Acid to Treat Bleeding in Trauma Patients: A Controversy Fueled by Science and Social Media.

    Science.gov (United States)

    Binz, Sophia; McCollester, Jonathon; Thomas, Scott; Miller, Joseph; Pohlman, Timothy; Waxman, Dan; Shariff, Faisal; Tracy, Rebecca; Walsh, Mark

    2015-01-01

    This paper reviews the application of tranexamic acid, an antifibrinolytic, to trauma. CRASH-2, a large randomized controlled trial, was the first to show a reduction in mortality and recommend tranexamic acid use in bleeding trauma patients. However, this paper was not without controversy. Its patient recruitment, methodology, and conductance in moderate-to-low income countries cast doubt on its ability to be applied to trauma protocols in countries with mature trauma networks. In addition to traditional vetting in scientific, peer-reviewed journals, CRASH-2 came about at a time when advances in communication technology allowed debate and influence to be leveraged in new forms, specifically through the use of multimedia campaigns, social media, and Internet blogs. This paper presents a comprehensive view of tranexamic acid utilization in trauma from peer-reviewed evidence to novel multimedia influences.

  12. Temporal changes in clot lysis and clot stability following tranexamic acid in cardiac surgery

    DEFF Research Database (Denmark)

    Tang, Mariann; Wierup, Per; Rea, Catherine J;

    2016-01-01

    Cardiac surgery induces a multifactorial coagulopathy. Regular use of tranexamic acid (TXA) is becoming standard of care. Clinical challenges include selecting optimal dosing regimen and balancing the benefit versus risk of additional dosing with antifibrinolytics. The objective was to evaluate...

  13. Tranexamic Acid for Trauma Patients: A Critical Review of the Literature

    Science.gov (United States)

    2011-07-01

    pediatric urinary tract surgery,20 ruptured intracranial aneurysms ,21 oral surgery22 gynecologic surgery,23 treatment of hereditary angioneurotic edema,24...20. Ro JS, Knutrud O, Stormorken H. Antifibrinolytic treatment with tranexamic acid (AMCA) in pediatric urinary tract surgery. J Pediatr Surg...1970;5:315–320. 21. Gibbs JR, Corkill AG. Use of an anti-fibrinolytic agent (tranexamic acid) in the management of ruptured intracranial aneurysms

  14. Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis.

    Directory of Open Access Journals (Sweden)

    Meng Wang

    Full Text Available Routine use of antifibrinolytic agents in spine surgery is still an issue of debate.To gather scientific evidence for the efficacy and safety of antifibrinolytic agents including aprotinin, tranexamic acid (TXA and epsilon aminocaproic acid (EACA, traditionally known as Amicar in reducing perioperative blood loss and transfusion requirements in scoliosis surgery.We conducted a systematic review and meta-analysis for randomized controlled trials (RCTs, retrospective case-control studies, and retrospective cohort studies on the use of antifibrinolytic agents in scoliosis surgery by searching in the MEDLINE and EMBASE databases and the Cochrane Database of Systematic Reviews and Controlled Trials of papers published from January 1980 through July 2014. Safety of the antifibrinolytic agents was evaluated in all included studies, while efficacy was evaluated in RCTs.Eighteen papers with a total of 1,158 patients were eligible for inclusion in this study. Among them, 8 RCTs with 450 patients were included for evaluation of pharmacologic efficacy (1 RCT was excluded because of a lack of standard deviation data. Mean blood loss was reduced in patients with perioperative use of antifibrinolytic agents by 409.25 ml intraoperatively (95% confidence interval [CI], 196.57-621.94 ml, 250.30 ml postoperatively (95% CI, 35.31-465.30, and 601.40 ml overall (95% CI, 306.64-896.16 ml. The mean volume of blood transfusion was reduced by 474.98 ml (95% CI, 195.30-754.67 ml. The transfusion rate was 44.6% (108/242 in the patients with antifibrinolytic agents and 68.3% (142/208 in the patients with placebo. (OR 0.38; 95% CI; 0.25-0.58; P<0.00001, I2 = 9%. All studies were included for evaluation of safety, with a total of 8 adverse events reported overall (4 in the experimental group and 4 in the control group.The systematic review and meta-analysis indicated that aprotinin, TXA, and EACA all significantly reduced perioperative blood loss and transfusion requirements

  15. Tranexamic acid reduces blood loss during and after cesarean section:A double blinded, randomized, controlled trial

    Institute of Scientific and Technical Information of China (English)

    Amr H Yehia; Magdy H Koleib; Ibrahim A Abdelazim; Ahmed Atik

    2014-01-01

    Objective:To evaluate the efficacy of tranexamic acid in reduction of blood loss during and after cesarean section.Methods:Women included in the current double blinded, randomized, controlled trial were recruited from women attending for elective cesarean section and randomized into two groups; study group: received tranexamic acid with induction of anesthesia plus10IU of oxytocin injection after delivery of the baby.Control group: received only oxytocin 10IU injection after delivery of the baby.Results:Twenty four hours post-operative hemoglobin level was significantly higher in study group(11.2±1.5 mg/dL) compared to control(9.6±1.2 mg/dL), also24 hours post-operative hematocrit was significantly higher in study group(30.2±6.6) compared to control(29.2±2.8).Calculated total blood loss from placental delivery till end of cesarean section was significantly less in study group compared to control(369.5±198.0 versus606.8±193.0 mL; respectively), also, calculated vaginal bleeding during first6 hours post-operative was significantly less in study group compared to control(85.0±30.7 mL versus130.8±49.3 mL, respectively).The incidence of post-partum hemorrhage was significantly less in study group compared to control(31.1% versus63.2%; respectively), also the need for iron replacement therapy was significantly less frequent in study group compared to control(0.9% versus6.6%, respectively). Conclusions:Tranexamic acid can be used safely to reduce blood loss during cesarean section. Reduced blood loss after tranexamic acid was associated with improvement of post-operative hemoglobin, hematocrit and with reduction of post-partum need for iron replacement.

  16. Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): protocol and statistical analysis plan for a randomized controlled trial.

    Science.gov (United States)

    Shakur, Haleema; Fawole, Bukola; Kuti, Modupe; Olayemi, Oladapo; Bello, Adenike; Ogunbode, Olayinka; Kotila, Taiwo; Aimakhu, Chris O; Huque, Sumaya; Gregg, Meghann; Roberts, Ian

    2016-12-16

    Background: Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid has the potential to reduce bleeding and a large randomized controlled trial of its effect on maternal health outcomes in women with PPH (The WOMAN trial) is ongoing. We will examine the effect of tranexamic acid on fibrinolysis and coagulation in a subset of WOMAN trial participants. Methods. Adult women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion in the WOMAN trial. In a sub-group of trial participants, blood samples will be collected at baseline and 30 minutes after the first dose of tranexamic acid or matching placebo.  Our primary objective is to evaluate the effect of tranexamic acid on fibrinolysis. Fibrinolysis will be assessed by measuring D-dimers and by rotational thromboelastometry (ROTEM). Secondary outcomes are international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, haemoglobin and platelets. We aim to include about 180 women from the University College Hospital, Ibadan in Nigeria. Discussion:  This sub-study of WOMAN trial participants should provide information on the mechanism of action of tranexamic acid in women with postpartum haemorrhage. We present the trial protocol and statistical analysis plan. The trial protocol was registered prior to the start of patient recruitment. The statistical analysis plan was completed before un-blinding. Trial registration: The trial was registered: ClinicalTrials.gov, Identifier NCT00872469 https://clinicaltrials.gov/ct2/show/NCT00872469; ISRCTN registry, Identifier ISRCTN76912190 http://www.isrctn.com/ISRCTN76912190 (Registration date: 22/03/2012).

  17. Accidental Intrathecal Injection of Tranexamic Acid

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    Khaled Mahmoud

    2012-01-01

    Full Text Available Tranexamic acid (TXA is a popular antifibrinolytic drug that is commonly used in patients with bleeding disorder. Major morbidities and mortalities have been reported following inadvertent intrathecal injection of TXA. In this paper, inadvertent intrathecal injection of TXA has resulted from similarities in appearance between TXA and heavy bupivacaine 0.5% ampoules. The patient experienced severe pain in the back and gluteal region upon injection in association with systemic hypertension and tachycardia followed by generalized myoclonic seizures and ventricular fibrillation.

  18. A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty.

    Science.gov (United States)

    Georgiadis, Andrew G; Muh, Stephanie J; Silverton, Craig D; Weir, Robb M; Laker, Michael W

    2013-09-01

    Tranexamic acid (TNA) reduces postoperative blood loss in general and obstetrical surgery but there is limited orthopaedic literature regarding its use in the topical setting. To study the effect of topical TNA after primary total knee arthroplasty (TKA), 101 patients were randomized to topical administration of 2.0g TNA in 75mL of normal saline (50 patients) or placebo (51 patients). Operative technique, drug administration, and venous thromboembolism prophylaxis were standardized. All patients underwent screening ultrasound of the operative extremity. Total blood loss was lower in the TNA group (940.2±327.1mL) than the placebo group (1293.1±532.7mL)(P<0.001), and four patients in the placebo group and none in the TNA group received postoperative transfusion (P=0.118). We recommend administration of topical TNA in primary TKA in healthy patients to decrease perioperative blood loss.

  19. Use of intravenous tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    FU De-jie; CHEN Cheng; GUO Lin; YANG Liu

    2013-01-01

    Objective:The effect of tranexamic acid (TA) on patients receiving total knee arthroplasty (TKA) has been reported in many small clinical trials.But single trials are not sufficient enough to clarify the effectiveness and safety of TA.So,we carried out a meta-analysis of randomized controlled trials to investigate the efficacy and safety of the intravenous use of TA in TKA.Methods:Literatures were retrieved in Cochrane Library,OVID,PubMed,EMBASE,CNKI and Wanfang Data.All the related literatures were checked by two independent investigators and only the high quality randomized controlled trials were enrolled.Relevant data were analyzed using RevMan 5.1 to compare the difference of blood loss,transfusion and complications between TA group and control group.Results:There were 353 related literatures and only 22 randomized controlled trials met the inclusion criteria.The use of TA in TKA significantly reduced total blood loss by a mean of 435.41 ml (95% CI300.62-570.21,P<0.01),postoperative blood loss by a mean of 406.69 ml (95% CI333.16-480.22,P<0.01).TA also significantly lowered the transfusion rate (risk difference 0.30,95% CI0.21-0.39,P<0.01) and transfusion volume (mean difference 0.95 unit,95% CI0.53-1.37,P<0.01).The risks between TA group and control group in developing deep vein thrombosis and pulmonary embolism were not statistically significant.Conclusion:TA is beneficial for patients undergoing TKA,which can significantly reduce total blood loss,postoperative blood loss,transfusion rate,and transfusion volume.Meanwhile TA is recommended to reduce deep vein thrombosis and pulmonary embolism following TKA.

  20. Simple, rapid, and sensitive liquid chromatography-fluorescence method for the quantification of tranexamic acid in blood

    NARCIS (Netherlands)

    J.F. Huertas-Perez; M. Heger; H. Dekker; H. Krabbe; J. Lankelma; F. Ariese

    2007-01-01

    Tranexamic acid (TA) is a synthetic antifibrinolytic agent that is being considered as a candidate adjuvant drug for site-specific pharmaco-laser therapy of port wine stains. For drug utility studies, a high-performance liquid chromatography (HPLC)-fluorescence method was developed for the quantific

  1. Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage

    DEFF Research Database (Denmark)

    Sprigg, Nikola; Robson, Katie; Bath, Philip

    2016-01-01

    RATIONALE: Outcome after intracerebral hemorrhage remains poor. Tranexamic acid is easy to administer, readily available, inexpensive, and effective in other hemorrhagic conditions. AIM: This randomized trial aims to test the hypothesis that intravenous tranexamic acid given within 8 h of spontan...

  2. Safety and efficacy of tranexamic acid in bleeding paediatric trauma patients: a systematic review protocol

    Science.gov (United States)

    Urban, Denisa; Dehaeck, Ruben; Lorenzetti, Diane; Guilfoyle, Jonathan; Poon, Man-Chiu; Steele, MacGregor; Lardner, David; Ma, Irene Wai Yan; Brindle, Mary Elizabeth

    2016-01-01

    Introduction Trauma is the leading cause of death among children aged 1–18. Studies indicate that better control of bleeding could potentially prevent 10–20% of trauma-related deaths. The antifibrinolytic agent tranexamic acid (TxA) has shown promise in haemorrhage control in adult trauma patients. However, information on the potential benefits of TxA in children remains sparse. This review proposes to evaluate the current uses, benefits and adverse effects of TxA in the bleeding paediatric trauma population. Methods and analysis A structured search of bibliographic databases (eg, MEDLINE, EMBASE, PubMed, CINAHL, Cochrane CENTRAL) has been undertaken to retrieve randomised controlled trials and cohort studies that describe the use of TxA in paediatric trauma patients. To ensure that all relevant data were captured, the search did not contain any restrictions on language or publication time. After deduplication, citations will be screened independently by 2 authors, and selected for inclusion based on prespecified criteria. Data extraction and risk of bias assessment will be performed independently and in duplicate. Meta-analytic methods will be employed wherever appropriate. Ethics and dissemination This study will not involve primary data collection, and formal ethical approval will therefore not be required. The findings of this study will be disseminated through a peer-reviewed publication and at relevant conference meetings. Trial registration number CRD42016038023. PMID:27660323

  3. Effect of antifibrinolytic drugs on transfusion requirement and blood loss during orthotopic liver transplantation: Results from a single center

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    Devi A

    2008-01-01

    Full Text Available Background: During orthotopic liver transplantation (OLT, activation of the fibrinolytic system can contribute significantly to perioperative bleeding. Prophylactic administration of antifibrinolytic agents has been shown to reduce blood loss and the need for allogenic transfusion. Objective: To study the effect of antifibrinolytics on requirement of blood components, blood loss and operative time during OLT in patients with end stage liver disease, reporting to a single centre. Materials and Methods: Consecutive patients who underwent OLT at this centre during the period February 2003-October 2007 were the subjects of this study. Based on the individual anesthesiologist′s preference, patients were assigned to receive either two million units of aprotinin (AP as a bolus followed by 5,00,000 units/hour or 10 mg/kg tranexamic acid (TAas a bolus followed by 10 mg/kg every six to eight hours, administered from the induction till the end of the surgery. Transfusion policy was standardized in all patients. Intraoperative red cell salvage was done wherever possible. The effect of these two antifibrinolytic drugs on transfusion requirement was evaluated as a whole and in a sub group of patients from each treatment group and compared with a concurrent control group that did not receive antifibrinolytic drugs. Results: Fifty patients (40 M / 10 F, 44 adults, 6 pediatric patients underwent OLT in the study period. Fourteen patients were given AP, 25 patients were given TA and 11 patients did not receive any of the agents(control group. The median volume of total blood components transfused in antifibrinolytic group (n=39 was 4540 ml(0-19,200ml, blood loss 5 l(0.7-35l and operative time 9h (4.5-17h and that of control group(n=11 was 5700 ml(0-15,500ml, 10 l(0.6-25 l and 9h (6.4-15.8h respectively. The median volume of blood transfusions, blood loss and operative time was lesser in AP group(n=14 than that of TA group(n=25. Conclusion: There is definite

  4. Tranexamic Acid for Trauma Resuscitation in the United States of America.

    Science.gov (United States)

    Walsh, Mark; Thomas, Scott; Moore, Ernest; Moore, Hunter; Piscoya, Andres; Hake, Daniel; Son, Michael; Pohlman, Tim; Wegner, Julie; Bryant, John; Grassetto, Alberto; Davis, Patrick; Nielsen, Nathan; Crepinsek, Anton; Shreve, Jacob T; Castellino, Francis

    2017-03-01

    The utilization of tranexamic acid (TXA) for the management of bleeding trauma patients has been a subject of much debate on both sides of the Atlantic and in Australia. As a result of the large randomized controlled study called the Clinical Randomization of an Antifibrinolytic in Severe Hemorrhage (CRASH-2), there was an initial enthusiasm for the use of TXA to treat bleeding patients. However, the adoption of TXA in the United States was delayed by concerns of "knowledge and evidence gaps" of the CRASH-2 study and because of a lack of mechanistic rationale that would explain the survival benefit noted in the study. Subsequent nonrandomized controlled trials questioned the liberal use of TXA in trauma patients. This narrative review explores the historical as well as clinical and theoretical grounds for the more measured use of TXA in the United States and proposes a clinical and point-of-care guided utilization of TXA, blood components, and adjunctive hemostatic agents in bleeding trauma patients.

  5. Preventive and therapeutic effects of tranexamic acid on postpartum bleeding

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    Samaneh Solltani

    2014-12-01

    Full Text Available Postpartum hemorrhage is among the leading causes of maternal mortality throughout the world. Severe blood loss contributes to  the increased blood transfusion risk with its concerned inherent adverse events and therefore increased rate of emergency re-operative interventions such as arterial ligation or hysterectomy. It also can lead to protracted anemia, particularly in low or median income countries. Extended application of antifibrinolytic agents such as tranexamic acid has been customary for long years to stop or reduce blood loss in postpartum period. However, there are not enough reliable evidence to approve the real efficacy of these drugs. In this brief and summary review, we pointed to a few conducted studies. The PubMed was searched for keyword including postpartum hemorrhage, tranexamic acid, cesarean section, vaginal delivery, and blood loss prevention. The articles with language other than English were excluded from our review.  We concluded that more convincing information is needed to determine the precise effects of tranexamic acid, and its benefits against adverse effects.

  6. Use of tranexamic acid for controlling bleeding in thoracolumbar scoliosis surgery with posterior instrumentation

    Directory of Open Access Journals (Sweden)

    Vinícius Magno da Rocha

    2015-04-01

    Full Text Available OBJECTIVE: Scoliosis surgery involves major blood loss and frequently requires blood transfusion. The cost and risks involved in using allogeneic blood have motivated investigation of methods capable of reducing patients' bleeding during operations. One of these methods is to use antifibrinolytic drugs, and tranexamic acid is among these. The aim of this study was to assess the use of this drug for controlling bleeding in surgery to treat idiopathic scoliosis.METHODS: This was a retrospective study in which the medical files of 40 patients who underwent thoracolumbar arthrodesis by means of a posterior route were analyzed. Of these cases, 21 used tranexamic acid and were placed in the test group. The others were placed in the control group. The mean volumes of bleeding during and after the operation and the need for blood transfusion were compared between the two groups.RESULTS: The group that used tranexamic acid had significantly less bleeding during the operation than the control group. There was no significant difference between the groups regarding postoperative bleeding and the need for blood transfusion.CONCLUSIONS: Tranexamic acid was effective in reducing bleeding during the operation, as demonstrated in other studies. The correlation between its use and the reduction in the need for blood transfusion is multifactorial and could not be established in this study. We believe that tranexamic acid may be a useful resource and that it deserves greater attention in randomized double-blind prospective series, with proper control over variables that directly influence blood loss.

  7. A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA to epsilon aminocaproic acid (EACA for corrective spinal surgery

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    Vaz Kenneth M

    2010-04-01

    Full Text Available Abstract Background Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA to epsilon aminocaproic acid (EACA in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Methods/Design Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS, neuromuscular scoliosis (NMS, and adult deformity (AD via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. Discussion The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. Trial Registration ClinicalTrials.gov ID: NCT00958581

  8. Oral tranexamic acid with fluocinolone-based triple combination cream versus fluocinolone-based triple combination cream alone in melasma: An open labeled randomized comparative trial

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    Tanmay Padhi

    2015-01-01

    Full Text Available Background : Melasma is a common acquired cause of facial hyperpigmentation with no definitive therapy. Tranexamic acid, a plasmin inhibitor, has demonstrated depigmenting properties and combining this oral drug with other modalities of treatment has shown promising results. Objectives : To compare the efficacy of a combination of oral tranexamic acid and fluocinolone-based triple combination cream with that of fluocinolone-based triple combination cream alone in melasma among Indian patients. Materials and Methods : 40 patients of melasma of either sex attending to dermatology OPD were enrolled in this study. Participants were randomly divided into two groups with 20 patients in each group. Group A patients were asked to apply the cream only and Group B patients received oral tranexamic acid 250 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01%, tretinoin 0.05%, and hydroquinone 2% once daily for 8 weeks. Response was evaluated using melasma area severity index (MASI at baseline, 4 weeks, and 8 weeks. Results : 40 patients completed the study. The MASI scores at baseline, 4 weeks and 8 weeks in group A were 15.425 + 1.09, 11.075 + 9.167 and 6.995 + 6.056 respectively and in group B 18.243 + 1.05, 6.135 + 4.94 and 2.19 + 3.38. Intergroup comparison showed a faster reduction in pigmentation in Group B as compared to Group A and the results were statistically significant at 4 weeks (P value 0.014 and 8 weeks (P value 0.000. The efficacy was maintained throughout the 6-month follow-up period. Conclusion: Addition of oral tranexamic acid to fluocinolone-based triple combination cream results in a faster and sustained improvement in the treatment of melasma.

  9. Systematic review: tranexamic acid for upper gastrointestinal bleeding

    DEFF Research Database (Denmark)

    Klingenberg, S.L.; Langholz, S.E.; Gluud, Lise Lotte

    2008-01-01

    and Science Citation Index were combined. Intention-to-treat random effect meta-analyses were performed and results presented as RRs with 95% confidence intervals. RESULTS: Seven double-blind randomized trials on tranexamic acid vs. placebo were included. Of 1754 patients randomized, 21% were excluded. Only...

  10. Tranexamic Acid in the Management of Upper Gastrointestinal Bleeding: an Evidence-based Case Report

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    Nur Atikah

    2015-04-01

    Full Text Available Aim: to review the effectiveness of tranexamic acid therapy which has been proposed to reduce bleeding and in turn lower mortality rate. Methods: following literature searching based on our clinical question on Cochrane Library, PubMed, Clinical Key, EBSCO, Science Direct and Proquest, one systematic review that includes seven randomized controlled trials is obtained. The article meets validity and relevance criteria. Results: the systematic review found that there is no any clear evidence between intervention and control groups in term of mortality. Conclusion: the use of tranexamic acid to reduce mortality in patients with upper gastrointestinal bleeding is not recommended. Key words: tranexamic acid, mortality, upper gastrointestinal bleeding.

  11. Economic impact of tranexamic acid in healthy patients undergoing primary total hip and knee arthroplasty.

    Science.gov (United States)

    Gillette, Blake P; Maradit Kremers, Hilal; Duncan, Christopher M; Smith, Hugh M; Trousdale, Robert T; Pagnano, Mark W; Sierra, Rafael J

    2013-09-01

    Tranexamic acid (TA) has been shown to reduce perioperative blood loss and blood transfusion. While concern remains about the cost of antifibrinolytic medication, we hypothesized that routine use of tranexamic acid would result in lower direct hospital total cost by decreasing costs associated with blood transfusion, laboratory testing, and room & board. Patients with an American Society of Anesthesiologists (ASA) class II or less undergoing primary total hip or knee arthroplasty at a single institution during 2007-2008 were retrospectively reviewed. The estimated mean direct hospital total cost, operating room, blood/lab, room & board, and pharmacy costs were compared between patients who did and did not receive TA. The study population included 1018 patients, and 580 patients received TA. The mean direct total cost of hospitalization with and without TA was $15,099 and $15,978 (P<.0002) respectively, a difference of $879. The only increased cost associated with TA was the pharmacy cost which was $921 versus $781 (P<.0001). The routine use of tranexamic acid TA was associated with lower mean direct hospital total costs after primary total hip and knee arthroplasty as the increase in pharmacy costs was more than offset by cost savings in other categories.

  12. Efficacy of tranexamic acid in reducing blood loss in posterior lumbar spine surgery for degenerative spinal stenosis with instability: a retrospective case control study

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    Endres Stefan

    2011-11-01

    Full Text Available Abstract Background Degenerative spinal stenosis and instability requiring multilevel spine surgery has been associated with large blood losses. Factors that affect perioperative blood loss include time of surgery, surgical procedure, patient height, combined anterior/posterior approaches, number of levels fused, blood salvage techniques, and the use of anti-fibrinolytic medications. This study was done to evaluate the efficacy of tranexamic acid in reducing blood loss in spine surgery. Methods This retrospective case control study includes 97 patients who had to undergo surgery because of degenerative lumbar spinal stenosis and instability. All operations included spinal decompression, interbody fusion and posterior instrumentation (4-5 segments. Forty-six patients received 1 g tranexamic acid intravenous, preoperative and six hours and twelve hours postoperative; 51 patients without tranexamic acid administration were evaluated as a control group. Based on the records, the intra- and postoperative blood losses were measured by evaluating the drainage and cell saver systems 6, 12 and 24 hours post operation. Additionally, hemoglobin concentration and platelet concentration were reviewed. Furthermore, the number of red cell transfusions given and complications associated with tranexamic acid were assessed. Results The postoperative hemoglobin concentration demonstrated a statistically significant difference with a p value of 0.0130 showing superiority for tranexamic acid use (tranexamic acid group: 11.08 g/dl, SD: 1.68; control group: 10.29 g/dl, SD: 1.39. The intraoperative cell saver volume and drainage volume after 24 h demonstrated a significant difference as well, which indicates a less blood loss in the tranexamic acid group than the control group. The postoperative drainage volume at12 hours showed no significant differences; nor did the platelet concentration Allogenic blood transfusion (two red cell units was needed for eight patients

  13. EFFECT OF TRANEXAMIC ACID IN CONTROL OF PERIOPERATIVE BLOOD LOSS ASSOCIATE WITH TOTAL KNEE REPLACEMENT OUR EXPERIENCE

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    Bhaskar

    2015-05-01

    Full Text Available BACKGROUND : Costs of allogenic blood transfusions and the associated risks mandate strategies to reduce blood loss in surgery. The objective of this study was to asse ss the efficacy of antifibrinolytic treatment in reducing perioperative blood loss during total knee replacement. MATERIALS AND METHOD S: A prospective study was carried out on 148patients undergoing total knee replacement. 88pts received tranexamic acid 10 mg kg −1 i.v. just before the cementation, 3hours post op and 6 hrs later.60 patients did not receive tranexamic acid. External perioperative blood loss was measured by post op amount of drain, and Hb levels and Hematocrit. The number of patients transfuse d and number of packed red cell (PRC units transfused was recorded and possible postoperative thrombo embolic complications were studied clinically. RESULTS : Amongst 78 pts who were given Cyclokapron, only 10(12.8% were given blood transfusions and the a verage transfusions were 3.9 units and Amongst 70 pts who were not given Cyclokapron, 20(28.5% were given blood transfusions and the average transfusions were 8.7 units. The average blood loss in the group of patients who were given cyclokapron was 1004ml while in the groups which were not given the average blood loss was 1507ml. Clinical assessment did not reveal any thromboembolic complications. CONCLUSIONS : Antifibrinolytic agents produce a significant decrease in blood loss in patients undergoing total knee replacement, reflected in a reduction in the number of blood transfusions required. Based on this study we can conclude that three doses of IV tranexamic acid of 10mg/kg, can be used in TKR procedures with proven effectiveness and efficiency to decre ase postoperative blood loss in patients undergoing TKR.

  14. Perioperative tranexamic acid in day-case paediatric tonsillectomy

    Science.gov (United States)

    Thorning, G

    2014-01-01

    Introduction Tranexamic acid has been used for many years to minimise blood loss during surgery and, more recently, to reduce morbidity after major trauma. While small studies have confirmed reduction in blood loss during tonsillectomy with its use, the rate of primary haemorrhage following tonsillectomy has not been reported. In the UK, less than 50% of children having a tonsillectomy are managed as day cases, partly because of concerns about bleeding during the initial 24 hours following surgery. Methods A retrospective review of clinical records between January 2007 and January 2013 produced 476 children between the ages of 3 and 16 years who underwent Coblation™ tonsillectomy, with or without adenoidectomy and/or insertion of ventilation tubes. All children were ASA (American Society of Anesthesiologists) grade 1 or 2 and anaesthetised using a standard day surgery protocol. Following induction of anaesthesia, all received intravenous tranexamic acid at a dose of 10–15mg/kg. Results Two children (0.4%) had minor bleeding within two hours of surgery. Both returned to theatre for haemostasis and were discharged home later the same day with no further complications. The expected rate for primary haemorrhage in the UK using this technique for tonsillectomy is 1%. Conclusions Perioperative tranexamic acid in a single, parenteral dose might reduce the incidence of primary haemorrhage following paediatric tonsillectomy, facilitating discharge on the day of surgery. The results from this observational study indicate a potential benefit and need for a large, prospective, multicentre, randomised controlled trial. PMID:24780670

  15. Role of Local Infiltration of Tranexamic Acid in Reducing Blood Loss in Peritrochanteric Fracture Surgery in the Elderly Population

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    Virani SR

    2016-11-01

    Full Text Available Introduction: Peritrochanteric fractures are common injuries occurring in elderly patients. Surgeries for these fractures are associated with significant blood loss. Intravenous tranexamic acid has a proven track record in many orthopaedic surgeries including trauma, arthroplasty and spine surgeries. Objective: To study the effect of local subfascial and intramuscular infiltration of tranexamic acid in reducing blood loss and the requirement for blood transfusion in intertrochanteric fracture surgery. Study Design: Single centre prospective analytical study. Materials and Methods: One hundred and thirty seven patients above 65 years of age were included in the study, divided into two groups: the intervention group received subfascial and intramuscular infiltration of 2g tranexamic acid before wound closure and the control group of alternate patients did not receive any tranexamic acid infiltration. The postoperative drain output was recorded, as well as the haemoglobin level and the patients needing blood transfusion. Results and Conclusions: The preoperative and postoperative haemoglobin values were recorded. The mean preoperative haemoglobin was 10.9% and 10.8% (p=0.79 in the trial and control groups respectively. The mean postoperative haemoglobin was 9.5gm% and 9.2gm% (p=0.36 in the two groups. The total postoperative blood loss in the tranexamic acid group and the control group was 190.3ml and 204.3ml respectively (p=0.25. Ten patients (14.9% in the intervention group and 12 patients (17.1% in the control group required blood transfusion. We conclude that tranexamic acid does not play a significant role in reducing postoperative blood loss and blood transfusion when used locally in peritochanteric fracture surgery. However a larger double blinded study comparing various modalities of use of tranexamic acid is needed to conclusively establish its role.

  16. Acute arterial thrombosis associated with inadvertent high dose of tranexamic acid

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    Surjya Prasad Upadhyay

    2013-01-01

    Full Text Available Tranexamic acid (TA act as anti-fibrinolytic agent and is widely used to limit bleeding in clinical practice. Tranexemic acid bind with plasminogen and prevent its conversion to plasmin, which limits the fibrinolytic pathway, so there is a theoretical risk of increasing thrombosis with high or prolonged therapy with TA. We encountered a case of acute arterial thrombosis following inadvertent administration of high dose of TA. A 27-years-old male with no other co-morbidity was ordered intravenous 1 gm TA to control excessive bleeding from previous bladder injury, but by mistake, he received 10 gm of TA. The patient developed signs and symptoms of acute ischemia in the right lower limb, which was diagnosed as acute iliac arterial thrombosis by computed tomography (CT angiography. The patient was managed with systemic heparinization, fasciotomy for impending gangrene and other supportive care following which he recovered fully within a few days. Caution should be exercised for all prophylactic use, especially with high dosage or prolonged therapy with TA.

  17. Uterine Balloon Tamponade in Combination with Topical Administration of Tranexamic Acid for Management of Postpartum Hemorrhage

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    Masato Kinugasa

    2015-01-01

    Full Text Available While uterine balloon tamponade is an effective modality for control of postpartum hemorrhage, the reported success rates have ranged from the level of 60% to the level of 80%. In unsuccessful cases, more invasive interventions are needed, including hysterectomy as a last resort. We developed a modified tamponade method and applied it to two cases of refractory postpartum hemorrhage after vaginal delivery. The first case was accompanied by uterine myoma and low-lying placenta. After an induced delivery, the patient had excessive hemorrhage due to uterine atony. Despite oxytocin infusion and bimanual uterine compression, the total blood loss was estimated at 2,800 mL or more. The second case was diagnosed as placental abruption complicated by fetal death and severe disseminated intravascular coagulation, subsequently. A profuse hemorrhage continued despite administration of uterotonics, fluid, and blood transfusion. The total blood loss was more than 5,000 mL. In each case, an intrauterine balloon catheter was wrapped in gauze impregnated with tranexamic acid, inserted into the uterus, and inflated sufficiently with sterile water. In this way, mechanical compression by a balloon and a topical antifibrinolytic agent were combined together. This method brought complete hemostasis and no further treatments were needed. Both the women left hospital in stable condition.

  18. Tranexamic Acid in the Treatment of Melasma: A Review of the Literature.

    Science.gov (United States)

    Perper, Marina; Eber, Ariel Eva; Fayne, Rachel; Verne, Sebastian Hugo; Magno, Robert James; Cervantes, Jessica; ALharbi, Mana; ALOmair, Ibrahim; Alfuraih, Abdulkarem; Nouri, Keyvan

    2017-03-10

    Melasma is a common acquired pigmentary disorder marked by irregular hyperpigmented macules or patches and most commonly occurs in women of darker skin color. It is a chronic often-relapsing condition that causes negative psychosocial effects in those affected. Current treatments such as hydroquinone, kojic acid, and retinoids, among others, demonstrate variable efficacy and side-effect profiles. We conducted a comprehensive literature review examining the use of tranexamic acid (TA), a well-known anti-fibrinolytic agent, in the treatment of melasma. TA delivered orally, topically, and through physical methods works via the inhibition of ultraviolet (UV)-induced plasmin activity in keratinocytes. Predefined search terms were entered into PubMed. Articles were then independently screened by two authors to include only those written in the English language and relating to human subjects with at least mild melasma. The search identified 28 articles, 15 of which met the criteria for full review. The review revealed that TA treatment for melasma is equally effective or more effective than other standard therapies and may induce fewer side effects. Our comprehensive review suggests that TA may be a promising treatment option for melasma because of its demonstrated effectiveness alone and in combination with other modalities as well as its limited side-effect profile.

  19. Inadvertent intrathecal injection of tranexamic acid

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    Olfa Kaabachi

    2011-01-01

    Full Text Available Some factors have been identified as contributing to medical errors such as labels, appearance, and location of ampules. In this case report, inadvertent intrathecal injection of 80 mg tranexamic acid was followed by severe pain in the back and the gluteal region, myoclonus on lower extremities and agitation. General anesthesia was induced to complete surgery. At the end of anesthesia, patient developed polymyoclonus and seizures needing supportive care of the hemodynamic, and respiratory systems. He developed ventricular tachycardia treated with Cordarone infusion. The patient′s condition progressively improved to full recovery 2 days after. Confusion between hyperbaric bupivacaine and tranexamic acid was due to similarities in appearance between both ampules.

  20. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery.

    Science.gov (United States)

    Lin, Zilan X; Woolf, Shane K

    2016-01-01

    Perioperative bleeding and postsurgical hemorrhage are common in invasive surgical procedures, including orthopedic surgery. Tranexamic acid (TXA) is a pharmacologic agent that acts through an antifibrinolytic mechanism to stabilize formed clots and reduce active bleeding. It has been used successfully in orthopedics to reduce perioperative blood loss, particularly in total hip and knee arthroplasty and spine surgery. Numerous research studies have reported favorable safety and efficacy in orthopedic cases, although there is no universal standard on its administration and its use has not yet become the standard of practice. Reported administration methods often depend on the surgeon's preference, with both topical and intravenous routes showing efficacy. The type and anatomic site of the surgery seem to influence the decision making but also result in conflicting opinions. Reported complication rates with TXA use are low. The incidence of both arterial and venous thromboembolic events, particularly deep venous thrombosis and pulmonary embolism, has not been found to be significantly different with TXA use for healthy patients. The route of administration and dosage do not appear to affect complication rates either. However, data on patients with higher-risk conditions are deficient. In addition, TXA has shown potential to reduce blood loss, transfusion rates and volumes, perioperative hemoglobin change, and hospital-related costs at various degrees among the published studies. Conservation of blood products, reduced laboratory costs, and shorter hospital stays are likely the major factors driving the cost savings associated with TXA use. This article reviews current data supporting the safety, efficacy, and cost-effectiveness of TXA in orthopedic surgery.

  1. Topical tranexamic acid as a promising treatment for melasma

    Science.gov (United States)

    Ebrahimi, Bahareh; Naeini, Farahnaz Fatemi

    2014-01-01

    Background: In recent times, tranexamic acid (TA) is claimed to have whitening effects especially for ultraviolet-induced hyperpigmentation including melasma. The aim of our study was to evaluate the efficacy and safety of topical solution of TA and compare it with combined solution of hydroquinone and dexamethasone as the gold standard treatment of melasma in Iranian women. Materials and Methods: This was a double-blind split-face trial of 12 weeks which was conducted in Isfahan, Iran. Fifty Iranian melasma patients applied topical solution of 3% TA on one side of the face, and topical solution of 3% hydroquinone + 0.01% dexamethasone on the other side two times a day. The Melasma Area and Severity Index (MASI) and the side effects were evaluated at baseline and every 4 weeks before and after photographs to be compared by a dermatologist were taken. The patient satisfaction was documented at week 12. Results: A repeated measurement analysis was used to evaluate the changes in the MASI score before and after treatments. A significant decreasing trend was observed in the MASI score of both groups with no significant difference between them during the study (P < 0.05). No differences were seen in patients’ and investigator's satisfaction of melasma improvement between two groups (P < 0.05). However, the side effects of hydroquinone + dexamethasone were significantly prominent compared with TA (P = 0.01). Conclusion: This study's results introduce the topical TA as an effective and safe medication for the treatment of melasma. PMID:25422661

  2. An international based survey on perioperative use of tranexamic acid in neurotrauma

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    Moscote-Salazar Luis Rafael

    2016-06-01

    Full Text Available Background: Tranexamic acid is used to reduce bleeding, easy to use, affordable and relatively safe. There are few studies on the use of tranexamic acid in trauma and especially in neurosurgery. There is no published study on the trend the use of tranexamic acid in neurotrauma surgery among international doctors. The aim of this study was to evaluate the current practice for use of tranexamic acid during neurotrauma surgery.

  3. Spectrophotometric determination of tranexamic acid using vanillin

    Institute of Scientific and Technical Information of China (English)

    EM.A.Rind; M.G.H.Laghari; A.H.Memon; U.R.Mughal; F. Almani; N.Me-mon; M.Y.Khuhawar; M.L.Maheshwari

    2009-01-01

    A new spectrophotometric method has been examined for the determination of the tranexamic acid (TA)by derivatization with vanillin(VAN).The molar absorptivity of TA was calculated 25 160 L·mol-1·cm-1at λ max 354 nm and obeyed the Beer's law within 0.5-2.5 μg·mL-1.The color reaction was highly stable and didnot show any change in absorbance up to 24 h.The method was applied for the analysis of TA from capsules,injections and tooth pastes.The amounts of TA found in capsules,injections and tooth pastes of various pharmaceutical companies were observed with 249.0-250.9 mg/capsule,249.3-250.7 mg/injection and 0.048%-0.049%in tooth pastes with relative standard deviation(RSD)0.2%-5.0%(n=3).

  4. The amelioration effect of tranexamic acid in wrinkles induced by skin dryness.

    Science.gov (United States)

    Hiramoto, Keiichi; Sugiyama, Daijiro; Takahashi, Yumi; Mafune, Eiichi

    2016-05-01

    Tranexamic acid (trans-4-aminomethylcyclohexanecarboxylic acid) is a medical amino acid widely used as an anti-inflammatory and a whitening agent. This study examined the effect of tranexamic acid administration in wrinkle formation following skin dryness. We administered tranexamic acid (750mg/kg/day) orally for 20 consecutive days to Naruto Research Institute Otsuka Atrichia (NOA) mice, which naturally develop skin dryness. In these NOA mice, deterioration of transepidermal water loss (TEWL), generation of wrinkles, decrease of collagen type I, and increases in mast cell proliferation and tryptase and matrix metalloproteinase (MMP-1) release were observed. However, these symptoms were improved by tranexamic acid treatment. Moreover, the increase in the β-endorphin level in the blood and the expression of μ-opioid receptor on the surface of fibroblasts increased by tranexamic acid treatment. In addition, when the fibroblasts induced by tranexamic acid treatment were removed, the amelioration effect by tranexamic acid treatment was halved. On the other hand, tranexamic acid treated NOA mice and mast cell removal in tranexamic acid treated NOA mice did not result in changes in the wrinkle amelioration effect. Additionally, the amelioration effect of mast cell deficient NOA mice was half that of tranexamic acid treated NOA mice. These results indicate that tranexamic acid decreased the proliferation of mast cells and increases the proliferation of fibroblasts, subsequently improving wrinkles caused by skin dryness.

  5. Combined Intra-Articular and Intravenous Tranexamic Acid Reduces Blood Loss in Total Knee Arthroplasty

    DEFF Research Database (Denmark)

    Nielsen, Christian Skovgaard; Jans, Øivind; Ørsnes, Thue;

    2016-01-01

    BACKGROUND: In total knee arthroplasty, both intravenous (IV) and intra-articular (IA) administration of tranexamic acid (TXA) have been shown to reduce blood loss in several randomized controlled trials, although routine use of systemic TXA is considerably more common. However, to our knowledge......-only administration of TXA. METHODS: In this randomized, double-blind, placebo-controlled trial, 60 patients scheduled for total knee arthroplasty were randomized to one of two interventions. The TXA IV and IA group received combined administration of TXA consisting of 1 g administered intravenously preoperatively......, the additional benefit of IA administration of TXA when combined with IV administration, without the use of a tourniquet, has not been previously investigated. Thus, the aim of this study was to evaluate whether combined IV and IA administration of TXA reduced total blood loss compared with IV...

  6. Topical tranexamic acid as a promising treatment for melasma

    Directory of Open Access Journals (Sweden)

    Bahareh Ebrahimi

    2014-01-01

    Full Text Available Background: In recent times, tranexamic acid (TA is claimed to have whitening effects especially for ultraviolet-induced hyperpigmentation including melasma. The aim of our study was to evaluate the efficacy and safety of topical solution of TA and compare it with combined solution of hydroquinone and dexamethasone as the gold standard treatment of melasma in Iranian women. Materials and Methods: This was a double-blind split-face trial of 12 weeks which was conducted in Isfahan, Iran. Fifty Iranian melasma patients applied topical solution of 3% TA on one side of the face, and topical solution of 3% hydroquinone + 0.01% dexamethasone on the other side two times a day. The Melasma Area and Severity Index (MASI and the side effects were evaluated at baseline and every 4 weeks before and after photographs to be compared by a dermatologist were taken. The patient satisfaction was documented at week 12. Results: A repeated measurement analysis was used to evaluate the changes in the MASI score before and after treatments. A significant decreasing trend was observed in the MASI score of both groups with no significant difference between them during the study (P < 0.05. No differences were seen in patients′ and investigator′s satisfaction of melasma improvement between two groups (P < 0.05. However, the side effects of hydroquinone + dexamethasone were significantly prominent compared with TA (P = 0.01. Conclusion: This study′s results introduce the topical TA as an effective and safe medication for the treatment of melasma.

  7. Risk factors associated with postoperative seizures in patients undergoing cardiac surgery who received tranexamic acid: A case-control study

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    Felix R Montes

    2012-01-01

    Full Text Available Antifibrinolytic agents are used during cardiac surgery to minimize bleeding and reduce exposure to blood products. Several reports suggest that tranexamic acid (TA can induce seizure activity in the postoperative period. To examine factors associated with postoperative seizures in patients undergoing cardiac surgery who received TA. University-affiliated hospital. Case-control study. Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB between January 2008 and December 2009 were identified. During this time, all patients undergoing heart surgery with CPB received TA. Cases were defined as patients who developed seizures that required initiation of anticonvulsive therapy within 48 h of surgery. Exclusion criteria included subjects with preexisting epilepsy and patients in whom the convulsive episode was secondary to a new ischemic lesion on brain imaging. Controls who did not develop seizures were randomly selected from the initial cohort. From an initial cohort of 903 patients, we identified 32 patients with postoperative seizures. Four patients were excluded. Twenty-eight cases and 112 controls were analyzed. Cases were more likely to have a history of renal impairment and higher preoperative creatinine values compared with controls (1.39 ± 1.1 vs. 0.98 ± 0.02 mg/dL, P = 0.02. Significant differences in the intensive care unit, postoperative and total lengths of stay were observed. An association between high preoperative creatinine value and postoperative seizure was identified. TA may be associated with the development of postoperative seizures in patients with renal dysfunction. Doses of TA should be reduced or even avoided in this population.

  8. Tranexamic acid for upper gastrointestinal bleeding

    DEFF Research Database (Denmark)

    Bennett, Cathy; Klingenberg, Sarah Louise; Langholz, Ebbe;

    2014-01-01

    controlled trial from which data are not yet available. Control groups were randomly assigned to placebo (seven trials) or no intervention (one trial). Two trials also included a control group randomly assigned to antiulcer drugs(lansoprazole or cimetidine). The included studies were published from 1973...

  9. Maternal malaria induces a procoagulant and antifibrinolytic state that is embryotoxic but responsive to anticoagulant therapy.

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    John W Avery

    Full Text Available Low birth weight and fetal loss are commonly attributed to malaria in endemic areas, but the cellular and molecular mechanisms that underlie these poor birth outcomes are incompletely understood. Increasing evidence suggests that dysregulated hemostasis is important in malaria pathogenesis, but its role in placental malaria (PM, characterized by intervillous sequestration of Plasmodium falciparum, proinflammatory responses, and excessive fibrin deposition is not known. To address this question, markers of coagulation and fibrinolysis were assessed in placentae from malaria-exposed primigravid women. PM was associated with significantly elevated placental monocyte and proinflammatory marker levels, enhanced perivillous fibrin deposition, and increased markers of activated coagulation and suppressed fibrinolysis in placental plasma. Submicroscopic PM was not proinflammatory but tended to be procoagulant and antifibrinolytic. Birth weight trended downward in association with placental parasitemia and high fibrin score. To directly assess the importance of coagulation in malaria-induced compromise of pregnancy, Plasmodium chabaudi AS-infected pregnant C57BL/6 mice were treated with the anticoagulant, low molecular weight heparin. Treatment rescued pregnancy at midgestation, with substantially decreased rates of active abortion and reduced placental and embryonic hemorrhage and necrosis relative to untreated animals. Together, the results suggest that dysregulated hemostasis may represent a novel therapeutic target in malaria-compromised pregnancies.

  10. Tranexamic Acid Mechanisms and Pharmacokinetics in Traumatic Injury

    Science.gov (United States)

    2015-10-01

    patients with severe traumatic injury will determine if the use of tranexamic acid within 2 hours of injury is associated with less immune suppression...forms”, contact information for the study team, links to our Facebook and Twitter pages, feedback forms, our community power point presentation, and...4308 Nearest person month worked 1 Contribution to Project: Dr. Fuchs has developed and validated laboratory techniques associated with the

  11. A questionnaire-based survey investigating the current use of tranexamic acid in traumatic haemorrhage and elective hip and knee arthroplasty

    Science.gov (United States)

    Moondi, Parvez

    2014-01-01

    Objectives To record the current use of tranexamic acid during traumatic haemorrhage and elective arthroplasty of the hip and knee. Design A questionnaire-based postal survey. Setting The questionnaire was sent to the ‘anaesthetic lead’ at all acute trusts in England, excluding centres for children, women’s health, cancer and cardiac care. Participants Ninety-nine (66%) centres replied to the questionnaire. Main outcome measures Is tranexamic acid used as part of routine standardized treatment for traumatic haemorrhage and for elective hip and knee arthroplasty, and if so what dosage regime was administered? Results Few trusts (31%) use tranexamic acid during traumatic haemorrhage, with various dosages used. Its use in hip and knee arthroplasty was also low (38%) with a diverse range of doses prescribed. Conclusions Despite many trials showing its efficacy and low risk of side effect, it is clear that its use is not part of standard practice in most centres. Further studies could clarify these concerns and provide a definitive dosing schedule improving patient care and saving lives. PMID:25057371

  12. Is prophylactic tranexamic acid administration effective and safe for postpartum hemorrhage prevention?

    Science.gov (United States)

    Li, Chunbo; Gong, Yuping; Dong, Lingling; Xie, Bingying; Dai, Zhiyuan

    2017-01-01

    Abstract Background: To assess the efficacy and safety of tranexamic acid (TA) in reducing blood loss and lowering transfusion needs for patients undergoing caesarean section (CS) or vaginal delivery (VD). Methods: An electronic literature search of PubMed, EMBASE, OVID, Cochrane library, Scopus, Central, and Clinical trials.gov was performed to identify studies that evaluating the usage of TA in CS or VD. The methodological quality of included trials was assessed and data extraction was performed. Results: Finally, 25 articles with 4747 participants were included. Our findings indicated TA resulted in a reduced intra-, postoperative, and total blood loss by a mean volume of 141.25 mL (95% confidence interval [CI] −186.72 to −95.79, P DVT) after CS or VD was associated with TA usage, while the minor side effects were more common. Conclusions: Our findings indicated that intravenous TA for patients undergoing CS was effective and safe. Although prophylactic TA administration is associated with reduced PPH, current existing data are insufficient to draw definitive recommendations about its clinical significance due to the poor to moderate quality of the included literatures. Thus, high-quality randomized controlled trials with larger samples are needed to validate our findings. PMID:28072700

  13. Angiotensin-converting enzyme inhibitors attenuate propofol-induced pro-oxidative and antifibrinolytic effect in human endothelial cells

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    Marzena Wojewodzka-Zelezniakowicz

    2017-01-01

    Full Text Available Introduction: The aim of this study was to investigate the effects of plasma and tissue angiotensin-converting enzyme inhibitors (ACE-Is against propofol-induced endothelial dysfunction and to elucidate the involved mechanisms in vitro. Materials and methods: We examined the effects of propofol (50 μM, quinaprilat and enalaprilat (10−5 M on fibrinolysis (t-PA, PAI-1, TAFI antigen levels, oxidative stress parameters (H2O2 and MDA antigen levels and SOD and NADPH oxidase mRNA levels and nitric oxide bioavailability (NO2/NO3 concentration and NOS expression at the level of mRNA in human umbilical vein endothelial cells (HUVECs. Results: We found that both ACE-Is promoted similar endothelial fibrinolytic properties and decreased oxidative stress in vitro. Propofol alone increased the release of antifibrinolytic and pro-oxidative factors from the endothelium and increased mRNA iNOS expression. We also found that the incubation of HUVECs in the presence of propofol following ACE-Is pre-incubation caused weakness of the antifibrinolytic and pro-oxidative potential of propofol and this effect was similar after both ACE-Is. Conclusions: This observation suggests that the studied ACE-Is exerted protective effects against endothelial cell dysfunction caused by propofol, independently of hemodynamics.

  14. Effects of tranexamic acid during endoscopic sinsus surgery in children

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    Ahmed A Eldaba

    2013-01-01

    Full Text Available Objectives: This study was conducted to evaluate the effect of tranexamic acid (TA on the intra-operative bleeding during the functional endoscopic sinus surgery (FESS in children. Methods: A total of 100 children recruited to undergo FESS were randomized into two groups. Group I: Was given just after induction, intra-venous 25 mg/kg TA diluted in 10 ml of normal saline. Group II: Was given 10 ml of normal saline. Non-invasive blood pressure, heart rate, and quality of the surgical field were estimated every 15 min. Volume of bleeding and duration of the surgical procedure were recorded. Results: Surgical field quality after 15 min revealed that seven patients in group I had minimal bleeding versus no one in group II, P=0.006. Meanwhile, 35 patients in group I had mild bleeding versus 26 patients in group II, P=0.064. Higher number of patients in group II than in group I had moderate bleeding, P=0006. Also, at 30 min, revealed that 10 patients in group I had minimal bleeding versus one patient in group II, P=0.004. Meanwhile, 37 patients in group I had mild bleeding versus 28 patients in group II, P=0.059. Higher number of patients in group II than in group I had moderate bleeding, P<0001. Duration of the surgeries and volume of bleeding were significantly less in tranexamic group than the placebo group, P<0.0001. Conclusion: Single intra-venous bolus dose of tranexamic in children during the FESS improves quality of surgical field, reduces intra-operative bleeding, and duration of surgery.

  15. Telangiectasia hemorrágica hereditária: ácido tranexâmico no tratamento de úlcera plantar Hereditary hemorrhagic telangiectasia: tranexamic acid for plantar ulcer

    Directory of Open Access Journals (Sweden)

    Gabriella Corrêa de Albuquerque

    2005-12-01

    Full Text Available Relato de um caso de úlcera plantar por fístula arteriovenosa em paciente portador de telangiectasia hemorrágica hereditária ou doença de Rendu-Osler-Weber tratado com ácido tranexâmico. Este fármaco é utilizado para tratamento de epistaxe, referindo-se o principal achado deste artigo ao uso eficaz desse medicamento na terapia de úlceras plantares hemorrágicas. São descritos os aspectos fisiopatológicos e clínicos da doença e as propriedades antifibrinolíticas do ácido tranexâmico. Este foi bem tolerado e apresentou evidências de eficácia na utilização para controle do sangramento e cicatrização da úlcera.Case report of one patient with Hereditary Hemorrhagic Telangiectasia, also known as Rendu-Osler-Weber syndrome, treated with Tranexamic Acid for arteriovenous plantar ulcer. This drug has proved effective in controlling epistaxis, but the main point of this report is to expose the success use of this medication in the therapy of skin bleeding ulcer. The pathophysiologic and clinical features of the disease are reviewed and also the pharmacological aspects of the antifibrinolytic drugs. This drug was well tolerated by the patient and show evidence of good activity in the bleeding and healed the ulcer.

  16. Tranexamic Acid (TXA) in Trauma Patients: Barriers to Use among Trauma Surgeons and Emergency Physicians

    Science.gov (United States)

    2017-01-01

    Objective. Tranexamic Acid (TXA) is currently the only drug with prospective clinical evidence supporting its use in bleeding trauma patients. We sought to better understand the barriers preventing its use and elicit suggestions to further its use in trauma patients in the state of Maryland. Methods. This is a cross-sectional study. Results. The overall response rate was 38%. Half of all participants reported being familiar with the CRASH-2 trial and MATTERs study. Half reported being aware of TXA as part of their institution's massive transfusion protocol. The majority of participants felt that TXA would have a significant positive impact on the survival of trauma patients. A majority also felt that the use of TXA would increase if its administration was the responsibility of both trauma surgeons and emergency physicians. Conclusion. Only half of responders reported being aware of TXA as being part of their institution's massive transfusion protocol. Lack of awareness of the clinical data supporting its use is a major barrier. However, most trauma providers and emergency physicians do have a favorable view of TXA and support its incorporation into massive transfusion protocols. We believe that more studies of this kind on both state and national level are needed.

  17. A randomised, open-label, comparative study of tranexamic acid microinjections and tranexamic acid with microneedling in patients with melasma

    Directory of Open Access Journals (Sweden)

    Leelavathy Budamakuntla

    2013-01-01

    Full Text Available Background: Melasma is a common cause of facial hyperpigmentation with significant cosmetic deformity. Although several treatment modalities are available, none is satisfactory. Aim: To compare the therapeutic efficacy and safety of tranexamic acid (TA microinjections versus tranexamic acid with microneedling in melasma. Materials and Methods: This is a prospective, randomised, open-label study with a sample size of 60; 30 in each treatment arms. Thirty patients were administered with localised microinjections of TA in one arm, and other 30 with TA with microneedling. The procedure was done at monthly intervals (0, 4 and 8 weeks and followed up for three consecutive months. Clinical images were taken at each visit including modified Melasma Area Severity Index MASI scoring, patient global assessment and physician global assessment to assess the clinical response. Results: In the microinjection group, there was 35.72% improvement in the MASI score compared to 44.41% in the microneedling group, at the end of third follow-up visit. Six patients (26.09% in the microinjections group, as compared to 12 patients (41.38% in the microneedling group, showed more than 50% improvement. However, there were no major adverse events observed in both the treatment groups. Conclusions: On the basis of these results, TA can be used as potentially a new, effective, safe and promising therapeutic agent in melasma. The medication is easily available and affordable. Better therapeutic response to treatment in the microneedling group could be attributed to the deeper and uniform delivery of the medication through microchannels created by microneedling.

  18. A Randomised, Open-label, Comparative Study of Tranexamic Acid Microinjections and Tranexamic Acid with Microneedling in Patients with Melasma

    Science.gov (United States)

    Budamakuntla, Leelavathy; Loganathan, Eswari; Suresh, Deepak Hurkudli; Shanmugam, Sharavana; Suryanarayan, Shwetha; Dongare, Aparna; Venkataramiah, Lakshmi Dammaningala; Prabhu, Namitha

    2013-01-01

    Background: Melasma is a common cause of facial hyperpigmentation with significant cosmetic deformity. Although several treatment modalities are available, none is satisfactory. Aim: To compare the therapeutic efficacy and safety of tranexamic acid (TA) microinjections versus tranexamic acid with microneedling in melasma. Materials and Methods: This is a prospective, randomised, open-label study with a sample size of 60; 30 in each treatment arms. Thirty patients were administered with localised microinjections of TA in one arm, and other 30 with TA with microneedling. The procedure was done at monthly intervals (0, 4 and 8 weeks) and followed up for three consecutive months. Clinical images were taken at each visit including modified Melasma Area Severity Index MASI scoring, patient global assessment and physician global assessment to assess the clinical response. Results: In the microinjection group, there was 35.72% improvement in the MASI score compared to 44.41% in the microneedling group, at the end of third follow-up visit. Six patients (26.09%) in the microinjections group, as compared to 12 patients (41.38%) in the microneedling group, showed more than 50% improvement. However, there were no major adverse events observed in both the treatment groups. Conclusions: On the basis of these results, TA can be used as potentially a new, effective, safe and promising therapeutic agent in melasma. The medication is easily available and affordable. Better therapeutic response to treatment in the microneedling group could be attributed to the deeper and uniform delivery of the medication through microchannels created by microneedling. PMID:24163529

  19. Comparison of tranexamic acid (Transamin and traditional therapy for sudden deafness.

    Directory of Open Access Journals (Sweden)

    Ohsaki,Katsuichiro

    1980-11-01

    Full Text Available The effectiveness of tranexamic acid treatment for sudden deafness was studied in detail. The results of treatment with tranexamic acid administration in 19 cases (25 ears of sudden deafness and two historical control groups using various treatments were compared by the chi square contingency test. The data suggested that tranexamic acid treatment may be superior to traditional treatments especially if treatment is begun early. Among ears treated with tranexamic acid, 11 ears (44% were healed or recovered remarkably, 8 ears (32% recovered slightly and 6 ears (24% were unchanged or worsened. Fibrinolysis in the inner ear may be the pathophysiology of sudden deafness. Treatment with tranexamic acid starting within 4 days after onset of symptoms was most effective in patients whose initial audiogram was flat or concave, initial average hearing loss at 5 frequencies (250 Hz, 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz was between 23 dB and 76 dB (mean; 45.1 dB and was not accompanied by dizziness.

  20. The effectiveness and safety of tranexamic acid in bilateral total knee arthroplasty

    Science.gov (United States)

    Weng, Kedi; Zhang, Xingen; Bi, Qing; Zhao, Chen

    2016-01-01

    Abstract Objective: A meta-analysis was performed to investigate the effectiveness and safety of tranexamic acid (TXA) for the treatment of blood loss after a bilateral total knee arthroplasty (TKA). Methods: Patients prepared for bilateral TKA and intervention including TXA versus placebo were comprehensively retrieved from MEDLINE (PubMed), Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science from the time of the establishment of these databases to January 2016. The outcomes were all calculated by Stata 12.0 software. The continuous endpoints (total blood loss and blood loss in drainage) were calculated as mean difference (MD) and 95% confidence intervals (CIs). Binary variables (the need for transfusion, and the occurrence of deep venous thrombosis [DVT]) were calculated as relative risk (RR) with 95% CIs. Results: Pooled results revealed that treatment with TXA associated with less need for transfusion (P = 0.000) and the value of Hb drop postoperatively (P = 0.290) after bilateral TKA. The results also indicated that TXA can decrease the total blood loss and blood loss in drainage after bilateral TKA (P < 0.05). Meanwhile, TXA can decrease the blood units transfused per patient by 1.23 U (P = 0.001). There is no statistically significant difference in terms of the occurrence of DVT between the 2 groups (P = 0.461). Conclusion: Based on the current evidence, TXA can decrease the need for transfusion and the total blood loss without increasing the occurrence of DVT, and its administration is recommended routinely in bilateral TKA. PMID:27684841

  1. Use of tranexamic acid in total knee arthroplasty

    Science.gov (United States)

    MARRA, FRANCESCO; ROSSO, FEDERICA; BRUZZONE, MATTEO; BONASIA, DAVIDE EDOARDO; DETTONI, FEDERICO; ROSSI, ROBERTO

    2016-01-01

    Purpose different strategies have been developed to reduce blood loss in total knee arthroplasty (TKA). The efficacy of both systemic and local tranexamic acid (TXA) administration is demonstrated in the literature. The aim of the present study was to compare the efficacy of systemic, local and combined (systemic + local) administration of TXA in reducing blood loss after TKA. Methods we enrolled all patients submitted to a primary TKA in our department between November 2014 and August 2015. They were divided into three groups corresponding to the method of TXA administration used: intravenous (IV), intra-articular (IA), and a combination of the two. Demographic data, as well as preoperative hemoglobin and platelet levels, were collected. The primary outcome was the maximum hemoglobin loss, while the secondary outcomes were the amount of blood in the drain (cc/hour) and the rate of transfusions; postoperative pain was also assessed. Student’s t-test or a χ2 test was used to evaluate between-group differences, using ptotal blood loss in TKA, and no administration protocol seems to be superior to the others. Level of evidence Level II, prospective comparative study. PMID:28217656

  2. Prevention of Bleeding in Orthognathic Surgery--A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    DEFF Research Database (Denmark)

    Olsen, Jesper J; Skov, Jane; Ingerslev, Janne

    2016-01-01

    and operating time. This review is registered at PROSPERO (CRD42014014840). RESULTS: Eleven trials were included for review. The individual trials demonstrated the effects on IOB from hypotensive anesthetic regimens, the use of aprotinin, and the herbal medicine Yunnan Baiyao. Six studies of tranexamic acid...

  3. Tranexamic acid reduces blood loss in patients with extracapsular fractures of the hip

    DEFF Research Database (Denmark)

    Tengberg, P T; Foss, N B; Palm, H;

    2016-01-01

    AIMS: We chose unstable extra-capsular hip fractures as our study group because these types of fractures suffer the largest blood loss. We hypothesised that tranexamic acid (TXA) would reduce total blood loss (TBL) in extra-capsular fractures of the hip. PATIENTS AND METHODS: A single-centre plac...

  4. Low Risk of Thromboembolic Events After Routine Administration of Tranexamic Acid in Hip and Knee Arthroplasty

    DEFF Research Database (Denmark)

    Madsen, Rune V; Nielsen, Christian S; Kallemose, Thomas;

    2016-01-01

    BACKGROUND: The blood-conserving effect of intravenous (IV) tranexamic acid (TXA) is well-documented for total hip arthroplasty (THA) and total knee arthroplasty (TKA). However, the risk of thromboembolic (TE) events after routine use of TXA is unclear and the safety profile is debated. This retr...

  5. Role of tranexamic acid in reducing blood loss during and after caesarean section

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    Simran Kaur Bhatia

    2015-01-01

    Full Text Available Introduction: Association between caesarean section and intra operative and post operative bleeding is known. Post-partum hemorrhage is still a leading cause for maternal morbidity and mortality. This study will evaluate the efficacy and safety of tranexamic acid in reducing the blood loss after placental delivery following lower segment caesarean section (LSCS and note any adverse effects. Materials and Methods: A total of 100 women, who underwent elective or emergency primary caesarean section at term between 37 and 41 weeks have been studied prospectively. They were divided into two groups. In the study group of 50, tranexamic acid 1 gm IV was given 20 minutes before making incision for caesarean section and the control group of 50 did not receive tranexamic acid. Statistical Analysis: For quantitative outcomes, the t-test was used to test for difference in the two groups. For categorical outcomes, chi square and odds ratio with 95% confidence interval were used as applicable. Results: The patient characteristics, namely age, height, weight, gestational age and gravidity in two groups were similar which was statistically insignificant. Hemoglobin decreased slightly after birth in both groups but no statistical difference between two groups was noticed. There was no episode of thrombosis in the study. Tranexamic acid significantly reduced the quantity of the blood loss from time of placental delivery to 2 hours postpartum (P < 0.001 and from end of LSCS to 2 hours postpartum (P < 0.001. However, there was no statistical difference in quantity of blood loss from time of placental delivery to end of LSCS in both groups (P < 0.001. Conclusion: A safe dose of tranexamic acid has an effective role in reducing blood loss during LSCS without causing adverse reaction. Thus, drug can be used effectively in reducing maternal morbidity and mortality during LSCS.

  6. Which Route of Tranexamic Acid Administration is More Effective to Reduce Blood Loss Following Total Knee Arthroplasty?

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    Sohrab Keyhani

    2016-01-01

    Full Text Available Background: The most appropriate route of tranexamic acid administration is controversial. In the current study, we compared the efficacy of intravenous (IV and topical intra-articular tranexamic acid in reducing blood loss and transfusion rate in patients who underwent primary total knee arthroplasty. Methods: One hundred twenty 120 patients were scheduled to undergo primary total knee arthroplasty. Patients were randomly allocated to three equal groups: IV tranexamic acid (500 mg, topical tranexamic acid (3 g in 100 mL normal saline and the control. In the topical group, half of the volume was used to irrigate the joint and the other half was injected intra-articularly. The volume of blood loss, hemoglobin (Hb level at 24 hours postoperative, and rate of transfusion was compared between groups. Results: The blood loss and Hb level were significantly greater and lower in the control group, respectively (P

  7. Study of Tranexamic Acid During Air Medical Prehospital Transport Trial (STAAMP trial)

    Science.gov (United States)

    2015-10-01

    Jason L. Sperry, M.D., MPH CONTRACTING ORGANIZATION: University of Pittsburgh, Pittsburgh, PA 15213 REPORT DATE: October 2015 TYPE OF REPORT...or modified tasks, objectives, experiments, etc.) requires review by the Grants Officer’s Representative and final approval by USAMRAA Grants Officer...that have contributed to the major goals and objectives and that have potential impact on the research field. - Pittsburgh site began enrollment

  8. How Is Hemophilia Treated?

    Science.gov (United States)

    ... prior to dental work or before playing certain sports to prevent or reduce bleeding. Antifibrinolytic Medicines Antifibrinolytic medicines (including tranexamic acid and epsilon aminocaproic acid) may be used with replacement therapy. They're usually given as a pill, and ...

  9. Efficiency and Safety of Intravenous Tranexamic Acid in Simultaneous Bilateral Total Knee Arthroplasty: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Jiang, Xuan; Ma, Xin-Long; Ma, Jian-Xiong

    2016-08-01

    The objective of this systematic review and meta-analysis was to evaluate the efficacy and safety of i.v. tranexamic acid (TXA) in simultaneous bilateral total knee arthroplasty (TKA). Potentially relevant published reports were identified from the following electronic databases: Medline, PubMed, Embase, ScienceDirect and Cochrane Library. RevMan v5.3was used to pool data. Two randomized controlled trials and four case-control studies met the inclusion criteria. The current meta-analysis identified significant differences between TXA group and control groups in terms of postoperative hemoglobin concentration (P < 0.01), drainage volume (P < 0.01), transfusion rate (P < 0.01) and units transfused (P = 0.006). There were no significant differences in length of stay (P = 0.66), operation time (P = 0.81) or and incidence of adverse effects such as infection (P = 0.42), deep venous thrombosis (DVT) (P = 0.88) and pulmonary embolism (PE) (P = 0.11). Our results show that i.v. administration of TXA in simultaneous bilateral TKA reduces postoperative drops in hemoglobin concentration, drainage volume, and transfusion requirements and does not prolong length of stay or operation time. Moreover, no adverse effects, such as infection, DVT or PE, were associated with TXA.

  10. The Value of Tranexamic Acid in Reducing Blood Loss following Hip Reconstruction in Children with Cerebral Palsy

    Science.gov (United States)

    Majid, I.; Alshryda, S.; Somanchi, B.; Morakis, E.; Foster, A.

    2015-01-01

    This is a retrospective study of 51 consecutive hip reconstructions in children with cerebral palsy performed between 2011 and 2013. Tranexamic acid (TXA) was used in 14 hip reconstructions only. Transfusion rate was higher, postoperative Hb was lower, and patients stayed longer in the TXA group. This did not reach a statistical significance (P = 0.75, 0.5, and 0.71, resp.). More than half of the patients who had TXA underwent bilateral hip reconstructions in comparison with 27% only in the non-TXA group. Bilateral hip reconstructions mean more surgery, more blood loss, and more blood transfusion. The patients who had TXA were significantly more disabled as evident by the higher proportions of patient with worse GMFCS levels. Although we have not been able to demonstrate the value of TXA in reducing blood loss and transfusion rate in children with CP who underwent hip reconstruction, it is hoped that an interest in exploring the value of TXA in paediatric orthopaedic surgery is generated. Ideally this should be explored further in an adequately powered, randomised controlled trial where risk of bias is minimized. PMID:26664830

  11. The Value of Tranexamic Acid in Reducing Blood Loss following Hip Reconstruction in Children with Cerebral Palsy

    Directory of Open Access Journals (Sweden)

    I. Majid

    2015-01-01

    Full Text Available This is a retrospective study of 51 consecutive hip reconstructions in children with cerebral palsy performed between 2011 and 2013. Tranexamic acid (TXA was used in 14 hip reconstructions only. Transfusion rate was higher, postoperative Hb was lower, and patients stayed longer in the TXA group. This did not reach a statistical significance (P = 0.75, 0.5, and 0.71, resp.. More than half of the patients who had TXA underwent bilateral hip reconstructions in comparison with 27% only in the non-TXA group. Bilateral hip reconstructions mean more surgery, more blood loss, and more blood transfusion. The patients who had TXA were significantly more disabled as evident by the higher proportions of patient with worse GMFCS levels. Although we have not been able to demonstrate the value of TXA in reducing blood loss and transfusion rate in children with CP who underwent hip reconstruction, it is hoped that an interest in exploring the value of TXA in paediatric orthopaedic surgery is generated. Ideally this should be explored further in an adequately powered, randomised controlled trial where risk of bias is minimized.

  12. Clamping drainage is unnecessary after minimally invasive total knee arthroplasty in patients with tranexamic acid

    Science.gov (United States)

    Wu, Yuangang; Yang, Timin; Zeng, Yi; Li, Canfeng; Shen, Bin; Pei, Fuxing

    2017-01-01

    Abstract Background: Drainage and tranexamic acid (TXA) have been widely used in total knee arthroplasty (TKA). However, it remains unclear whether it is necessary to clamp the drain after minimally invasive TKA (MIS-TKA) when TXA is used. We therefore conducted a randomized controlled trial to compare the effects of clamping versus not clamping drainage following MIS-TKA in patients in whom TXA was used. Methods: From January 2015 to December 2015, 121 patients undergoing unilateral primary MIS-TKA were enrolled and randomly divided into 2 groups. In the clamping group (N = 60), drainage was clamped for the 1st 4 postoperative hours. In the nonclamping group (N = 61), drainage was not clamped. All patients underwent a minimidvastus approach and received 10 mg/kg TXA intravenously before tourniquet deflation. We recorded the total blood loss, drainage volume, and transfusion requirements in the postoperative period. We also measured the hemoglobin (Hb) and hematocrit (Hct) levels on postoperative days 1, 3, and 5. Other factors, including range of motion (ROM), visual analog scale (VAS), and occurrence of wound-related complications, deep vein thrombosis (DVT), and pulmonary embolism (PE) were recorded at the time of discharge and 1 and 6 months postoperatively. No statistically significant differences were found between the 2 groups with regard to age, gender, weight, BMI, preoperative Hb and Hct levels, preoperative ROM, VAS, duration of surgery, anesthesia method, and the American Society of Anesthesiologists classification. Results: The clamping group experienced better drainage volume results than the nonclamping group (P < 0.001). There were no statistically significant differences in TBL and transfusion requirements (P = 0.105 and 0.276, respectively); Hb and Hct levels on postoperative days 1, 3, and 5 were similar between the 2 groups. No significant differences were found for ROM, VAS, DVT, PE, wound-related complications, and hospital

  13. Comparison of treatment effects between animal experiments and clinical trials: systematic review

    OpenAIRE

    2006-01-01

    Objective To examine concordance between treatment effects in animal experiments and clinical trials.Study design Systematic review.Data sources Medline, Embase, SIGLE, NTIS, Science Citation Index, CAB, BIOSIS.Study selection Animal studies for interventions with unambiguous evidence of a treatment effect (benefit or harm) in clinical trials: head injury, antifibrinolytics in haemorrhage, thrombolysis in acute ischaemic stroke, tirilazad in acute ischaemic stroke, antenatal corticosteroids t...

  14. EFFICACY OF TRANEXAMIC ACID IN DECREASING BLOOD LOSS DURING AND AFTER CAESAREAN SECTION: A RANDOMIZED CASE CONTROL PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Tullika

    2014-03-01

    Full Text Available : INTRODUCTION: To reduce maternal mortality and morbidity caused by bleeding, it is important to reduce the amount of bleeding during and after lower segment caesarean section (LSCS. Tranexamic acid helps to reduce bleeding during and after LSCS. OBJECTIVES: To study the efficacy and safety of Tranexamic acid in reducing blood loss during and after Lower segment Caesarean Section (LSCS. METHODS: A randomized case controlled prospective study was conducted on 200 women undergoing lower segment cesarean section. Hundreds of them that were given tranexamic acid immediately before LSCS were compared to hundred others to whom tranexamic acid was not given. Blood loss was collected and measured during the two periods, from plancental delivery to end of LSCS and second from end of LSCS to two hours postpartum. RESULTS: Tranexamic acid significantly reduced the quantity of blood loss from placental delivery to end of LSCS, 202.25ml in the study group vs392.20 ml in the control group (p<0.001; from the end of LSCS, to 2 hours postpartum 3.80ml in the study group versus 112.25ml in the control group (p<0.001; In totality, it significantly reduced the quantity of blood loss from placental delivery to two hours postpartum i.e. 27.05ml in the study group versus 510.45ml in the control group (p < 0.001. No complications or side effects were noted. CONCLUSION: Tranexamic acid significantly reduced the amount of blood loss during and after LSCS. Tranexamic acid can be used prophylactically; moreover it is safer and effective in women undergoing LSCS.

  15. Tranexamic Acid and Trauma: Current Status and Knowledge Gaps with Recommended Research Priorities

    Science.gov (United States)

    2013-01-01

    Trauma 65:300Y308, 2008. 16. Ekeh AP, Dominguez KM, Markert RJ, McCarthy MC: Incidence and risk factors for deep venous thrombosis after moderate and...the impact of tranexamic acid and other risk factors . Can J Anaesth 59:6Y13, 2012. 22. Koster A, Börgermann J, Zittermann A, Lueth JU, Gillis...mortality were observed. As is common for retrospective database analyses, there were some confounding factors , including a change in clinical practice

  16. Comparing efficacy and safety of 2 methods of tranexamic acid administration in reducing blood loss following total knee arthroplasty

    Science.gov (United States)

    Fu, Yu; Shi, Zhigang; Han, Bing; Ye, Yong; You, Tao; Jing, Juehua; Li, Jun

    2016-01-01

    Abstract Background: The purpose of this systematic review and meta-analysis of randomized controlled trials (RCTs) were to gather data to evaluate the efficacy and safety of topical tranexamic acid (TXA) versus intravenous (IV) TXA for blood loss after a total knee arthroplasty (TKA). Methods: Electronic databases: Pubmed, Web of Science, Cochrane library, and Embase from inception to June 2016 were searched. RCTs that comparing topical with IV TXA for blood loss control in patients prepared for TKA were included in this meta-analysis. The Cochrane risk of bias tool was used to appraise risk of bias. The primary outcomes were needed for transfusion, total blood loss, and blood loss in drainage. Secondary outcomes are hemoglobin (Hb) value at 24-hour post TKA and complication (deep venous thrombosis [DVT] and infection). The efficacy of blood loss was tested by total blood loss, drainage volume, Hb drop, and the Hb value at 24 hours after TKA. The safety was measured by the occurrence of DVT and infection. Continuous outcomes were expressed as the mean difference with the respective 95% confidence intervals (CIs). Discontinuous outcomes were expressed as the relative risk with 95% CIs. Stata 12.0 software (Stata Corp., College Station, TX) was used for the meta-analysis. Results: A total of 14 articles involving 1390 patients were finally included for this meta-analysis. The pooled results revealed that there were no significant difference between the need for transfusion, total blood loss, blood loss in drainage, Hb value at 24-hour post TKA, the occurrence of complications (infection and DVT) between topical administration of TXA and IV TXA. Conclusion: Topical TXA has similar efficacy for blood loss control to IV TXA without sacrificing safety in TKA. However, the dose of topical TXA and IV TXA is different, thus, optimal timing and dose of TXA are still needed to explore the maximum effect of TXA. PMID:27977593

  17. Combination Intravenous and Intra-Articular Tranexamic acid compared with Intravenous Only Administration and No Therapy in Total Knee Arthroplasty: A Case Series Study

    Directory of Open Access Journals (Sweden)

    Chris Buntting

    2016-07-01

    This study supports the existing literature and suggests that the use of IV Tranexamic acid alone or in combination with intra-articular dose in TKA may reduce the requirement for transfusion (Level IV evidence. Furthermore, this study suggests that the use of tranexamic acid as a combination of Intravenous and intra-articular administration has no effect on range of motion, or medical complications during hospital stay. Although it was not a statistically significant finding, our study suggested a trend towards a greater reduction in haemoglobin and haematocrit fall in the combination therapy group when compared to IV Tranexamic acid alone

  18. Tranexamic Acid Decreases Incidence of Blood Transfusion in Simultaneous Bilateral Total Knee Arthroplasty.

    Science.gov (United States)

    Bagsby, Deren T; Samujh, Christopher A; Vissing, Jacqueline L; Empson, Janene A; Pomeroy, Donald L; Malkani, Arthur L

    2015-12-01

    Blood management for simultaneous bilateral total knee arthroplasty (TKA) patients is more challenging than in unilateral arthroplasty. We examined if administration of tranexamic acid (TXA) to patients undergoing simultaneous bilateral TKA would reduce blood loss and decrease allogeneic blood transfusion requirements. A retrospective review of 103 patients, 57 in the control and 46 in the TXA group, was performed. There was higher postoperative day 1 hemoglobin in patients receiving TXA (2.95±1.33 versus 4.33±1.19, Ptransfusion incidence with administration of TXA (17.4% versus 57.9%, Ptransfusion rates by almost 70% in simultaneous bilateral total knee arthroplasty.

  19. Sex differences regarding the amelioration of wrinkles due to skin dryness by the administration of tranexamic acid.

    Science.gov (United States)

    Hiramoto, Keiichi; Sugiyama, Daijiro; Iizuka, Yasutaka; Yamaguchi, Tomohiko

    2016-10-01

    Tranexamic acid (trans-4-aminomethylcyclohexanecarboxylic acid) exerts an amelioration effect on wrinkle formation due to skin dryness. We examined the sex differences in this effect. We administered tranexamic acid (750mg/kg/day) orally for 20 consecutive days to male and female Naruto Research Institute Otsuka Atrichia (NOA) mice, which naturally develop skin dryness. In the treated female mice, the amelioration effect on the wrinkle score, deterioration of transepidermal water loss (TEWL), capacitance, and decrease in the expression of collagen type I was stronger than in the male treated mice. Furthermore, the level of β-endorphin in the plasma and the expression of β-endorphin, μ-opioid receptor, and macrophages in the dorsal skin increased after the administration of tranexamic acid, and this increase was higher in female mice than in males. In addition, the macrophage production was increased by the administration of tranexamic acid in the ovary but did not change after administration in the testes. A histological examination revealed that these macrophages produce the β-endorphin, clarifying the source of the elevated levels. The amelioration effect in the female treated mice was decreased by the administration of clophosome (a macrophage inhibitor) to a degree that did not markedly differ from the effect observed in the male treated mice. These results suggest that the amelioration effect on wrinkles is stronger in female NOA mice than in males and that β-endorphin produced by macrophages plays an important role in this sex difference.

  20. Tranexamic acid, an inhibitor of plasminogen activation, reduces urinary collagen cross-link excretion in both experimental and rheumatoid arthritis

    NARCIS (Netherlands)

    Ronday, H.K.; TeKoppele, J.M.; Greenwald, R.A.; Moak, S.A.; Roos, J.A.D.M. de; Dijkmans, B.A.C.; Breedveld, F.C.; Verheijen, J.H.

    1998-01-01

    The plasminogen activation system is one of the enzyme systems held responsible for bone and cartilage degradation in rheumatoid arthritis (RA). In this study, we evaluated the effect of tranexamic acid (TEA), an inhibitor of plasminogen activation, on urinary collagen cross-link excretion and radio

  1. A systematic review and meta-analysis of the effect of prophylactic tranexamic acid treatment in major benign uterine surgery

    DEFF Research Database (Denmark)

    Topsoee, Märta F; Settnes, Annette; Ottesen, Bent;

    2017-01-01

    BACKGROUND: The value of tranexamic acid (TA) treatment as bleeding prophylaxis in major uterine surgery is unclear. OBJECTIVES: To evaluate the antihemorrhagic effect of prophylactic TA treatment in major benign uterine surgery. SEARCH STRATEGY: PubMed, Embase, Cochrane Library, and Web of Science...

  2. Pregabalin and Tranexamic Acid Evaluation by Two Simple and Sensitive Spectrophotometric Methods

    Science.gov (United States)

    Sher, Nawab; Fatima, Nasreen; Perveen, Shahnaz; Siddiqui, Farhan Ahmed; Wafa Sial, Alisha

    2015-01-01

    This paper demonstrates colorimetric visible spectrophotometric quantification methods for amino acid, namely, tranexamic acid and pregabalin. Both drugs contain the amino group, and when they are reacted with 2,4-dinitrophenol and 2,4,6-trinitrophenol, they give rise to yellow colored complexes showing absorption maximum at 418 nm and 425 nm, respectively, based on the Lewis acid base reaction. Detailed optimization process and stoichiometric studies were conducted along with investigation of thermodynamic features, that is, association constant and standard free energy changes. The method was linear over the concentration range of 0.02–200 µgmL−1 with correlation coefficient of more than 0.9990 in all of the cases. Limit of detection was in range from 0.0041 to 0.0094 µgmL−1 and limit of quantification was in the range from 0.0137 to 0.0302 µgmL−1. Excellent recovery in Placebo spiked samples indicated that there is no interference from common excipients. The analytical methods under proposal were successfully applied to determine tranexamic acid and pregabalin in commercial products. t-test and F ratio were evaluated without noticeable difference between the proposed and reference methods. PMID:25873964

  3. Pregabalin and Tranexamic Acid Evaluation by Two Simple and Sensitive Spectrophotometric Methods

    Directory of Open Access Journals (Sweden)

    Nawab Sher

    2015-01-01

    Full Text Available This paper demonstrates colorimetric visible spectrophotometric quantification methods for amino acid, namely, tranexamic acid and pregabalin. Both drugs contain the amino group, and when they are reacted with 2,4-dinitrophenol and 2,4,6-trinitrophenol, they give rise to yellow colored complexes showing absorption maximum at 418 nm and 425 nm, respectively, based on the Lewis acid base reaction. Detailed optimization process and stoichiometric studies were conducted along with investigation of thermodynamic features, that is, association constant and standard free energy changes. The method was linear over the concentration range of 0.02–200 µgmL−1 with correlation coefficient of more than 0.9990 in all of the cases. Limit of detection was in range from 0.0041 to 0.0094 µgmL−1 and limit of quantification was in the range from 0.0137 to 0.0302 µgmL−1. Excellent recovery in Placebo spiked samples indicated that there is no interference from common excipients. The analytical methods under proposal were successfully applied to determine tranexamic acid and pregabalin in commercial products. t-test and F ratio were evaluated without noticeable difference between the proposed and reference methods.

  4. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  5. Tranexamic acid reduces the blood loss and blood transfusion requirements following peri-acetabular osteotomy.

    Science.gov (United States)

    Wassilew, G I; Perka, C; Janz, V; Krämer, M; Renner, L

    2015-12-01

    We have investigated the effect of using tranexamic acid (TXA) during peri-acetabular osteotomy (PAO) on peri-operative blood loss and blood transfusion requirements. In addition we analysed whether the use of TXA was associated with an increased risk of venous thromboembolism (VTE) following this procedure. A consecutive series of 96 PAOs, performed by a single surgeon, were reviewed. A total of 48 patients received TXA and 48 did not. The TXA group received a continuous infusion of TXA at a rate of 10 mg/kg/h. The primary outcome measure was the requirement for blood transfusion. Secondary outcomes included total blood loss, the decrease in the level of haemoglobin in the blood, the length of hospital stay, and the complications of this treatment. The mean rate of transfusion was significantly lower in the TXA group (62.5% vs 12.5%, p transfusion after PAO significantly, without adverse effects such as an increased rate of VTE.

  6. Tranexamic acid in treatment of melasma: A comprehensive review of clinical studies.

    Science.gov (United States)

    Taraz, Mohammad; Niknam, Somayeh; Ehsani, Amir Houshang

    2017-01-30

    Melasma is a human melanogenesis dysfunction that results in localized, chronic acquired hyperpigmentation of the skin. It has a significant impact on appearance, causing psychosocial and emotional distress, and reducing the quality of life of the affected patients. Tranexamic acid (TA) is a plasmin inhibitor used to prevent abnormal fibrinolysis to reduce blood loss and exerts its effect by reversibly blocking lysine binding sites on plasminogen molecules, thus inhibiting plasminogen activator (PA) from converting plasminogen to plasmin. As plasminogen also exists in human epidermal basal cells and cultured human keratinocyte are known to produce PA, there is basic rationale that TA will affect keratinocyte function and interaction. A thorough literature review indicates that while TA is used through various route of administration including oral, topical, and intradermal injection and as adjutant therapy with laser to treat melasma, its efficacy is not established adequately. Further studies are needed to clarify the role of TA in treatment of melasma.

  7. Intravenous 1 gram tranexamic acid for prevention of blood loss and blood transfusion during caesarean section: a randomized case control study

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    Babita Ramani

    2014-04-01

    Full Text Available Background: Aim of current study was to determine the effect of tranexamic acid in reducing blood loss during and after C-section. Methods: All women undergoing LSCS were divided in two groups viz study and control group. All were requested for pre-op and post-op Hb%, PCV and TRBC. Intravenous tranexamic acid one gm was given to study group (not to control group 10 min prior to skin incision and blood loss in both groups was calculated by weighing prewieghed pads soaked in blood. Results: Post-op blood loss was significantly lower in study group (P = 0.020. Hb% changes in post-op period is significant in control group (P = 0.037. Conclusions: Tranexamic acid is safe and effective in preventing post-partum hemorrhage after caesarean section. [Int J Reprod Contracept Obstet Gynecol 2014; 3(2.000: 366-369

  8. Effect of tranexamic acid on blood loss and transfusion requirement in total knee replacement in the Indian population: A case series

    Science.gov (United States)

    Gautam, Parshotam Lal; Katyal, Sunil; Yamin, Mohammad; Singh, Amandip

    2011-01-01

    Context: Total knee replacement (TKR) is often carried out using a tourniquet to minimize intraoperative blood loss. However, its application enhances local fibrinolysis, resulting in excessive blood loss during the post-operative period. Fibrinolytic profile varies in different regions and races. Tranexamic acid has been shown to reduce post-operative blood loss and the need for transfusion in TKR. However, there is paucity of literature from the Indian population and the efficacy of the agent has not been tested in Indian patients undergoing TKR. Aims: Effect of tranexamic acid on blood loss in TKR surgery in the Indian population. Setting and Design: In this double-blinded study, 40 patients undergoing unilateral TKR were randomly divided into two groups. Methods: All patients were conducted under spinal anaesthesia using injection bupivacaine 0.5% heavy 12-15 mg. The treatment group received 10 mg/kg tranexamic acid, intravenous (IV), half an hour before deflation of the tourniquet, with a second dose of 2 mg/kg administered 3 hours after the first dose. The exact protocol was followed for the placebo group, except that normal saline was used instead of tranexamic acid. Blood loss, blood transfusion details and change in haemoglobin levels were noted. Statistical Analysis: Student's paired ‘t’ test was used in statistical analysis. Results: The mean post-operative blood loss in the tranexamic acid group was 272.5±122.5 ml (mean±SD), and 685±118.2 ml in the placebo group (P<0.001). The total blood loss was lower in the tranexamic acid group than in the placebo group (427.6 ml vs. 911.6 ml; P<0.001). The absolute number of blood transfusions and the number of patients who required transfusions were lower in the tranexamic acid group than in the placebo group. None of the patients had any side or adverse effect. Conclusions: Tranexamic acid significantly decreases post-operative blood loss and reduces the need for blood transfusion in patients undergoing

  9. Effect of tranexamic acid on blood loss and transfusion requirement in total knee replacement in the Indian population: A case series

    Directory of Open Access Journals (Sweden)

    Parshotam Lal Gautam

    2011-01-01

    Full Text Available Context: Total knee replacement (TKR is often carried out using a tourniquet to minimize intraoperative blood loss. However, its application enhances local fibrinolysis, resulting in excessive blood loss during the post-operative period. Fibrinolytic profile varies in different regions and races. Tranexamic acid has been shown to reduce post-operative blood loss and the need for transfusion in TKR. However, there is paucity of literature from the Indian population and the efficacy of the agent has not been tested in Indian patients undergoing TKR. Aims: Effect of tranexamic acid on blood loss in TKR surgery in the Indian population. Setting and Design: In this double-blinded study, 40 patients undergoing unilateral TKR were randomly divided into two groups. Methods: All patients were conducted under spinal anaesthesia using injection bupivacaine 0.5% heavy 12-15 mg. The treatment group received 10 mg/kg tranexamic acid, intravenous (IV, half an hour before deflation of the tourniquet, with a second dose of 2 mg/kg administered 3 hours after the first dose. The exact protocol was followed for the placebo group, except that normal saline was used instead of tranexamic acid. Blood loss, blood transfusion details and change in haemoglobin levels were noted. Statistical Analysis: Student′s paired ′t′ test was used in statistical analysis. Results: The mean post-operative blood loss in the tranexamic acid group was 272.5±122.5 ml (mean±SD, and 685±118.2 ml in the placebo group (P<0.001. The total blood loss was lower in the tranexamic acid group than in the placebo group (427.6 ml vs. 911.6 ml; P<0.001. The absolute number of blood transfusions and the number of patients who required transfusions were lower in the tranexamic acid group than in the placebo group. None of the patients had any side or adverse effect. Conclusions: Tranexamic acid significantly decreases post-operative blood loss and reduces the need for blood transfusion in

  10. 氨甲环酸用于全髋关节置换有效性与安全性的Meta分析%Efficacy and safety of tranexamic acid application in total hip arthroplasty:a meta-analysis

    Institute of Scientific and Technical Information of China (English)

    刘丙根; 庞清江

    2014-01-01

    BACKGROUND:Whether tranexamic acid can effectively and safely reduce blood loss and al ogeneic transfusion rate in total hip arthroplasty remains controversial at present. OBJECTIVE:To assess the efficacy and safety of tranexamic acid administration in total hip arthroplasty using meta-analysis. METHODS:Clinical randomized control ed trials concerning tranexamic acid application in total hip arthroplasty published from January 1969 to December 2013 were retrieved from the PubMed, Ovid, Elsevier, Cochrane library, China National Knowledge Infrastructure and Wanfang database. Intraoperative blood loss, postoperative blood loss, total blood loss, al ogeneic transfusion rate and incidence of venous thromboembolism were compared using meta-analysis between the tranexamic acid and control groups. Detection and literature references were used as supplementary data. RevMan 5.0 software provided by Cochrane col aboration was used for meta-analyses. Conclusion was obtained according to analysis. The analysis checked the heterogeneity of data. RESULTS AND CONCLUSION:After comprehensive and rigorous screening, 19 high-quality (Jadad score not less than 3) randomized control ed studies were included. Meta-analysis results demonstrated that compared with the control group, tranexamic acid decreased the total blood loss [weighted mean difference (WMD)=-341.04, 95%confidence interval (CI) (-508.10,-173.97), P<0.001], intraoperative blood loss [WMD=-63.26, 95%CI (-111.33,-15.18), P=0.01] and postoperative blood loss [WMD=-229.53, 95%CI (-338.11,-120.94), P<0.000 1], and diminished al ogeneic transfusion rate [relative risk=0.45, 95%CI (0.35, 0.57), P<0.000 1] in patients undergoing total hip arthroplasty. No significant difference in incidence of venous thromboembolism was detectable. These data suggested that tranexamic acid could reduce blood loss and transfusion rate in patients undergoing total hip arthroplasty without increasing the risk of incidence of venous thromboembolism

  11. EFFECT OF TRANEXAMIC ACID ON BLEEDING CONTROL IN TOTAL KNEE ARTHROPLASTY

    Science.gov (United States)

    SADIGURSKY, DAVID; ANDION, DANIEL; BOUREAU, PÉRICLES; FERREIRA, MARIA CORDULINA; CARNEIRO, ROGÉRIO JAMIL FERNANDES; COLAVOLPE, PAULO OLIVEIRA

    2016-01-01

    ABSTRACT Objectives: To analyze the effectiveness of intravenous (IV) tranexamic acid (TA) in reducing blood loss in total knee arthroplasty (TKA). Method: The population sample was composed of patients with a diagnosis of primary knee osteoarthritis. The patients undergoing TKA were divided in two groups. Group A: comprised patients who used IV TA and B group, formed by patients who did not use TA in the intra or post-operative period. For descriptive analysis, quantitative variables were represented by mean and standard deviations when their distribution was normal and interquartile ranges and medians for non-normal variables. Results: The mean age of patients was 68 years old, most of them were female and with involvement of the left knee. Postoperatively patients who had used IV TA showed less bleeding rate and less hemoglobin rate reduction. Conclusion: The use of IV TA in TKA reduces blood loss in peri- and postoperative periods. Regarding total blood loss reduction, hemoglobin rate and need for blood transfusions, IV TA should be used routinely during TKA since it has been shown to be safe with no increase in side effects as thromboembolic events. Level of Evidence III. Retrospective Comparative Study. PMID:27217813

  12. The effect of aprotinin, tranexamic acid, and aminocaproic acid on blood loss and use of blood products in major pediatric surgery : A meta-analysis

    NARCIS (Netherlands)

    Schouten, Esther S.; van de Pol, Alma C.; Schouten, Anton N. J.; Turner, Nigel M.; Jansen, Nicolaas J. G.; Bollen, Casper W.

    2009-01-01

    Objective: Aprotinin reduces the blood loss and transfusion of blood products in children undergoing major surgery. Aprotinin has been associated with severe side effects in adults, and tranexamic acid and aminocaproic acid have been found to be safer alternatives in adults. This systematic review a

  13. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients

    DEFF Research Database (Denmark)

    Husted, Henrik; Blønd, Lars; Sonne-Holm, Stig;

    2003-01-01

    INTRODUCTION: We performed a prospective, randomized, double-blind study on 40 patients scheduled for primary total hip arthroplasty due to arthrosis or osteonecrosis to determine the effect of tranexamic acid on per- and postoperative blood losses and on the number of blood transfusions needed...

  14. Does tranexamic acid stabilised fibrin support the osteogenic differentiation of human periosteum derived cells?

    Directory of Open Access Journals (Sweden)

    J Demol

    2011-03-01

    Full Text Available Fibrin sealants have long been used as carrier for osteogenic cells in bone regeneration. However, it has not been demonstrated whether fibrin’s role is limited to delivering cells to the bone defect or whether fibrin enhances osteogenesis. This study investigated fibrin’s influence on the behaviour of human periosteum-derived cells (hPDCs when cultured in vitro under osteogenic conditions in two-dimensional (fibrin substrate and three-dimensional (fibrin carrier environments. Tranexamic acid (TEA was used to reduce fibrin degradation after investigating its effect on hPDCs in monolayer culture on plastic.TEA did not affect proliferation nor calcium deposition of hPDCs under these conditions. Expression profiles of specific osteogenic markers were also maintained within the presence of TEA, apart from reduced alkaline phosphatase (ALP expression (day 14. Compared to plastic, proliferation was upregulated on 2D fibrin substrates with a 220% higher DNA content by day 21. Gene expression was also altered, with significantly (p<0.05 decreased Runx2 (day 7 and ALP (day 14 expression and increased collagen I expression (day 14 and 21. In contrast to plastic, mineralisation was absent on fibrin substrates. Inside fibrin carriers, hPDCs were uniformly distributed. Moderate cell growth and reduced osteogenic marker expression was observed inside fibrin carriers. After 2 weeks, increased cell death was present in the carrier’s centre. In conclusion, fibrin negatively influences osteogenic differentiation, compared to culture plastic, but enhanced proliferation (at least in 2D cultures for hPDCs cultured in osteogenic conditions. TEA maintained the integrity of fibrin-based constructs, with minor effects on the osteogenic differentiation of hPDCs.

  15. Giving tranexamic acid to reduce surgical bleeding in sub-Saharan Africa: an economic evaluation

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    Perel Pablo

    2010-02-01

    Full Text Available Abstract Background The identification of safe and effective alternatives to blood transfusion is a public health priority. In sub-Saharan Africa, blood shortage is a cause of mortality and morbidity. Blood transfusion can also transmit viral infections. Giving tranexamic acid (TXA to bleeding surgical patients has been shown to reduce both the number of blood transfusions and the volume of blood transfused. The objective of this study is to investigate whether routinely administering TXA to bleeding elective surgical patients is cost effective by both averting deaths occurring from the shortage of blood, and by preventing infections from blood transfusions. Methods A decision tree was constructed to evaluate the cost-effectiveness of providing TXA compared with no TXA in patients with surgical bleeding in four African countries with different human immunodeficiency virus (HIV prevalence and blood donation rates (Kenya, South Africa, Tanzania and Botswana. The principal outcome measures were cost per life saved and cost per infection averted (HIV, Hepatitis B, Hepatitis C averted in 2007 International dollars ($. The probability of receiving a blood transfusion with and without TXA and the risk of blood borne viral infection were estimated. The impact of uncertainty in model parameters was explored using one-way deterministic sensitivity analyses. Probabilistic sensitivity analysis was performed using Monte Carlo simulation. Results The incremental cost per life saved is $87 for Kenya and $93 for Tanzania. In Botswana and South Africa, TXA administration is not life saving but is highly cost saving since fewer units of blood are transfused. Further, in Botswana the administration of TXA averts one case of HIV and four cases of Hepatitis B (HBV per 1,000 surgical patients. In South Africa, one case of HBV is averted per 1,000 surgical patients. Probabilistic sensitivity analyses confirmed the robustness of the model. Conclusion An economic

  16. Tranexamic acid combined with recombinant factor VIII increases clot resistance to accelerated fibrinolysis in severe hemophilia A

    DEFF Research Database (Denmark)

    Hvas, Anne-Mette; Sørensen, Hanne Thykjær; Norengaard, Lisbeth

    2007-01-01

    BACKGROUND: Most patients with severe hemophilia A suffer from a profoundly compromised hemostatic response. In addition to both the delayed and slow development of a clot, previous studies have documented that severe hemophilia A is also associated with reduced clot stability. OBJECTIVES: We...... examined whether the clot stability in hemophiliacs could be improved by treatment with tranexamic acid (TXA) in combination with recombinant factor VIII (rFVIII). PATIENTS/METHODS: Baseline blood samples were obtained from eight males with severe hemophilia A. Thereafter, a bolus injection of r...... the elasticity curve increased 5-fold after rFVIII and 24-fold after addition of TXA. CONCLUSIONS: The study demonstrates that simultaneous treatment with TXA and rFVIII significantly improves the clot stability in patients with hemophilia A. Udgivelsesdato: December...

  17. ROLE OF TRANEXAMIC ACID IN REDUCING POSTOPERATIVE BLOOD LOSS AND TRANSFUSION REQUIREMENT IN PATIENTS UNDERGOING LOWER LIMB ORTHOPEDIC SURGERIES

    Directory of Open Access Journals (Sweden)

    Yashwant

    2014-09-01

    Full Text Available AIM: Aim of our study to assess the effects of tranexamic acid (TA in patients undergoing lower limb orthopedic surgeries. OBJECTIVE: Assess the effects of tranexamic acid on prevention of bleeding and requirement of blood transfusion after major lower limb orthopedic surgeries. MATERIAL AND METHOD: 90 patients ASA grade I & II undergoing elective surgery for femoral fracture like open reduction internal fixation, hemiarthroplasty, total hip replacement (THR under anaesthesia were taken. Patients were classified randomly into 2 groups (forty five patients in each group. Group T: Patients received inj. TA 10 mg/kg body weight. Group P: Patients received normal saline 1 ml/kg body weight 15 min before surgery. Postoperative hemoglobin concentration (on day 0 and day 2 and volume of blood in the drain were measured. The number of units of packed red cells transfused during the hospital stay was recorded and any thromboembolic and other complications were documented. RESULT: Analysis revealed that there were no significant differences between the patients with respect to age, sex, duration and type of surgery and preoperative mean hemoglobin concentration. Neither heart rate nor MABP has statistically significant difference or results (P>0.05. The drains were removed in the evening of the first postoperative day. Mean volume of blood in the drain compared to placebo group showing a highly significant reduction in postoperative blood loss (P=0.01. Mean fall in hemoglobin at day 0 and day 2 was 2 less in the study group as compared to the placebo that has P value 0.01 making it significant finding. CONCLUSION: the present paired study demonstrated that the administration of TA given preoperatively reduces the blood loss in the first 24 h by a highly significant degree as well it causes a significant reduction in postoperative anemia and need for transfusion among these patients.

  18. 抗纤溶治疗对急性早幼粒细胞白血病合并DIC患者脏器功能影响的研究%Analysis of effect of antifibrinolytic therapy on organ function of acute promyelocytic leukemia patients with DIC

    Institute of Scientific and Technical Information of China (English)

    袁凯锋; 唐君灵; 张建; 王建英

    2012-01-01

      目的:探讨抗纤溶治疗对急性早幼粒细胞白血病(APL)合并弥漫性血管内凝血(DIC)患者脏器功能的影响.方法:将满足入选标准的21例APL合并DIC患者采用自身前后对照研究的方法进行研究,均给予全反式维A酸(ATRA)诱导分化治疗,同时给予0.9%NS 250ml+止血芳酸3.0g ivgtt抗纤溶治疗,观察抗纤溶治疗1周对患者肝功、肾功、呼吸频率的影响.结果:抗纤溶治疗前后,满足入选标准的APL合并DIC患者的ALT、总胆红素、血肌酐和呼吸频率经配对t检验比较P值均>0.20,差异没有统计学意义,提示抗纤溶治疗对这类患者肝肾功能和呼吸频率影响没有差异.结论:APL合并DIC患者,在存在明显纤溶亢进的条件下,抗纤溶治疗对这类患者脏器功能的影响并不明显.%  Objective: To evaluate the effect of antifibrinolytic therapy on organ function of acute promyelocytic leukemia patients with DIC. Methods:21 cases of acute promyelocytic leukemia with DIC who met the test standard were given all-trans-retinoic A acid (ATRA) for inducing differentiation therapy, at the same time, for antifibrinolytic therapy,0.9% NS 250ml + aminomethylbenzoic acid 3.0g ivgtt qd were given. After one week, the effects of antifibrinolytic therapy on liver function, renal function, and respiratory rate were observed. Results:Before and after the antifibrinolytic therapy, the ALT, total bilirubin, serum creatinine, and respiratory rate of acute promyelocytic leukemia patients with DIC had no significant difference(P>0.20). Conclusion: When the condition of the significant hyperfibrinolysis existed, antifibrinolytic therapy has no obvious effect on organ function of acute promyelocytic leukemia patients with DIC.

  19. Co-drug strategy for promoting skin targeting and minimizing the transdermal diffusion of hydroquinone and tranexamic acid.

    Science.gov (United States)

    Hsieh, Pei-Wen; Chen, Wei-Yu; Aljuffali, Ibrahim A; Chen, Chun-Che; Fang, Jia-You

    2013-01-01

    Hydroquinone and tranexamic acids (TXA) are skin-lightening agents with a hydrophilic nature and low skin absorption. A high dose is needed for clinical use, resulting in a high incidence of skin irritation. Co-drugs formed by conjugating hydroquinone and TXA were synthesized and their in vitro and in vivo skin absorption characteristics were evaluated. The two synthesized co-drugs were 4-hydroxyphenyl 4-(aminomethyl)cyclohexanecarboxylate (HAC) and 1,4- phenylene bis(aminomethyl)cyclohexanecarboxylate (BAC). The co-drugs were chemically stable in aqueous solution, but rapidly degraded to the respective parent drug in esterases and skin homogenates. Compared to hydroquinone application, 7.2- and 2.4-fold increments in the hydroquinone skin deposition were obtained with the in vitro application of HAC and BAC. HAC and BAC led to 3- and 2-fold enhancements of equivalent TXA deposition compared to TXA administration. The in vivo experiment showed a further enhancement of co-drugs compared to the in vitro setup. The transdermal penetration of co-drugs, especially BAC, was much lower than that of hydroquinone and TXA. This indicated high-level skin targeting by the co-drugs. HAC and BAC revealed strong affinities for the viable epidermis/dermis. Hair follicles are important reservoirs for co-drug delivery. Daily administration of co-drugs to the skin did not generate irritation for up to 7 days. Both co-drugs are superior candidates for treating skin hyperpigmentation.

  20. An In Vivo Study of Low-Dose Intra-Articular Tranexamic Acid Application with Prolonged Clamping Drain Method in Total Knee Replacement: Clinical Efficacy and Safety

    Directory of Open Access Journals (Sweden)

    Paphon Sa-ngasoongsong

    2015-01-01

    Full Text Available Background. Recently, combined intra-articular tranexamic acid (IA-TXA injection with clamping drain method showed efficacy for blood loss and transfusion reduction in total knee replacement (TKR. However, until now, none of previous studies revealed the effect of this technique on pharmacokinetics, coagulation, and fibrinolysis. Materials and Methods. An experimental study was conducted, during 2011-2012, in 30 patients undergoing unilateral TKR. Patients received IA-TXA application and then were allocated into six groups regarding clamping drain duration (2-, 4-, 6-, 8-, 10-, and 12-hours. Blood and drainage fluid were collected to measure tranexamic acid (TXA level and related coagulation and fibrinolytic markers. Postoperative complication was followed for one year. Results. There was no significant difference of serum TXA level at 2 hour and 24 hour among groups (p<0.05. Serum TXA level at time of clamp release was significantly different among groups with the highest level at 2 hour (p<0.0001. There was no significant difference of TXA level in drainage fluid, postoperative blood loss, blood transfusion, and postoperative complications (p<0.05.  Conclusions. Low-dose IA-TXA application in TKR with prolonged clamping drain method is a safe and effective blood conservative technique with only minimal systemic absorption and without significant increase in systemic absorption over time.

  1. Research and Progress of Tranexamic Acid in Total Knee Arthroplasty%全膝关节置换术中应用氨甲环酸的研究进展

    Institute of Scientific and Technical Information of China (English)

    乔浩然; 黄健

    2016-01-01

    Total knee arthroplasty (TKA) is usually associated with massive perioperative blood loss, and a large number of blood loss will seriously affect the patient’s postoperative rehabilitation and increase the ifnancial burden of patients. At present, a large num-ber of studies have conifrmed tranexamic acid (Tranexamic acid TXA) as a ifbrinolytic inhibitor can effectively reduce the knee joint replacement surgery during the blood loss and reduce the rate of allogeneic blood transfusion. However, the safety, best route of admin-istration, timing of administration and dosage of tranexamic acid are not uniifed in total knee arthroplasty, and the above problems are reviewed in this paper.%全膝关节置换术(total knee arthroplasty,TKA)通常会导致围手术期大量失血,这也将严重影响患者术后康复及增加患者经济负担。目前,已有大量研究证实氨甲环酸(Tranexamic acidTXA)作为一种纤溶抑制剂,能有效减少膝关节置换术围术期的失血量并降低术后异体输血率。但氨甲环酸在全膝关节置换术中的安全性,最佳给药途径、给药时机及给药剂量观点尚不统一,本文就对以上问题的相关研究加以综述。

  2. 心肺转流冠状动脉旁路移植术前持续服用硫酸氯吡格雷和阿司匹林的患者氨甲环酸应用的有效性和安全性%Effectiveness and safty of tranexamic acid in patients receiving on-pump coronary artery bypass grafting without clopidogrel and aspirin cessation

    Institute of Scientific and Technical Information of China (English)

    石佳; 王越夫; 薛庆华; 袁素; 王古岩; 李立环

    2013-01-01

    目的 评价心肺转流冠状动脉旁路移植术(CABG)术前持续服用硫酸氯吡格雷(氯吡格雷)和阿司匹林的患者氨甲环酸应用的有效性和安全性.方法 本研究为前瞻性随机对照临床研究,将110例接受择期心肺转流CABG且术前持续服用氯吡格雷和阿司匹林直至术前7d以内的患者,随机分入氨甲环酸组和标准治疗组.氨甲环酸组在麻醉诱导后给予负荷量10 mg/kg静脉滴注,继以维持量10mg· kg-1·h-1持续静脉泵入直至手术结束;标准治疗组给予等量生理盐水.主要终点评价指标为围手术期异体红细胞输注量,次要终点评价指标为术后出血量、大出血发生率、二次开胸止血率、异体红细胞输注率以及异体血浆和血小板的输注量和输注率.结果 氨甲环酸组和标准治疗组的围手术期异体红细胞输注量分别为4.0(7.5)单位和6.0(6.0)单位(W=1021,P<0.01).两组的术后引流量分别为930(750) ml和1210(910) ml(W=1042,P<0.01),大出血发生率分别为50.9%和76.4%(x2=7.70,P<0.01),二次开胸止血率分别为0和9.1%(x2=5.24,P=0.02);异体血浆输注量分别为400(600) ml和600 (650) ml(W=1072,P=0.01)、输注率分别为60.0%和85.5%(x2=8.98,P<0.01),异体血制品总输注率分别为85.5%和98.2%(x2 =5.93,P=0.01).围手术期病死率、并发症和不良事件的发生率两组没有差异.结论 在心肺转流CABG前持续服用氯吡格雷和阿司匹林的患者中,氨甲环酸可以减少术后出血和异体输血,未观察到不良反应.%Objective To evaluate the effectiveness and safty of tranexamic acid in patients receiving on-pump coronary artery bypass grafting (CABG) without clopidogrel and aspirin cessation.Methods The current study is a prospective,randomized and placebo-control trial.A total of 116 patients receiving selective on-pump CABG with their last ingestion of clopidogrle and aspirin within 7 days preoperatively were recruited.Despite 6

  3. Tranexamic Acid in a Multimodal Blood Loss Prevention Protocol to Decrease Blood Loss in Revision Total Knee Arthroplasty: A Cohort Study#

    Science.gov (United States)

    Ortega-Andreu, Miguel; Talavera, Gloria; Padilla-Eguiluz, Norma G.; Perez-Chrzanowska, Hanna; Figueredo-Galve, Reyes; Rodriguez-Merchán, Carlos E.; Gómez-Barrena, Enrique

    2016-01-01

    Purpose: To clarify if blood loss and transfusion requirements can be decreased in revision knee surgery through a multimodal blood loss approach with tranexamic acid (TXA) Patients and Methods: A retrospective study was designed in 87 knees (79 patients) that received a knee revision between 2007 and 2013. To avoid heterogeneity in the surgical technique, only revisions with one single implant system were included. A treatment series of 44 knees that received TXA and other techniques in a multimodal blood loss protocol was compared to a control series of 43 knees that received neither TXA nor the rest of the multimodal blood loss protocol. No differences in the complexity of surgeries or case severity were detected. Results: A significant decrease was observed from 58% transfusion rate in the control group to 5% in the treated group. The postoperative haemoglobin drop was also significantly different. Although the use of a blood loss prevention approach including TXA was the most relevant factor in the transfusion risk (OR=15), longer surgical time also associated an increased risk of transfusion (OR=1.15). Conclusion: This study supports the use of a two-dose intravenous TXA under a multimodal blood loss prevention approach in revision knee replacement with significant reduction in the transfusion rate, postoperative blood loss and haemoglobin drop. PMID:27708740

  4. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  5. Administration of tranexamic acid to patients undergoing surgery for adolescent idiopathic scoliosis evokes pain and increases the infusion rate of remifentanil during the surgery

    Science.gov (United States)

    Ohashi, Nobuko; Ohashi, Masayuki; Endo, Naoto; Kohno, Tatsuro

    2017-01-01

    Background We recently reported that tranexamic acid (TXA) evokes pain in rats by inhibiting γ-aminobutyric acid and glycine receptors on neurons in the spinal dorsal horn. Although TXA is commonly used to reduce perioperative blood loss during various surgeries, its potential to induce intraoperative nociception, thereby increasing the need for more analgesics during surgery, has not been investigated. Therefore, this study aimed to investigate whether TXA evokes pain and increases the need for a higher infusion rate of remifentanil in patients undergoing surgery for adolescent idiopathic scoliosis (AIS). Methods Data were collected from patients with AIS who underwent posterior spinal fusion surgery from January 2008 to December 2015. All surgical procedures were performed under total intravenous anesthesia with propofol and remifentanil, by the same team of orthopedic surgeons and anesthesiologists at a single institution. Patients in the TXA group were administered TXA (loading and maintenance doses, 1000 mg and 100 mg/h) whereas those in the control group were not. Our primary outcome was the infusion rate of the intraoperative opioid analgesic remifentanil. Results The final analysis was based on data collected from 33 and 30 patients in the control and TXA groups, respectively. No differences were observed in the demographic data or the hemodynamic parameters between the two groups of patients. In the TXA group, the durations of surgery and anesthesia were shorter, intravascular fluid volume and total blood loss were lower, and the doses of fentanyl and ketamine administered were higher than they were in the control group (P pain during the surgery. PMID:28282425

  6. 氨甲环酸在人工关节外科领域的应用%Application of tranexamic acid in artiifcial joint surgery

    Institute of Scientific and Technical Information of China (English)

    马金辉; 孙伟; 高福强; 王云亭; 李子荣

    2014-01-01

    Tranexamic acid ( TXA ) is economical and safe, with good hemostatic effects in joint surgery. The intravenous route is most commonly used. TXA can also be administrated orally or intra-articularly but not intrathecally or intra-cerebrally. Better hemostatic effects can be achieved both in spinal surgery and total hip arthroplasty ( THA ) with the use of TXA. TXA is generally injected intra-articularly in total knee arthroplasty ( TKA ) before the tourniquet was released and after the capsule was sutured. The patients who underwent TKA were divided into 2 groups, including one group receiving 1.5% TXA intra-articularly and the other group receiving 3.0% TXA intra-articularly. The postoperative blood loss volume was 1295 ml in the 1.5% TXA group, and 1208 ml in the 3.0% TXA group. Statistically signiifcant differences were observed between the 2 groups, and the patients receiving more TXA had less blood loss. Only the articular cavity is affected with the intra-articular administration of TXA. Such advantages as minimal systemic absorption, less intra-articular bleeding and reduced risk of deep venous thrombosis ( DVT ) and pulmonary embolism ( PE ) can be found with the intra-articular administration of TXA when compared with the intravenous administration. The intra-articular administration of TXA is superior to the intravenous administration. ( 1 ) Potential complications related to the intravenous administration of TXA can be avoided or decreased, particularly in high-risk patients, such as the patients with cardiovascular diseases, venous thromboembolism, renal dysfunction and so on. ( 2 ) The blood loss, blood transfusion and transfusion rate after TKA can be reduced with the intra-articular administration of TXA. TXA is contraindicated in the patients with a history of arterial or venous thrombosis, hematological system diseases, acute renal failure, seizures and/or hypersensitivity. Postoperative hemorrhage is caused by many factors, and the physicians

  7. Tranexamic Acid and Reduced Glutathione Clinical Observation of Treating Melasma%氨甲环酸联合还原型谷胱甘肽治疗黄褐斑的临床观察

    Institute of Scientific and Technical Information of China (English)

    陆海山; 郭剑; 陈智勇; 赵启明; 甘精兵; 周蓉蓉; 吴近芳

    2011-01-01

    [目的]观察氧甲环酸联合还原型谷胱甘肽治疗黄褐斑的临床疗效.[方法] 152例黄褐斑患者使用氧甲环酸联合还原型谷胱甘肽口服治疗.观察服药后的临床效果、疗效出现时间、不良反应等.[结果]治疗时间2~6个月,平均3.9个月.治疗后随访3个月,92.11%的患者色斑减轻;服药6个月后痊愈者13.16%、无效者7.89%;停药后色素重新加深及复发者12例,出现胃肠道反应5例,出现月经量减少4例,出现口腔溃疡1例,其余未发现其他明显的不良反应.[结论]氨甲环酸联合还原型谷胱甘肽治疗黄褐斑有较好效果,值得临床应用借鉴.%[Objective] Observation of tranexamic acid and reduced glutathione treatment of melasma the clinical efficacy. [Methods] One hundredand fifty-two patients with melasma were treated with oral administrationof tranexamic acid and reduced glutathione. A retrospective study was madeon the therapeutic effect and Side effects. [Results] The treatment period was 2-6 months (mean 3.9 months). The patients were followed for 3 monthsafter treatment. The total improvement rate was 92.11%. After 6 months'treatment , the percentages of patients who were curetl.or Invalided were13.16% and 7.89% respectively. 12 patients had recurrences. There were no obvious side effects of the treatment except 5 cases of gastrointestinalreaction,4 cases of reduced menstrual, 1 case of oral ulcers . [Conclusion] Tranexamic acid and reduced glutathione treatment of nw-lasma has goodeffect, worthy of clinical application and reference.

  8. 氨甲环酸局部压迫法治疗牙龈出血的临床评价%A Clinical Evaluation of Topical Application of Tranexamic Acid for the Treatment of Gingival Bleeding

    Institute of Scientific and Technical Information of China (English)

    于鑫; 杜小沛; 张婷婷; 朱文彦

    2016-01-01

    Objective To evaluate the clinical effection of topical application of tranexamic acid used to treat with gingival bleeding in the cavity filling. Methods 115 patients with gingival bleeding after the cavity preparation were randomly divided into the experimental group and the control group. Tranexamic acid and 3% hydrogen peroxide were respectively used to stop the bleeding in two groups. Hemostasis effectiveness and hemostasis time were recorded. Results The hemostasis time in the experimental group was significantly shorter than that in the control group (P<0.05). There was no significant difference between two groups in the hemostatic efficiency. Conclusion Topical application of tranexamic acid is an effective treatment for gingival bleeding in the cavity filling. It can significantly shorten the hemostasis time compared with hydrogen peroxide. It is worthy of popularization and application.%目的:评价氨甲环酸局部压迫法治疗窝洞充填术中牙龈出血的临床效果。方法将窝洞预备后出现牙龈出血的115例患者随机分为试验组和对照组,分别采用氨甲环酸和3%过氧化氢进行局部压迫止血,分别记录止血有效性和止血时间。结果试验组止血时间较对照组显著缩短(P <0.05),两组止血有效率的差别无统计学意义(P >0.05)。结论氨甲环酸局部压迫法可有效治疗窝洞充填术中牙龈出血,较过氧化氢可明显缩短止血时间,值得推广应用。

  9. Clinical Trials

    Science.gov (United States)

    ... they are receiving. Other clinical trials involve a crossover design, where participants are randomly assigned to take a new treatment, a treatment already in use, and/or a placebo for a specified time ... If I am involved in a "crossover" clinical trial, can I go back to the ...

  10. Efficacy of Ruby Dot Matrix Laser Combined with Tranexamic Acid Tablets in the Treatment of Melasma%红宝石点阵激光联合氨甲环酸治疗黄褐斑临床观察

    Institute of Scientific and Technical Information of China (English)

    张璃; 林孝华; 唐东阳

    2012-01-01

    Objective To observe the clinical therapeutic efficacy of ruby dot matrix laser combined with tranexamic acid tablets in the treatment of melasma. Methods Laser treatment; choice dot matrix pattern, with energy density from 2. 5mJ/mm to 3. 5mJ/mm . Everyone accepted treatment twice one month. One course included 4 times of treatment. Everyone accepted only one course treatment. Tranexamic acid tablets treatment; Everyone was given tranexamic acid tablets 500mg per day, 2 months as 1 course. Everyone accepted 3 courses treatment. The severity and the area of melasma was assessed by two dermatologists using the melasma area severity index ( MASI). At regular in tervals the degree of improvement in pigmentation was reassessed with MASI scores. Effect appearance, recurrence, side-effects were also recorded. Results The 120 patients were followed for 6 ~ 12 months after treatment. 118 patients(98. 33% ) appeared the varying degree facial pigmentation loss. 5 cases(4. 17% ) was cured thoroughly, 74 cases(61.67% ) were cured better than before obviously. And in 39 cases treated for effective. The efficiency was 65. 84%. 37 patients (30. 83% ) showed clinical effect at the half-month treatment, 52 patients (43. 33%) showed clinical effect after one month treatment. Furthermore, only 8 patients(6. 67% ) had recurrences. There were no obvious side-effects of the treatment except a hypomenorrhea in 7 patients. Conclusion Ruby dot matrix laser combined with tranexamic acid tablets is a novel therapy, which is safe and effective in the treatment of melasma.%目的 对红宝石点阵激光联合氨甲环酸片治疗黄褐斑进行临床疗效观察.方法 激光治疗:采用点阵模式,能量密度2.5 ~ 3.5J/cm2,每隔2周治疗1次,2个月为1个疗程;同时口服氨甲环酸片500mg,1次/d,2个月为1个疗程,连续治疗3个疗程;对患者进行黄褐斑皮损面积和严重程度指数(MASI)评分,采用自身治疗前/后对照法进行疗效观察,记录起效

  11. Satisfaction and health-related quality of life in women with heavy menstrual bleeding; results from a non-interventional trial of the levonorgestrel-releasing intrauterine system or conventional medical therapy

    Directory of Open Access Journals (Sweden)

    Xu L

    2014-05-01

    Full Text Available Ling Xu,1 Byung Seok Lee,2 Shaheena Asif,3 Peter Kraemer,4 Pirjo Inki51Department of Gynecology and Obstetrics, Peking Union Medical College Hospital, Beijing, People’s Republic of China; 2Department of Obstetrics and Gynecology, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Korea; 3Department of Gynaecology and Obstetrics, Surgimed Hospital, Lahore, Pakistan; 4Global Medical Affairs Excellence and Operations, 5Global Medical Affairs Women's Healthcare, Bayer HealthCare, Berlin, GermanyPurpose: To evaluate the patient satisfaction and health related quality of life (HRQoL for levonorgestrel-releasing intrauterine system (LNG-IUS versus conventional medical treatments ([CMTs] combined oral contraceptives, oral progestins, and antifibrinolytics, alone or in combination in Asian women with heavy menstrual bleeding (HMB.Patients and methods: A total of 647 patients diagnosed with HMB were recruited to this non-interventional study from the eight participating countries in Asia. Patient satisfaction was recorded at the last visit (at 12 months or premature discontinuation. At each visit (at 3, 6, and 12 months, patients completed the menorrhagia multi-attribute scale (MMAS to assess HRQoL.Results: A total of 83.5% of patients on the LNG-IUS were “very satisfied” or at least “satisfied” with the therapeutic effect of HMB treatment, compared with 59.2% of patients with CMTs (P<0.05. The mean (± standard deviation MMAS score increased from 41.4±24.5 to 87.7±21.4 in the LNG-IUS arm, and from 44.1±24.9 to 73.1±25.3 in the CMTs arm. This increase was significantly higher in patients on the LNG-IUS, as compared with those on CMTs (P<0.05. The improvement in HRQoL in both treatment groups correlated with the body mass index of the patient, with larger improvement obtained in women with a higher body mass index.Conclusion: The majority of women using the LNG-IUS or CMTs for HMB were satisfied with their treatment

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits ... of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study ...

  13. Stroke Trials Registry

    Science.gov (United States)

    ... News About Neurology Image Library Search The Internet Stroke Center Trials Registry Clinical Trials Interventions Conditions Sponsors ... a clinical trial near you Welcome to the Stroke Trials Registry Our registry of clinical trials in ...

  14. Preparation and Ultrasound Imaging of Tranexamic Acid Microbubble-liposome Compound%氨甲环酸脂质体微泡复合物的制备及体外超声显影的初步研究

    Institute of Scientific and Technical Information of China (English)

    李婷; 严飞; 靳巧锋; 许瑞雪; 郑海荣; 李叶阔

    2013-01-01

    Purpose To prepare the tranexamic acid liposome with high encapsulation efficiency and stability, through interaction of avidin and biotin, and to prepare its microbubble-liposome compound whose properties are to be assessed. Materials and Methods Thin film hydration technology was used to prepare tranexamic acid liposome. Taking encapsulation efficiency as indication, the microbubble-liposome compound was optimized by the design of orthogonal experiment. The basic properties of the compound were tested and the acoustic characteristic was measured by ultrasound and gray-scale values. Results The optimum formula of tranexamic acid liposome were as follows:molar ratio of 1,2-dipalmitoyl-sn-glycero-3-phosphocholine, cholesterol and 1,2-distearoyl-sn-glycero-3-phosphoethanolamine-N-[biotinyl (polyethylene glycol) 2000] was 85∶10∶5;concentration of tranexamic acid was 5.0%;ultrasonic time was 15 min. The encapsulation efficiency was 62.62%. The size was approximately (104.00±1.84) nm. The Zeta potential was approximately (-50.50±0.56) mV. The liposome was good in stability. The size of the microbubble-liposome compound was approximately (4.56±0.28)μm. Under the microscope, they were round with transparent center, evenly distributed without aggregation. The acoustic characteristic of the compound in vitro showed typical characteristics of microbubble, which was compatible with the results under the microscope. As the concentrations of the compound increased, both ultrasound imaging effect and the gray-scale values enhanced. However, to avoid acoustic shadows, the imaging concentrations were supposed to be at least lower than 1.15×108/ml in vitro. Conclusion The preparation of the tranexamic acid microbubble-liposome compound can be optimized by taking encapsulation efficiency as reference, and it can be effectively traced by ultrasound according to its acoustic characteristics in vitro.%目的制备包封率高、稳定性好的氨甲环酸脂质体,并与微

  15. The Trial

    Science.gov (United States)

    Bryant, Jen

    2004-01-01

    Growing up in Flemington, New Jersey, put Jen Bryant in the heart of the lore behind the Lindbergh baby kidnapping. Family stories of the events of the day and extensive research led to "The Trial," a novel in verse. The first several parts of this novel are included here.

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... treatment, screening, diagnostic, prevention, and supportive care trials. Treatment Trials In treatment trials, researchers may gather information about experimental treatments, ...

  17. EFECTO DE DOS DOSIS BAJAS DE ÁCIDO TRANEXÁMICO EN EL SANGRADO POSTOPERATORIO DE CIRUGÍA CARDÍACA / Effect of two low doses of tranexamic acid in post-operative bleeding after cardiac surgery

    Directory of Open Access Journals (Sweden)

    Osvaldo González Alfonso

    2010-12-01

    Full Text Available Resumen Introducción y objetivos: En la cirugía cardiovascular puede ocurrir un sangrado excesivo, durante la intervención y después de esta. El objetivo de la investigación fue valorar los efectos de un protocolo de dosis bajas de ácido tranexámico en la prevención del sangrado postoperatorio cardiovascular. Método: Se realizó un estudio descriptivo, longitudinal, prospectivo, no aleatorizado, en el Cardiocentro de Santa Clara, con 51 pacientes operados con circulación extracorpórea, a los que se les administraron dos dosis de 1 gramo de ácido tranexámico; se evaluaron variables, como: tiempos de circulación extracorpórea, número de reintervenciones por fibrinolisis, cantidad de transfusiones administradas y cuantía de las pérdidas hemáticas en las primeras 24 horas de la intervención. Resultados: El sangrado postoperatorio promedió 1272,9 ± 1148,8 ml, el 52,9 % de los enfermos tuvieron pérdidas sanguíneas menores a 1000 ml en las primeras 24 horas de operados. El 58,8 % de los pacientes no requirió de transfusiones sanguíneas alogénicas, y solo se administraron a los enfermos transfundidos, un promedio de 1,7 ± 3,4 unidades de concentrado de glóbulos rojos. Solo dos pacientes requirieron ser reintervenidos por fibrinólisis exagerada. Conclusiones: Las dosis bajas de ácido tranexámico empleadas en el estudio demostraron ser útiles para reducir el sangramiento postoperatorio en la cirugía cardíaca, a la vez que mantienen bajo el número de transfusiones alogénicas. / Abstract Introduction and objectives: In cardiovascular surgery an excessive bleeding can occur, both during the surgical procedure and after it. The objective of this investigation was to assess the effects of a low dose protocol of tranexamic acid in the prevention of bleeding following cardiovascular surgery. Method: A descriptive, longitudinal, prospective and non-randomized study with 51 patients who underwent surgery with extracorporeal

  18. Q开关1064 nm激光联合氨甲环酸治疗黄褐斑临床观察%Combined Q-Switched Nd: YAG Laser and oral tranexamic acid for the treatment of melasma

    Institute of Scientific and Technical Information of China (English)

    邓永辉; 苑凯华; 李勤; 蔡金辉

    2013-01-01

    目的 探讨Q开关1064 nm激光联合氨甲环酸治疗黄褐斑的临床疗效和安全性.方法 100例黄褐斑患者随机分为两组,每组50例.A组接受Q开关1064 nm激光治疗,同时口服氨甲环酸;B组单纯接受Q开关1064 nm激光治疗.经过3个疗程治疗后观察疗效及不良反应.结果 A组基本治愈率46%,有效率74%;B组基本治愈率18%,有效率30.2%,两组疗效差异有统计学意义(P<0.05).口服氨甲环酸8个月未见严重不良反应.结论 口服氨甲环酸可提高Q开关1064 nm激光治疗黄褐斑的临床疗效,且不良反应小.%Objective To explore the clinical effect and safety of treating melasma with the combination of Q-Switched Nd:YAG Laser and oral tranexamic acid. Methods One hundred patients were randomly divided into group A and B. Group A was treated by Q-Switched Nd:YAG Laser combinated with oral tranexamic acid. Group B was only treated by Q-Switched Nd:YAG Laser. The clinical effect and side effects were observed after three courses of treatment. Results In group A, the basic cure rates was 46%, total effective rate was 74%. In group B, the basic cure rates was 18%, total effective rate was 30.2%. The results had significant difference between the two groups (P<0.05). Conclusion Combination therapy can promote the efficacy of melasma and without severe side-effects.

  19. Q开关激光辅助氨甲环酸治疗黄褐斑疗效观察%Clinical efficacy of using Q-Switched Nd:YAG Laser combined with tranexamic acid for the treatment of melasma

    Institute of Scientific and Technical Information of China (English)

    陈晓莉; 蒋艳; 皮超; 王鸿健; 高鹃

    2015-01-01

    目的:观察Q开关1064nm激光辅助氨甲环酸治疗黄褐斑的疗效与不良反应。方法:入组女性黄褐斑患者共280例,随机分两组,每组140例。治疗组:采用Q开关1064nm激光辅助口服氨甲环酸治疗;对照组:单独使用Q开关1064nm激光治疗。治疗6个周期后对比分析两组患者疗效与不良反应情况。结果:治疗组基本治愈率46.43%,有效率75.00%;对照组基本治愈率17.86%,有效率32.14%,两组间差异有统计学意义(P<0.05)。治疗组无严重不良反应发生。结论:Q开关1064nm激光辅助口服氨甲环酸可以提高黄褐斑的疗效。%Objective To explore the clinical efficacy of using Q-Switched Nd:YAG Laser combined with tranexamic acid for the treatment of melasma. Methods Two hundred and eighty patients were randomized into treatment group and control group. The treatment group was treated by Q-Switched Nd:YAG Laser combinated with oral tranexamic acid. The control group was only treated by Q-Switched Nd:YAG Laser. The clinical effect and side effects were observed after six courses of treatment. Results In the treatment group, the basic cure rates was 46.43%, total effective rate was 75.00%. In the control group, the basic cure rates was 17.86%, total effective rate was 32.14%. The results had significant difference between the two groups (P<0.05). Conclusion Combination therapy can promote the efficacy of melasma and without severe side effects.

  20. What Are Clinical Trials?

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials What Are Clinical Trials? Past Issues / Fall 2010 Table of Contents Clinical ... conducted all the time. The Different Phases of Clinical Trials Clinical trials related to drugs are classified into ...

  1. Participating in Clinical Trials

    Science.gov (United States)

    ... this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical ... to treat or cure a disease. Phases of Clinical Trials Clinical trials of drugs are usually described based ...

  2. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Usually, trial participants must show signs of the disease or condition before they can join this type of trial. Prevention Trials Click for more information In prevention trials, ...

  3. The clinical observation of optimal pulse technology therapy combined with intradermal injection of tranexamic acid on melasma%优化脉冲技术联合皮内注射氨甲环酸治疗黄褐斑临床观察

    Institute of Scientific and Technical Information of China (English)

    吴志波; 芦桂青; 孙慧; 李冬花; 李丙燕

    2016-01-01

    Objective To explore the clinical efifcacy and safety of optimal pulse technology (OPT) combined with intradermal injection of tranexamic acid on melasma. Methods Total of 74 patients with melasma were randomly divided into two groups,the OPT group and the combining group. OPT group (39 cases) only accepted the OPT treatment, the combining group (35 cases) accepted treatment with OPT and intradermal injection of ammonia tranexamic acid. After one course of treatment, clinical efifcacy and adverse reaction of both groups were observed. Results In the OPT group, the cure rate was 20.5%, the efifcient rate was 64.1%. In the combining group, the cure rate was 31.4%, the efifcient rate was 85.7%. There were signiifcantly difference between OPT group and combining group (P<0.05). Local injection of tranexamic acid had no obvious adverse reaction. Conclusion OPT with local intradermal injection of tranexamic acid are effective on the treatment of melasma without side effects.%目的:探讨优化脉冲技术(Optimal Pluse Technology, OPT)联合皮内注射氨甲环酸治疗黄褐斑的临床疗效及安全性。方法:将74例黄褐斑患者随机分为两组,分别为OPT组和联合组。OPT组:39例,仅接受OPT治疗;联合组:35例,接受OPT治疗的同时皮内注射氨甲环酸注射液,经过1个疗程治疗后观察疗效及不良反应。结果:OPT组治愈率20.5%,有效率64.1%;联合组治愈率31.4%,有效率85.7%,两组疗效比较具有统计学差异(P<0.05),局部注射氨甲环酸未见明显不良反应。结论:OPT联合局部皮内注射氨甲环酸注射液能有效治疗黄褐斑,且安全性高。

  4. Types of Treatment: Clinical Trials

    Science.gov (United States)

    ... Disease Information Treatment Types of Treatment Clinical Trials Clinical Trials Clinical Trials SHARE: Print Glossary Taking part in a clinical ... for cancer are based on previous clinical trials. Clinical Trial Service: LLS provides personalized clinical trial navigation when ...

  5. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial is to find out if an experimental drug, therapy, medical device, lifestyle change, or test will ... disease. Phases of Clinical Trials Clinical trials of drugs are usually described based on their phase. The ...

  6. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... trial. Prevention Trials Click for more information In prevention trials, researchers study ways to reduce the risk of getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  7. Clinical Trials in Vision Research

    Science.gov (United States)

    ... Eye Health Information > Clinical Trials in Vision Research Clinical Trials in Vision Research Clinical studies depend on people ... vision research in the United States. Basics of Clinical Trials What is a clinical trial? Clinical trials are ...

  8. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Studies NHLBI Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical ... protect patients and help produce reliable study results. Clinical Trial Protocol Each clinical trial has a master plan ...

  9. Informed Consent (Clinical Trials)

    Science.gov (United States)

    ... Research Cancer Treatment Types of Treatment Side Effects Clinical Trials Information A to Z List of Cancer Drugs ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer ...

  10. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  11. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  12. Gadolinium Complex of 1,4,7,10-Tetraazacyclododecane-N,N',N'',N'''-1,4,7-trisacetic Acid (DO3A) Conjugate of Tranexamates: A Quest for a Liver-specific Magnetic Resonance Imaging Contrast Agent

    Energy Technology Data Exchange (ETDEWEB)

    Nam, Kisoo; Jeong, Hyunjeong; Kim, Heekyung; Choi, Garam; Chang, Yongmin; Kim, Taejeong [Kyungpook National Univ., Daegu (Korea, Republic of); Suh, Kyungjin [Dongguk Univ., Kyungju (Korea, Republic of)

    2014-01-15

    The work is directed toward the synthesis of a series of DO3A conjugates of tranexamates (1c-e) and their Gd complexes (2c-e) for use as a liver-specific MRI CA. All these complexes show thermodynamic and kinetic stabilities comparable to those of structurally related clinical agents such as Dotarem. Their R{sub 1} relaxivities also compare well with those of commercial agent, ranging 3.68-4.84 mM{sup -1}s{sup -1}. In vivo MR images of mice with 2a-e reveal that only 2a exhibits liver-specificity. Although 2b and 2c show strong enhancement in liver, yet no bile-excretion is observed to be termed as a liver-specific agent. The rest behaves much like ordinary ECF CAs like Dotarem. The new series possess no toxicity to be employed in vivo.

  13. Understanding noninferiority trials

    Directory of Open Access Journals (Sweden)

    Seokyung Hahn

    2012-11-01

    Full Text Available Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

  14. Diagnosis and Treatment of Hyperfibrinolysis in Trauma (A European Perspective).

    Science.gov (United States)

    Gall, Lewis S; Brohi, Karim; Davenport, Ross A

    2017-03-01

    Fibrinolysis activation occurs almost universally after severe trauma. Systemic hyperfibrinolysis is a key component of acute traumatic coagulopathy and associated with poor clinical outcomes, although controversy exists over optimal treatment strategies. The mechanistic drivers and dynamics of fibrinolytic activation in response to injury and trauma resuscitation are currently unclear. Furthermore, therapeutic triggers are compounded by the lack of a sensitive and rapid diagnostic tool, with discrepancy between hyperfibrinolysis diagnosed by viscoelastic hemostatic assays versus biomarkers for fibrinolysis. Rotational thromboelastometry and thromboelastography appear capable of detecting the severest forms of hyperfibrinolysis but are relatively insensitive to moderate, yet clinically significant fibrinolytic activation. Rapid evaluation of the current status of the fibrinolytic system remains a challenge and therefore the decision whether to administer an antifibrinolytic agent should be based on available evidence from clinical trials. In line with current European guidelines, we recommend that all bleeding trauma patients, and in particular, severely injured patients with evidence of hemorrhagic shock, should receive early empiric tranexamic acid. This review explains our current knowledge of the pathophysiological pathways which induce hyperfibrinolysis in trauma hemorrhage, evaluates the available diagnostic modalities, and describes current treatment strategies.

  15. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... disease or prevent a disease from returning. Supportive Care Trials In supportive care trials, researchers look for ways to make life ... groups, and various types of social interventions. Supportive care interventions are not intended to treat or cure ...

  17. Study on the Protective Effect of Tranexamic Acid Evaluated by Thromboelastography in Cardiopulmonary Bypass%血栓弹力图评价氨甲环酸在体外循环中的血液保护效果的研究

    Institute of Scientific and Technical Information of China (English)

    丰巨龙; 吴海军; 姜文斌; 李征; 张杰; 程显峰

    2015-01-01

    [ ABSTRACT] Objective To evaluate the protective effect of tranexamic acid in valve replacement patients through thromboelastog-raphy on coagulation function of statistical evaluation,and further to determine the optimal dosage of tranexamic acid in cardiopulmonary by-pass.Methods One hundred cases of valve replacement patients were randomly divided into four groups:A,B,C,D groups.Group B,group C and group D were respectively treated with ammonia tranexamic acid powder( load Mo plug) and the dose is 20mg/kg,40mg/kg,60mg/kg (diluted to 50ml to join in the perfusion solution),each half of the total amount was given in priming solution during rewarming of cardiopul-monary Bypass.Group A was given 50ml normal saline at the corresponding time points,recording the activated clotting time( ACT) before, during and after CPB;before transfer(T1),heparin and after(T2),heparin and after 3h(T3),TEG examination were performed in the inter-nal jugular vein.Results There was no significant difference about the results of TEG among the four groups before CPB(T1).After neutral-ization(T2),there was no significant difference among the 4 groups.While in heparin and 3h(T3),compared to group A,the values of group B,C,D were significantly different,R values and K values were significantly lower than those in group A,MA and a values were significantly increased compared with A.But there were no significant difference among B,C,D three groups;The results of coagulation function tests be-fore and after CPB were compared and analysed,and the results showed that the two time points after CPB were significantly different.Com-pared to the preoperative,the value R and K were significantly prolonged,and the value MA and a were significantly decreased.Conclusion The application of tranexamic acid contribute to the protection of the coagulation system during cardiopulmonary bypas in heart valve replace-ment surgery,either to platelet or to coagulation factor fiber protein.20mg/kg,40 mg/kg,60mg

  18. 磷酸肌酸钠复合氨甲环酸对非体外循环冠状动脉旁路移植术患者心肌和血液保护作用的研究%The myocardial and blood protectivie effects of creatine phosphate sodium combined with tranexamic acid in off-pump coronary artery bypass grafting

    Institute of Scientific and Technical Information of China (English)

    李长营; 郭爱华; 张宗旺; 张学俊; 张雷; 敖虎山

    2011-01-01

    Objective To investigate whether the supplement of creatine phosphate sodium and tranexamic acid to cardioplegic solutions can improve myocardial protection and blood conservation in off-pump coronary artery bypass graft(OPCABG).Methods 280 patients undergoing OPCABG were randomly assigned to experimental group (CP with TA group, n=70 ) , creatine phosphate sodium group (CP group, n=70), tranexamic acid group (TA group, n=70) and control group (n=70). Before BACG,creatine phosphate sodium ( 100 mg/kg) combined with tranexamic acid (30 mg/kg), creatine phosphate sodium ( 100 mg/kg),tranexamic acid (30 mg/kg), and equal volume of normal saline were given intravenously in each group respectively. Venous blood samples were taken preoperatively, and at 0, 6, 12, 24, 48, 72 h, 7 d postoperatively to analyze creatine kinase isoenzyme (CK-MB), troponin (cTnI) ; Meanwhile, the amount of cumulative chest fluid drainage and inotropic agent and blood transfused were also recorded. Results The plasma concentrations of CK-MB in experimental group at 6, 12, 24, 48, 72 h postoperatively (15±6), (14±5), (16±10), (15±6) and (13±6) U/ml and the plasma concentrations of cTnI(235±1.53), (2.72±1.46), (2.64±1.32),(1.16±0.76) and (0.48±0.24) mg/L were significantly lower than those in group CP, group TA and control group (P<0.05). The amount of postoperative cumulative chest fluid at 6, 12, 24, 48, 72 h were (246±56), (420±82), (680±114), (725±126) and (730±130) ml drainage and blood transfuison in experimental group (5/70) were also significantly lower than those in other groups (P<0.05). Conclusion For patients undergoing OPCABG, creatine phosphate sodium combined with tranexamic acid plays an important role in myocardial protection and blood conservation without increasing the surgical mortality and the incidence of postoperative complications.%目的 研究在非体外循环下行冠状动脉旁路移植术(off-pump coronary artery bypass grafting,OPCABG)中应用

  19. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Trials Insurance Coverage and Clinical Trials How to Work With Your Health Insurance Plan Federal Government Programs Patient Safety Informed Consent Children's Assent Scientific Review Ending Trials Early Deciding to Take Part ...

  20. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  1. 1029: Tranexamic Acid for Pediatric Trauma

    Science.gov (United States)

    2014-12-01

    Scale, admission temperature, hematocrit, base deficit, INR, and platelet count . Mechanism of injury differed significantly between groups. TXA...Angeles, USA Learning Objectives: Sepsis remains a major cause of morbidity and mortality in children worldwide. The clinical findings and subsequent...critically ill adult patients have produced mixed results. The association between CRP trend and mortality has not been described for children with

  2. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P;

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity...... with a larger number of patients and a longer follow-up will contribute more to the overview's results....

  3. 髋关节置换后氨甲环酸关节腔注射及间断夹管:出血量的变化%Tranexamic acid injection through articular cavity and discontinuous clip pipe after total hip arthroplasty:changes in bleeding amount

    Institute of Scientific and Technical Information of China (English)

    凡福成; 桂斌捷

    2014-01-01

    BACKGROUND:With the increased number of patients with total hip arthroplasty, blood source became less gradual y. Simultaneously, the risk of a variety of serious diseases infected by blood transfusion troubled the patients. Thus, it is very important to find a method that can reduce blood transfusion and did not increase risk. There are reports addressing the application of tranexamic acid to reduce bleeding during total knee, total hip arthroplasty and spinal surgery. OBJECTIVE:To explore the effects of injection with tranexamic acid through articular cavity and discontinuous clip pipe on blood loss, functional recovery and complication after total hip arthroplasty. METHODA total of 99 patients, who received total hip arthroplasty because of femoral fracture or coxarthropathy from January 2011 to February 2014, were selected in this study. They were divided into tranexamic acid group (n=55) and control group (n=44). After skin suture, patients in the tranexamic acid group were injected with 2.0 g tranexamic acid dissolved in 20 mL physiological saline through articular cavity. After replacement, the drainage was opened after 2 hours of interval. From then on, the drainage was opened for 10 minutes every 4 hours. Patients in the control group received discontinuous clip pipe. Negative pressure drainage tube was pul ed out at 48 hours after replacement. Blood loss, the number of blood transfusion, blood transfusion volume, 24-hour postoperative hemoglobin and hematocrit, preoperative, 3-hour postoperative fibrinogen, prothrombin time and activated partial thromboplastin time, 6-month postoperative hip Harris score and lower extremity deep vein thrombosis or pulmonary embolism were compared between the two groups. RESULTS AND CONCLUSION:Significant differences in blood loss, the number of blood transfusion, blood transfusion volume, 24-hour postoperative hemoglobin and hematocrit were visible after replacement in patients of both groups (P0.05). No significant

  4. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... to obtain preliminary data on whether the drug works in people who have a certain disease or condition. These trials also continue to study safety, including short-term side effects. This phase ...

  5. Anchor Trial Launch

    Science.gov (United States)

    NCI has launched a multicenter phase III clinical trial called the ANCHOR Study -- Anal Cancer HSIL (High-grade Squamous Intraepithelial Lesion) Outcomes Research Study -- to determine if treatment of HSIL in HIV-infected individuals can prevent anal canc

  6. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... out if an experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or ... specific medical problem. These trials find out if lifestyle changes, such as exercising more, getting more sleep, ...

  7. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... a disease. A clinical trial may compare experimental products or tests to those already available or may ... Institutes of Health | U.S. Department of Health & Human Services Customer Support | Accessibility | Copyright | Privacy | Viewers and Players

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... new tests that could identify a disease in its early stages. Usually, trial participants must show signs ... often healthy people (20 to 80), to judge its safety and side effects, and to find the ...

  9. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... experimental drug, therapy, medical device, lifestyle change, or test will help treat, find, or prevent a disease. A clinical trial may compare experimental products or tests to those already available or may compare existing ...

  10. Polyp Prevention Trial

    Science.gov (United States)

    The primary objective of the Polyp Prevention Trial (PPT) is to determine whether a low fat, high fiber, high vegetable and fruit eating plan will decrease the recurrence of adenomatous polyps of the large bowel.

  11. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  12. Falsificationism and clinical trials.

    Science.gov (United States)

    Senn, S J

    1991-11-01

    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  13. Meta-analysis to the effect of tranexamic acid on blood loss in total knee arthroplasty%氨甲环酸对全膝关节置换术失血量影响的系统评价

    Institute of Scientific and Technical Information of China (English)

    傅德杰; 陈凯宁; 杨柳

    2012-01-01

    [Objective] To assess the effect and safety of tranexamic acid (TA) used in total knee arthroplasty (TKA) by making a systematic review and meta - analysis. [Methods] Literatures were retrieved from Coehrane Library (CENTRAL, 2011 Issue 4), Ovid (1948 to December 2011), PubMed (1966 to December 2011), EMBASE (1966 to December 2011) and CNKI (1994 to December 2011) . All the related literatures were checked by two independent reviewers and only the high quality randomized controlled trails (RCTs) were enrolled. The relevant data were analyzed using RevMan 5.0 to compare the difference of blood loss, transfusion and complications between TA group and placebo group. [ Results] Only IS high quality RCTs met the inclusion criteria. The use of TA in TKA significantly reduced total blood loss by a mean of 513. 03 ml [95% confidence interval (CI) ( -629, -344), P<0.01], intra - operative blood loss by a mean of 94.03 ml [95%CI ( -297.97, 91.92), P = 0.32], post -operative blood loss by a mean of 297.00 ml [95% CI (-772.50, 178.05), P = 0.22] . TA significantly reduced the rate of transfusion [risk difference 0.29, 95%CI ( -0.40, -0.17), P<0.01] and transfusion unit [mean difference 0.99, 95%CI(-1.48, -0.49), P<0.01] . The risks between TA group and placebo group in developing deep - vein thrombosis (DVT) and pulmonary embolism (PE) were not statistically significant. [ Conclusion] The use of TA could significantly reduce total blood loss, the rate of transfusion and transfusion unit in patients undergoing TKA. TA does not lead to an increasing risk of DVT and PE.%[目的] 评价氨甲环酸对全膝关节置换术后失血量等指标的影响及其安全性.[方法] 利用互联网检索数据库The Cochrane Library(2011年第4期)、Ovid(1948年~2011年12月)、PubMed(1966年~2011年12月)、EMBASE(1966年~2011年12月)、中国期刊全文数据库(CNKI,1994年~2011年12月),检出氨甲环酸在全膝关节置换术中应用的相关文献,筛选出符合纳

  14. Ethics and clinical trials.

    Science.gov (United States)

    Chassany, O; Duracinský, M

    1999-01-01

    The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.

  15. The FOCUS trial

    DEFF Research Database (Denmark)

    Glenthøj, Louise B; Fagerlund, Birgitte; Randers, Lasse

    2015-01-01

    trial enrolling 126 patients meeting the standardised criteria of being at UHR for psychosis. Patients are recruited from psychiatric in- and outpatient facilities in the Copenhagen catchment area. Patients are randomised to one of the two treatment arms: cognitive remediation plus standard treatment...... functioning, psychosis-like symptoms, negative symptomatology, and depressive symptomatology as measured with the Personal and Social Performance Scale, Brief Psychiatric Rating Scale-Expanded Version, Scale for the Assessment of Negative Symptoms, and the Montgomery-Åsberg Depression Rating Scale. DISCUSSION......: This is the first trial to evaluate the effects of neurocognitive and social cognitive remediation in UHR patients. The FOCUS trial results will provide evidence on the effect of targeted and comprehensive cognitive rehabilitation on cognition, daily living, and symptomatology as well as long-term outcome...

  16. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...... of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute...... both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials...

  17. 全髋置换局部应用氨甲环酸后输血及成本效益分析%Postoperative Blood Loss,Transfusion and Cost Benefit Analysis of Topical Tranexamic Acid in To﹣tal Hip Arthroplasty

    Institute of Scientific and Technical Information of China (English)

    谢美兆; 练伟东; 张浩; 张智勉; 郭达

    2016-01-01

    Objective To investigate the effects of topical Tranexamic Acid technique on blood loss,transfusion and cost benefit in total hip arthroplasty(THA). Methods 80 patients underwent THA from Mar 2013 to Mar 2014 were enrolled and randomly divided into Tranexamic acid group(T group,n = 40)or Control group(C group,n = 40). In T group 2. 0 g tranex-amic acid(20 mL)were prepared. 10 mL were injected peri ﹣ articularly after prosthesis was on position. 10 mL were injected intro ﹣ articularly after iliotibial band was sutured. In C group,20 mL saline were prepared,the administration was the same with T group. visible blood loss,hidden blood loss,blood transfusion per patient,24-hour postoperative red blood cell count,he-moglobin,hematocrit,3-hour postoperative prothrombin time and activated partial thromboplastin time were recorded and com-pared. Total transfusion cost,total hospitalization cost,cost per-patient,cost-benefit ratio were recorded and counted. Results Significant differences were found in visible blood loss,hidden blood loss,blood transfusion per-patient,24-hour postoperative red blood cell count,hemoglobin,hematocrit(P ﹤ 0. 05),suggesting better blood loss control in T group than C group. No sig-nificant difference in 3-hour postoperative prothrombin time and activated partial thromboplastin time(P ﹥ 0. 05). The cost of transfusion,hospitalization,per patient were lower in T group than C group. Cost-benefit ratio was 29. 164. Conclusion Topi-cal Tranexamic Acid technique in total hip arthroplasty can obviously decrease postoperative blood loss and per patient blood transfusion,and cut down the cost of hospitalization,showing good advantage in cost-benefit control.%目的:研究全髋置换术后局部应用氨甲环酸的输血及成本效益分析。方法研究选取2013年5月至2014年5月行全髋关节置换的患者80例,随机分为氨甲环酸组(T 组)40例,对照组(C 组)40例。T 组取2.0 g(20 mL)氨甲环酸,于假

  18. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.;

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...... and index knee, describing interventions, patient-reported and physical performance measures, structural outcome measures, biochemical biomarkers, and reporting recommendations. In summary, the working group identified 25 recommendations that represent the current best practices regarding clinical trials...... that target symptom or structure modification among individuals with knee OA. These updated recommendations incorporate novel technologies (e.g., magnetic resonance imaging (MRI)) and strategies to address the heterogeneity of knee OA....

  19. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.;

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...

  20. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... will not know if you are taking the medicine or the placebo until the clinical trial is over. How do ... can already get by prescription ) or sugar pills ( placebos ) with the new medicine may last longer than Phases I and II ...

  1. Participating in Clinical Trials

    Medline Plus

    Full Text Available skip navigation Help Search home health topics A-Z Videos A-Z about us Customer Support NIH SeniorHealth Built with You in Mind Resize Text: A A A Change Contrast print sign up Share Home > Health topics A-Z > Participating in Clinical Trials: About ...

  2. Clinical Trial Basics

    Science.gov (United States)

    ... How Am I Protected? Mark Bowden / iStock Ethical guidelines The goal of clinical research is to develop knowledge that improves human ... data and decide whether the results have medical importance. Results from clinical trials are often published in peer-reviewed scientific ...

  3. Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term randomised pragmatic trial in primary care

    Science.gov (United States)

    Kai, Joe; Middleton, Lee; Daniels, Jane; Pattison, Helen; Tryposkiadis, Konstantinos; Gupta, Janesh

    2016-01-01

    Background Heavy menstrual bleeding (HMB) is a common, chronic problem affecting women and health services. However, long-term evidence on treatment in primary care is lacking. Aim To assess the effectiveness of commencing the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice. Design and setting A pragmatic, multicentre, parallel, open-label, long term, randomised controlled trial in 63 primary care practices across the English Midlands. Method In total, 571 women aged 25–50 years, with HMB were randomised to LNG-IUS or usual medical treatment (tranexamic/mefenamic acid, combined oestrogen–progestogen, or progesterone alone). The primary outcome was the patient reported Menorrhagia Multi-Attribute Scale (MMAS, measuring effect of HMB on practical difficulties, social life, psychological and physical health, and work and family life; scores from 0 to 100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality of life, sexual activity, and safety. Results At 5 years post-randomisation, 424 (74%) women provided data. While the difference between LNG-IUS and usual treatment groups was not significant (3.9 points; 95% confidence interval = −0.6 to 8.3; P = 0.09), MMAS scores improved significantly in both groups from baseline (mean increase, 44.9 and 43.4 points, respectively; P<0.001 for both comparisons). Rates of surgical intervention were low in both groups (surgery-free survival was 80% and 77%; hazard ratio 0.90; 95% CI = 0.62 to 1.31; P = 0.6). There was no difference in generic quality of life, sexual activity scores, or serious adverse events. Conclusion Large improvements in symptom relief across both groups show treatment for HMB can be successfully initiated with long-term benefit and with only modest need for surgery. PMID:27884916

  4. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... NICHD Publications Data Sharing and Other Resources Research Clinical Trials & Clinical Research Skip sharing on social media links ... health care providers, and researchers. Find NICHD-Supported Clinical Trials Use this link to find a list of ...

  5. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Trials Information A to Z List of Cancer Drugs Complementary & Alternative Medicine (CAM) Questions to Ask about ... Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & Cancer Adjusting to ...

  6. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Unusual Cancers of Childhood Treatment Childhood Cancer Genomics Study Findings Metastatic Cancer Metastatic Cancer Research Common Cancer ... Trials Insurance Coverage and Clinical Trials How to Work With Your Health Insurance Plan Federal Government Programs ...

  7. HIV/AIDS Clinical Trials

    Science.gov (United States)

    ... Home Apps APIs Widgets Order Publications Skip Nav HIV/AIDS Clinical Trials Home > Clinical Trials Español small ... Renal (Kidney) Complications/Damage Skin Diseases FDA-Approved HIV Drugs Abacavir Atazanavir Atripla Cobicistat Combivir Complera Darunavir ...

  8. Determinants of Bleeding Risk in Patients on Antithrombotic and Antifibrinolytic Drugs

    NARCIS (Netherlands)

    Meijer, Karina; Schulman, Sam

    2008-01-01

    The risk of bleeding associated with antithrombotic and fibrinolytic therapy depends on factors that are specific for the drugs and the patients. In this narrative review, we describe the most important risk factors for bleeding for each class of drugs. Pertinent examples are recent initiation of th

  9. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  10. The Trial of Katherine Harrison.

    Science.gov (United States)

    Woodward, Walter W.

    2003-01-01

    Presents a lesson plan in which the teacher and students participate in a mock trial of Katherine Harrison, who was accused of witchcraft in the seventeenth century. Provides background information about the trial, as well as primary sources of the testimonies given by witnesses during the trial. (CMK)

  11. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies......To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each...... challenge raised in the paper, we propose potential solutions. Enrollment poses challenges in maintaining investigator equipoise, managing conflict of interest and anticipating that patient preferences for specific treatments may reduce enrollment. Intervention design and implementation pose challenges...

  12. The COLOFOL trial

    DEFF Research Database (Denmark)

    Hansdotter Andersson, Pernilla; Wille-Jørgensen, Peer; Horváth-Puhó, Erzsébet

    2016-01-01

    trial, comparing demographic characteristics between randomized patients and eligible patients not included in the study. MATERIALS AND METHODS: COLOFOL was designed as a pragmatic trial with wide inclusion criteria and few exclusion criteria, in order to obtain a sample reflecting the general patient...... population. To be eligible, patients had to be 75 years or younger and curatively resected for stage II or III colorectal cancer. Exclusion criteria were hereditary colorectal cancer, no signed consent, other malignancy, and life expectancy less than 2 years due to concomitant disease. In four of the 24...... in tumor location and stage distribution, with 5.6% more patients in the randomized group having colon cancer and 6.7% more patients having stage II disease. CONCLUSION: Patients in the two study arms were not only demographically similar, but also similar to nonincluded eligible patients, apart from stage...

  13. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2007-01-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: 4'-Thio-ara-C, 5-methyltetrahydrofolate; ABT-089, AD-237, AF-37702, alvocidib hydrochloride, apricitabine, armodafinil, atrasentan, AVE-5883, avian influenza vaccine, azimilide hydrochloride; Banoxantrone, BIBF-1120; CD34+ cells, certolizumab pegol, CHIR-258, cilansetron, CoFactor, CX-3543, cystemustine; D-003, dexloxiglumide, DMXB-anabaseine; Ecogramostim, elcometrine, elcometrine/ethinylestradiol, etravirine; Fenretinide, fingolimod hydrochloride, fospropofol disodium; Gaboxadol, gestodene, glutamine; Human insulin, hyaluronic acid; Incyclinide, indacaterol, ispronicline, istradefylline; Labradimil, lamifiban, lapatinib, L-arginine hydrochloride, liposomal cisplatin, liposome encapsulated paclitaxel, LY-517717; Manidipine hydrochloride/delapril hydrochloride, maraviroc, MBP(82-98), MD-0727, MDX-214, melanotan I, MMR vaccine; Nacystelyn, nalfurafine hydrochloride, nibentan, nilotinib, NK-105; OBI-1, oblimersen sodium, olmesartan medoxomil, olmesartan medoxomil/hydrochlorothiazide, oregovomab; Pexelizumab, PG-116800, PG-CPT, PHA-794428, prasugrel; RC-3095, rDNA insulin, RFB4(dsFv)-PE38, rhEndostatin, rhenium Re-186 etidronate, rhGM-CSF, roflumilast, romidepsin; Sarcosine, SGLU1, SGN-40, succinobucol; TAU, teduglutide, telatinib, tesofensine, tipifarnib, tirapazamine, TKA-731, tolvaptan, trabectedin; Vaccimel, vatalanib succinate, velafermin, vildagliptin, vinflunine; XP-19986; YM-155.

  14. A guide to clinical trials for cancer

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/patientinstructions/000823.htm A guide to clinical trials for cancer To use ... trial and where to find one. What is a Clinical Trial for Cancer? Clinical trials for cancer ...

  15. SMi's Conducting Clinical Trials in Europe.

    Science.gov (United States)

    Jago, Charlotte

    2009-12-01

    The Conducting Clinical Trials in Europe meeting, held in London, included topics covering new developments in the field of clinical trials and recommendations on how to best conduct a trial. This conference report highlights selected presentations on the state of affairs of trials in Europe, conducting trials in emerging markets, strategies for improving trials, trial design options, peri-approval and pediatric trials, and the role of key players, such as physicians. Company perspectives from Pfizer Inc and Nycomed are also included.

  16. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  17. The ONTARGET trial programme

    DEFF Research Database (Denmark)

    Unger, Thomas; Kintscher, Ulrich; Kappert, Kai;

    2009-01-01

    The ONTARGET trial programme tested the effects of the angiotensin AT1 receptor blocker (ARB), telmisartan, alone or in combination with the angiotensin converting enzyme (ACE) inhibitor, ramipril, in more than 25.000 patients at high cardiovascular risk including diabetes on a combined endpoint ....... Telmisartan thus proved to be the first and so far the only representative of the ARB class that can be used as an alternative to the "gold standard" ACE-inhibitor, ramipril, in patients at high cardiovascular risk with or without hypertension. © 2009 Bentham Science Publishers Ltd....

  18. The CHANGE trial

    DEFF Research Database (Denmark)

    Speyer, Helene; Christian Brix Nørgaard, Hans; Birk, Merete;

    2016-01-01

    Life expectancy in patients with schizophrenia is reduced by 20 years for men and 15 years for women compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being dominant. CHANGE was a randomized, parallel-group, superiority...... cardiorespiratory fitness, physical activity, weight, diet and smoking. In conclusion, the CHANGE trial did not support superiority of individual lifestyle coaching or care coordination compared to treatment as usual in reducing cardiovascular risk in patients with schizophrenia spectrum disorders and abdominal...

  19. Practical trials in medical education

    DEFF Research Database (Denmark)

    Tolsgaard, Martin G; Kulasegaram, Kulamakan M; Ringsted, Charlotte

    2017-01-01

    controlled settings generalise to the real-life education context. One way of bridging this gap is applying the concept of practical trials in medical education. In this paper we elaborate on characteristics of practical trials and based on examples from medical education we discuss the challenges...... administration, quality of care, patient outcomes and cost. CONCLUSIONS: Practical trials in medical education may contribute to bridge the gap between education theory and practice and aid decision makers in making evidence-based choices and priorities. Conducting practical trials is not without challenges...

  20. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Phases of Clinical Trials Cancer Treatment Types of Cancer Treatment Surgery Radiation Therapy Chemotherapy Immunotherapy Targeted Therapy Hormone Therapy Stem Cell Transplant Precision ...

  1. Gateways to clinical trials.

    Science.gov (United States)

    Bayes, M; Rabasseda, X; Prous, J R

    2005-01-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (-)-Epigallocatechin gallate; ACP-103, Ad.Egr.TNF.11 D, adalimumab, AF-IL 12, AIDSVAX gp120 B/B, alefacept, alemtuzumab, a-Galactosylceramide, ALVAC vCP 1452, alvimopan hydrate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anidulafungin, antarelix, aprepitant, aripiprazole, arsenic sulfide, asoprisnil, atazanavir sulfate, atomoxetine hydrochloride; Bevacizumab, bimatoprost, BMS-184476, bortezomib, bosentan, botulinum toxin type B, BrachySil, brivudine; Caffeine, calcipotriol/betamethasone dipropionate, cannabidiol, capsaicin for injection, caspofungin acetate, CC-4047, cetuximab, CGP-36742, clofazimine, CpG-7909, Cypher; Darbepoetin alfa, dextromethorphan/quinidine sulfate, dimethylfumarate, dronabinol/cannabidiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecogramostim, efalizumab, eletriptan, emtricitabine, enfuvirtide, eplerenone, esomeprazole magnesium, estradiol acetate, eszopiclone, etoricoxib, exenatide, ezetimibe, ezetimibe/simvastatin; Fampridine, fondaparinux sodium, fosamprenavir calcium; Gefitinib, GPI-0100; hA 20, HTU-PA, human insulin, HuOKT 3 gamma 1(Ala 234-Ala 235), hyaluronic acid; Icatibant, imatinib mesylate, Indiplon, INKP-100, INKP-102, iodine (I131) tositumomab, istradefylline, IV gamma-globulin, ivabradine hydrochloride, ixabepilone; Lacosamide, landiolol, lanthanum carbonate, lasofoxifene tartrate, LB-80380, lenalidomide, lidocaine/tetracaine, linezolid, liposomal doxorubicin, liposomal vincristine sulfate, lopinavir, lopinavir/ritonavir, lumiracoxib, lurtotecan; Maribavir, morphine glucuronide, MVA-5 T

  2. Trial encoding algorithms ensemble.

    Science.gov (United States)

    Cheng, Lipin Bill; Yeh, Ren Jye

    2013-01-01

    This paper proposes trial algorithms for some basic components in cryptography and lossless bit compression. The symmetric encryption is accomplished by mixing up randomizations and scrambling with hashing of the key playing an essential role. The digital signature is adapted from the Hill cipher with the verification key matrices incorporating un-invertible parts to hide the signature matrix. The hash is a straight running summation (addition chain) of data bytes plus some randomization. One simplified version can be burst error correcting code. The lossless bit compressor is the Shannon-Fano coding that is less optimal than the later Huffman and Arithmetic coding, but can be conveniently implemented without the use of a tree structure and improvable with bytes concatenation.

  3. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    BACKGROUND: Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. AIM: To assess the efficacy...... of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using......: In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21)....

  4. The CYTONOX trial

    DEFF Research Database (Denmark)

    Gade, Christina; Mikus, Gerd; Christensen, Hanne Rolighed;

    2016-01-01

    INTRODUCTION: In Denmark, it is estimated that 3-5% of children are obese. Obesity is associated with pathophysiological alterations that may lead to alterations in the pharmacokinetics of drugs. In adults, obesity was found to influence important drug-metabolising enzyme pathways. The impact......, CYP2E1 and CYP1A2 in obese and non-obese children. The results are expected to be used in the future as a basis for drug dosing recommendations in obese children. FUNDING: The study was funded by the Danish Regions' "Medicinpuljen". The funder had no role in study design, data collection and analysis...... of obesity-related alterations on drug metabolism and its consequences for drug dosing remains largely unknown in both children and adults. An altered drug metabolism may contribute significantly to therapeutic failure or toxicity. The aim of this trial is to investigate the in vivo activity of CYP3A4, CYP2E...

  5. LTDNA Evidence on Trial

    Science.gov (United States)

    Roberts, Paul

    2016-01-01

    Adopting the interpretative/hermeneutical method typical of much legal scholarship, this article considers two sets of issues pertaining to LTDNA profiles as evidence in criminal proceedings. The section titled Expert Evidence as Forensic Epistemic Warrant addresses some rather large questions about the epistemic status and probative value of expert testimony in general. It sketches a theoretical model of expert evidence, highlighting five essential criteria: (1) expert competence; (2) disciplinary domain; (3) methodological validity; (4) materiality; and (5) legal admissibility. This generic model of expert authority, highlighting law's fundamentally normative character, applies to all modern forms of criminal adjudication, across Europe and farther afield. The section titled LTDNA Evidence in UK Criminal Trials then examines English and Northern Irish courts' attempts to get to grips with LTDNA evidence in recent cases. Better appreciating the ways in which UK courts have addressed the challenges of LTDNA evidence may offer some insights into parallel developments in other legal systems. Appellate court rulings follow a predictable judicial logic, which might usefully be studied and reflected upon by any forensic scientist or statistician seeking to operate effectively in criminal proceedings. Whilst each legal jurisdiction has its own unique blend of jurisprudence, institutions, cultures and historical traditions, there is considerable scope for comparative analysis and cross-jurisdictional borrowing and instruction. In the spirit of promoting more nuanced and sophisticated international interdisciplinary dialogue, this article examines UK judicial approaches to LTDNA evidence and begins to elucidate their underlying institutional logic. Legal argument and broader policy debates are not confined to considerations of scientific validity, contamination risks and evidential integrity, or associated judgments of legal admissibility or exclusion. They also crucially

  6. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998...

  7. Defendants' Rights in Criminal Trials.

    Science.gov (United States)

    Martin, Ralph C., II; Keeley, Elizabeth

    1997-01-01

    Reviews the protections afforded by the Constitution for defendants in criminal trials. These include the right to a jury trial (in cases of possible incarceration), an impartial jury, and the requirement of a unanimous verdict. Defends the use of plea bargaining as essential to an efficient criminal justice system. (MJP)

  8. Clinical Trials | Division of Cancer Prevention

    Science.gov (United States)

    Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |

  9. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    ... and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help researchers ... to HIV Can anyone participate in an HIV/AIDS clinical trial? It depends on the study. Some ...

  10. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  11. The Dynamo Clinical Trial

    Science.gov (United States)

    Ayres, Thomas R.

    2016-04-01

    The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)

  12. Trial analytics--a tool for clinical trial management.

    Science.gov (United States)

    Bose, Anindya; Das, Suman

    2012-01-01

    Prolonged timelines and large expenses associated with clinical trials have prompted a new focus on improving the operational efficiency of clinical trials by use of Clinical Trial Management Systems (CTMS) in order to improve managerial control in trial conduct. However, current CTMS systems are not able to meet the expectations due to various shortcomings like inability of timely reporting and trend visualization within/beyond an organization. To overcome these shortcomings of CTMS, clinical researchers can apply a business intelligence (BI) framework to create Clinical Research Intelligence (CLRI) for optimization of data collection and analytics. This paper proposes the usage of an innovative and collaborative visualization tool (CTA) as CTMS "add-on" to help overwhelm these deficiencies of traditional CTMS, with suitable examples.

  13. Acute Stroke | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available n(s) being investigated Acute Stroke MedDRA Classification E.1.3Condition being s... General Information on the Trial E.1 Medical condition or disease under investigation E.1.1Medical conditio

  14. 氨甲环酸联合Q开关Nd∶YAG激光治疗黄褐斑疗效观察%Efifcacy of oral tranexamic acid combined with low-lfuence 1064 nm Q-switched Nd:YAG laser in the treatment of melasma

    Institute of Scientific and Technical Information of China (English)

    安彩霞; 向芳; 杨珊; 普雄明

    2015-01-01

    ObjectiveTo evaluate the efficacy and safety of oral tranexamic acid (TA) combined with low-fluence 1064nm Q-switched Nd:YAG laser in the treatment of melasma. MethodsFifty-seven patients with melasma were enrolled in the study and randomly divided into two groups: a combination group and a laser treatment group. All the patients were treated with low-lfuence Nd:YAG laser, meanwhile TA was taken orally by the patients in the combination group lasted for 12 weeks. The degree of improvement in pigmentation was reassessed on 4, 8 and 12 weeks after treatment by melasma area severity index (MASI) scores. Side-effects, if any, were also recorded.ResultsThe MASI scores were decreased with the process of the treatment. Two groups showed signiifcant difference on 8 and 12 weeks after treatment (P<0.05). No serious adverse effects had been found.ConclusionOral TA in combination with low-lfuence Nd:YAG laser may be a safe and efifcient treatment option for melasma.%目的:研究口服氨甲环酸联合Q开关Nd∶YAG激光治疗黄褐斑的临床疗效和安全性。方法57例黄褐斑患者随机分为试验组和对照组,试验组在接受Nd∶YAG激光治疗的同时口服氨甲环酸片12周,对照组仅接受Nd∶YAG激光治疗。治疗后4、8、12周对患者进行黄褐斑皮损面积和严重度指数(MASI)评分,观察临床治疗效果并记录不良反应。结果随着治疗时间增加,患者的MASI评分逐渐下降。治疗后8周、12周,试验组和对照组患者MASI评分比较差异有统计学意义(P<0.05)。两组患者无明显不良反应发生。结论 Q开关Nd∶YAG激光联合氨甲环酸口服治疗黄褐斑安全有效,且不良反应少。

  15. Bayes' postulate for trinomial trials

    Science.gov (United States)

    Diniz, M. A.; Polpo, A.

    2012-10-01

    In this paper, we discuss Bayes' postulate and its interpretation. We extend the binomial trial method proposed by de Finetti [1] to trinomial trials, for which we argue that the consideration of equiprobability a priori for the possible outcomes of the trinomial trials implies that the parameter vector has Dirichlet(1,1) as prior. Based on this result, we agree with Stigler [2] in that the notion in Bayes' postulate stating "absolutely know nothing" is related to the possible outcomes of an experiment and not to "non-information" about the parameter.

  16. Modelling trial-by-trial changes in the mismatch negativity.

    Directory of Open Access Journals (Sweden)

    Falk Lieder

    Full Text Available The mismatch negativity (MMN is a differential brain response to violations of learned regularities. It has been used to demonstrate that the brain learns the statistical structure of its environment and predicts future sensory inputs. However, the algorithmic nature of these computations and the underlying neurobiological implementation remain controversial. This article introduces a mathematical framework with which competing ideas about the computational quantities indexed by MMN responses can be formalized and tested against single-trial EEG data. This framework was applied to five major theories of the MMN, comparing their ability to explain trial-by-trial changes in MMN amplitude. Three of these theories (predictive coding, model adjustment, and novelty detection were formalized by linking the MMN to different manifestations of the same computational mechanism: approximate Bayesian inference according to the free-energy principle. We thereby propose a unifying view on three distinct theories of the MMN. The relative plausibility of each theory was assessed against empirical single-trial MMN amplitudes acquired from eight healthy volunteers in a roving oddball experiment. Models based on the free-energy principle provided more plausible explanations of trial-by-trial changes in MMN amplitude than models representing the two more traditional theories (change detection and adaptation. Our results suggest that the MMN reflects approximate Bayesian learning of sensory regularities, and that the MMN-generating process adjusts a probabilistic model of the environment according to prediction errors.

  17. LTDNA Evidence on Trial

    Directory of Open Access Journals (Sweden)

    Paul Roberts

    2016-10-01

    factfinders in criminal trials.

  18. National Lung Screening Trial (NLST)

    Science.gov (United States)

    The National Lung Screening Trial (NLST), a research study sponsored by the National Cancer Institute that used low-dose helical CT scans or chest X-ray to screen men and women at risk for lung cancer.

  19. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Cancer Research and Discovery Stories of Discovery R&D Resources Conducting Clinical Trials Statistical Tools and Data ... about some of NCI's major research initiatives R&D Resources Tools and data sets for researchers Research ...

  20. What Are Clinical Trial Phases?

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    Full Text Available ... Bladder Cancer Breast Cancer Colorectal Cancer Kidney (Renal Cell) Cancer Leukemia Liver Lung Cancer Lymphoma Pancreatic Cancer ... Therapy Chemotherapy Immunotherapy Targeted Therapy Hormone Therapy Stem Cell Transplant Precision Medicine Side Effects Clinical Trials Information ...

  1. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Report (RPPR) Grant Closeout Grant Resources NCI Grants Management Legal Requirements NCI Grant Policies Grants Management Contacts ...

  2. What Are Clinical Trial Phases?

    Science.gov (United States)

    ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Report (RPPR) Grant Closeout Grant Resources NCI Grants Management Legal Requirements NCI Grant Policies Grants Management Contacts ...

  3. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Contacts Other Funding Find NCI funding for small business innovation, technology transfer, and contracts Training Cancer Training ...

  4. Q开关1064nm激光联合氨甲环酸治疗黄褐斑临床观察%Clinical efficacy of using Q-switch 1 064 nm combined with tranexamic acid clinical observation for the treatment of malasma

    Institute of Scientific and Technical Information of China (English)

    黄惠真; 李伟; 胡丽; 马刚; 陈辉; 陈锦安; 林晓曦

    2015-01-01

    目的:探讨单纯运用Q开关1064nm激光与联合口服氨甲环酸片治疗黄褐斑的疗效及安全性。方法:将36例确诊为黄褐斑的患者随机平均分为A、B两组。A组:采用Q开关1064nm Nd:YAG激光联合口服氨甲环酸片治疗;B组:单纯激光治疗。激光治疗间隔为4周,共8次,光斑直径6mm,能量密度3.0~3.5J/cm2,脉冲频率10Hz;氨甲环酸片每日2次,每次250mg,连续口服6个月。治疗过程中记录不良反应,由两位医师对每次治疗前及疗程结束后1个月照片进行mMASI评分,同时患者接受满意度调查,并进行相关统计学分析。结果:A、B两组间治疗前后的mMASI评分下降率有统计学差异(P<0.05),A组患者平均起效时间为2.47个月,B组为4.69个月;A组患者满意率72.22%,B组患者满意率61.11%,两组间满意率比较有统计学差异(P<0.05)。所有激光治疗患者未见严重不良反应,口服氨甲环酸片的患者中有1例胃肠道反应,1例患者自觉月经量减少。结论:口服氨甲环酸片联合Q开关1064nm激光治疗黄褐斑与单纯激光治疗相比,具有起效快、疗效高等优点。%Objective To compare the clinical efficacy and safety of using Medlite C6 Q-switch Nd:YAG Iaser and combined with tranexamic acid for the treatment of melasma. Method 36 female patients with melasma were divided into two groups,A and B,n=18.Group A were given Q-switch Nd:YAG 1 064nm laser every 4 weeks for 8 times,6mm spot,3.0-3.5J/cm2 energy,combined with oral tranexamic acid tablets for 6 month,500mg/day,twice a day.While group B were only treated with laser. The side effects were recorded and therapeutic efficacy were assessed by mMASI score and patient satisfaction rates. Result Both groups had achieved significant decrease from base line in mMASI score.Satisfaction rate of group A was 72.22%,while in group B it was 61.11%,there were statistically significant between the two groups

  5. Acute Schizophrenia | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available nter, Randomized, Double-blind, Placebo-controlled Trial of Three Fixed Doses of OPC-34712 in the Treatment of Adults With Acute...2 in the Treatment of Adults With Acute Schizophrenia A.4.1Sponsor's protocol code number331-10-231 A.5.2US ... Information on the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...ition or disease under investigation E.1.2Version 14.1 E.1.2Level LLT E.1.2Classification code 10001064 E.1.2Term Acute

  6. Acute Schizophrenia | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available 2, and 1 mg/day) in the Treatment of Adults With Acute Schizophrenia A.3.1Title ...of the trial for lay people, in easily understood, i.e. non-technical, language Efficacy Study of OPC-34712 in Adults With Acute...e Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...nder investigation E.1.2Version 14.0 E.1.2Level LLT E.1.2Classification code 10001064 E.1.2Term Acute schizo

  7. Design, analysis, and presentation of crossover trials

    Directory of Open Access Journals (Sweden)

    Guyatt Gordon H

    2009-04-01

    Full Text Available Abstract Objective Although crossover trials enjoy wide use, standards for analysis and reporting have not been established. We reviewed methodological aspects and quality of reporting in a representative sample of published crossover trials. Methods We searched MEDLINE for December 2000 and identified all randomized crossover trials. We abstracted data independently, in duplicate, on 14 design criteria, 13 analysis criteria, and 14 criteria assessing the data presentation. Results We identified 526 randomized controlled trials, of which 116 were crossover trials. Trials were drug efficacy (48%, pharmacokinetic (28%, and nonpharmacologic (30%. The median sample size was 15 (interquartile range 8–38. Most (72% trials used 2 treatments and had 2 periods (64%. Few trials reported allocation concealment (17% or sequence generation (7%. Only 20% of trials reported a sample size calculation and only 31% of these considered pairing of data in the calculation. Carry-over issues were addressed in 29% of trial's methods. Most trials reported and defended a washout period (70%. Almost all trials (93% tested for treatment effects using paired data and also presented details on by-group results (95%. Only 29% presented CIs or SE so that data could be entered into a meta-analysis. Conclusion Reports of crossover trials frequently omit important methodological issues in design, analysis, and presentation. Guidelines for the conduct and reporting of crossover trials might improve the conduct and reporting of studies using this important trial design.

  8. Clinical trials on AIDS start.

    Science.gov (United States)

    A 6-month clinical trial in the Philippines sought to determine the efficacy of coconut oil and of "monolaurin," a coconut oil byproduct, in killing HIV by breaking down its coating. This research is based on the theory that medium-chain fatty acids, like monolaurin, can have this effect on certain viruses. The trial involves 12 women and 3 men in the early stage of HIV infection. 10 patients will take different doses of monolaurin, and 5 will consume coconut oil. It is hypothesized that the regimen will lead to higher CD4 counts and a lower viral load. The trial was almost abandoned because it received only lukewarm approval from the Health Secretary.

  9. [Reading a clinical trial report].

    Science.gov (United States)

    Bergmann, J F; Chassany, O

    2000-04-15

    To improve medical knowledge by reading clinical trial reports it is necessary to check for the respect of the methodological rules, and to analyze and criticize the results. A control group and a randomisation are always necessary. Double blind assessment, sample size calculation, intention to treat analysis, a unique primary end point are also important. The conclusions of the trial are valid only for the population included and the clinical signification of the results, depending on the control treatment, has to be evaluated. Respect of the reading rules is necessary to assess the reliability of the conclusions, in order to promote evidence-based practice.

  10. Innovations in clinical trials informatics.

    Science.gov (United States)

    Summers, Ron; Vyas, Hiten; Dudhal, Nilesh; Doherty, Neil F; Coombs, Crispin R; Hepworth, Mark

    2008-01-01

    This paper will investigate innovations in information management for use in clinical trials. The application typifies a complex, adaptive, distributed and information-rich environment for which continuous innovation is necessary. Organisational innovation is highlighted as well as the technical innovations in workflow processes and their representation as an integrated set of web services. Benefits realization uncovers further innovations in the business strand of the work undertaken. Following the description of the development of this information management system, the semantic web is postulated as a possible solution to tame the complexity related to information management issues found within clinical trials support systems.

  11. Acute pancreatitis | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available lot Trial of Indomethacin in Acute Pancreatitis Ensayo piloto controlado y aleatorizado con indometacina en ....1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...n criteria Patients ages 18 or above admitted to hospital with a diagnosis of Acute pancreatitis (AP) based

  12. Acute Rhinosinusitis | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available edical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute Rhinosinu....2.3Trial contains a sub-study No E.3Principal inclusion criteria 1. Adult male and female outpatients aged ≥ 18 - 75 years 2. Acute

  13. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram;

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...... variable. Generation of trial databases and/or biobanks originating in large randomized clinical trials has successfully increased the knowledge obtained from those trials. At the 10th Cardiovascular Trialist Workshop, possibilities and pitfalls in designing and accessing clinical trial databases were......, in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  14. Clinical Trials in Your Community

    Science.gov (United States)

    The NCI Community Oncology Research Program (NCORP) is a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP conducts multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States and Puerto Rico.

  15. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian

    2007-01-01

    Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have addit...

  16. What Are Clinical Trial Phases?

    Medline Plus

    Full Text Available ... Questions to Ask about Your Diagnosis Research Cancer Treatment Types of Cancer Treatment Side Effects Clinical Trials Information A to Z ... Alternative Medicine (CAM) Questions to Ask about Your Treatment Research Coping with Cancer Feelings and Cancer Adjusting ...

  17. Glossary of Clinical Trials Terms

    Science.gov (United States)

    ... National Institutes of Health grant numbers. (See also Secondary IDs data element on ClinicalTrials.gov.) OUTCOME MEASURE A planned ... and Secondary Outcome Measure . (See also Primary and Secondary Outcome Measures data element and Outcome Measure results data element on ...

  18. Clinical Trials: Key to Medical Progress

    Science.gov (United States)

    Skip Navigation Bar Home Current Issue Past Issues Clinical Trials: Key to Medical Progress Past Issues / Summer 2008 ... this page please turn Javascript on. Photo iStock Clinical trials are research studies that test how well new ...

  19. New Eczema Drug Promising in Early Trial

    Science.gov (United States)

    ... page: https://medlineplus.gov/news/fullstory_163883.html New Eczema Drug Promising in Early Trial Nemolizumab significantly ... the appearance of moderate to severe eczema, a new, preliminary trial finds. Nemolizumab is a man-made, ...

  20. Acute Gout | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute Gou...t E.1.1.1Medical condition in easily understood language Acute Gout E.1.1.2Therapeutic area Diseases [C] - M...n the trial (if it is different from the expected normal treatment of that condition) Acute gout is a self l

  1. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.

  2. The Design of Cluster Randomized Crossover Trials

    Science.gov (United States)

    Rietbergen, Charlotte; Moerbeek, Mirjam

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own control. In a CR CO trial, clusters of subjects…

  3. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...

  4. Trial-to-Trial Fluctuations in Attentional State and Their Relation to Intelligence

    Science.gov (United States)

    Unsworth, Nash; McMillan, Brittany D.

    2014-01-01

    Trial-to-trial fluctuations in attentional state while performing measures of intelligence were examined in the current study. Participants performed various measures of fluid and crystallized intelligence while also providing attentional state ratings prior to each trial. It was found that pre-trial attentional state ratings strongly predicted…

  5. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C

    2016-07-01

    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  6. Medical coding in clinical trials

    Directory of Open Access Journals (Sweden)

    Deven Babre

    2010-01-01

    Full Text Available Data generated in all clinical trial are recorded on the data collection instrument Case report Form / Electronic Case Report Form by investigators located at various sites in various countries. In multicentric clinical trials since different investigator or medically qualified experts are from different sites / centers recording the medical term(s uniformly is a big challenge. Medical coders from clinical data management team process these terms and perform medical coding. Medical coding is performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed. This article describes process which is used for medical coding in clinical data management and two most commonly used medical dictionaries MedDRA and WHO-DDE in brief. It is expected to help medical coders to understand the process of medical coding in clinical data management. Few common issues which the medical coder faces while performing medical coding, are also highlighted.

  7. GPON FTTH trial: lessons learned

    Science.gov (United States)

    Weis, Erik; Hölzl, Rainer; Breuer, Dirk; Lange, Christoph

    2009-11-01

    This paper reports on a FTTH field trial with GPON (Gigabit-capable passive optical network) technology in the network of Deutsche Telekom in the region of the cities of Berlin and Potsdam. Focus of this trial was to gain practical experience regarding GPON technology, fibre installation in existing ducts with micro duct technology, fibre cabling in customer buildings and impact on operational processes. Furthermore it is reported on an initial Deutsche Telekom FTTB deployment based on GPON technology in the city of Dresden with the main targets to obtain practical deployment and operation experiences with fibre-based access networks and to provide broadband access to a part of the city formerly not servable by DSL (digital subscriber line) technology.

  8. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  9. The DiaS trial

    DEFF Research Database (Denmark)

    Andreasson, Kate; Krogh, Jesper; Rosenbaum, Bent

    2014-01-01

    BACKGROUND: In Denmark 8,000 to 10,000 people will attempt suicide each year. The Centre of Excellence in Suicide Prevention in the Capital Region of Denmark is treating patients with suicidal behavior, and a recent survey has shown that 30% of the patients are suffering from borderline personali...... measured at week 28. Other exploratory outcomes are included such as severity of symptoms, suicide intention and ideation, depression, hopelessness, self-esteem, impulsivity, anger, and duration of respective treatments. TRIAL REGISTRATION: Clinical Trial.gov: NCT01512602....... disorder. The majority of patients (70% to 75%) with borderline personality disorder have a history of deliberate self-harm and 10% have a lifetime risk to die by suicide. The DiaS trial is comparing dialectical behavior therapy with collaborative assessment and management of suicidality......-informed supportive psychotherapy, for the risk of repetition of deliberate self-harm in patients with a recent suicide attempt and personality traits within the spectrum of borderline personality disorder. Both treatments have previously shown effects in this group of patients on suicide ideation and self...

  10. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian

    2017-01-03

    The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.

  11. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    OpenAIRE

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-01-01

    Background To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. Methods The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, p...

  12. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    OpenAIRE

    Cihoric, Nikola; Tsikkinis, Alexandros; Gutierrez Miguelez, Cristina; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-01-01

    Background To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. Methods The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type,...

  13. Data monitoring committees for pragmatic clinical trials.

    Science.gov (United States)

    Ellenberg, Susan S; Culbertson, Richard; Gillen, Daniel L; Goodman, Steven; Schrandt, Suzanne; Zirkle, Maryan

    2015-10-01

    In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical

  14. Prehospital Tranexamic Acid Use for Traumatic Brain Injury

    Science.gov (United States)

    2015-10-01

    incidence of post - traumatic stress disorder and suicide .112 Efforts to treat TBI in the field include avoiding hypotension and secondary brain injury...378-384. 19 Harhangi BS, Kompanje JO, Leebeek FWG, et al. Coagulation disorders after traumatic brain injury. Acta Neurochir. 2008;150;165-175...K, Xu X-M. MicroRNA in central nervous system trauma and degenerative disorders . Physiol Genomics. 2011;43:571-580. 37. Hoyt DB. Post hoc ergo

  15. Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database

    Science.gov (United States)

    Subherwal, Sumeet; Patel, Manesh R.; Chiswell, Karen; Tidemann-Miller, Beth A.; Jones, W. Schuyler; Conte, Michael S.; White, Christopher J.; Bhatt, Deepak L.; Laird, John R.; Hiatt, William R.; Tasneem, Asba; Califf, Robert M.

    2014-01-01

    Background Tremendous advances have occurred in therapies for peripheral vascular disease (PVD); however, until recently it has not been possible to examine the entire clinical trial portfolio of studies for treatment of PVD (both arterial and venous disease). Methods and Results We examined interventional trials registered in ClinicalTrials.gov from October 2007 through September 2010 (n=40,970) and identified 676 (1.7%) PVD trials (n=493 arterial only, n=170 venous only, n=13 both arterial and venous). Most arterial studies investigated lower extremity peripheral artery disease and acute stroke (35% and 24%, respectively), while most venous studies examined deep vein thrombosis/pulmonary embolus prevention (42%) or venous ulceration (25%). A placebo-controlled trial design was used in 27% of the PVD trials, and 4% of the PVD trials excluded patients aged >65 years. Enrollment in at least 1 US site decreased from 51% in 2007 to 41% of trials in 2010. Compared with non-cardiology disciplines, PVD trials were more likely to be double-blinded, investigate use of devices and procedures, and have industry sponsorship and assumed funding source, and less likely to investigate drug and behavioral therapies. Geographic access to PVD clinical trials within the United States is limited to primarily large metropolitan areas. Conclusions PVD studies represent a small group of trials registered in ClinicalTrials.gov, despite the high prevalence of vascular disease in the general population. This low number, compounded by the decreasing number of PVD trials in the United States, is concerning and may limit the ability to inform current clinical practice of patients with PVD. PMID:25239436

  16. Microbicide clinical trial adherence: insights for introduction

    Directory of Open Access Journals (Sweden)

    Cynthia Woodsong

    2013-04-01

    Full Text Available After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1 Adherence measurement in clinical trials, (2 Comprehension of use instructions/Instructions for use, (3 Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4 Partner influence on use, (5 Retention and continuation and (6 Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  17. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  18. Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform.

    Science.gov (United States)

    Treweek, Shaun; Altman, Doug G; Bower, Peter; Campbell, Marion; Chalmers, Iain; Cotton, Seonaidh; Craig, Peter; Crosby, David; Davidson, Peter; Devane, Declan; Duley, Lelia; Dunn, Janet; Elbourne, Diana; Farrell, Barbara; Gamble, Carrol; Gillies, Katie; Hood, Kerry; Lang, Trudie; Littleford, Roberta; Loudon, Kirsty; McDonald, Alison; McPherson, Gladys; Nelson, Annmarie; Norrie, John; Ramsay, Craig; Sandercock, Peter; Shanahan, Daniel R; Summerskill, William; Sydes, Matt; Williamson, Paula; Clarke, Mike

    2015-06-05

    Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge ( www.trialforge.org ) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants' views on the processes in the life of a randomised trial that should be covered by Trial Forge.General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a 'go to' website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence.

  19. a randomized controlled clinical trial

    OpenAIRE

    2013-01-01

    In this study we aimed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a randomized clinical trial. 77 with chronic neck pain who scored > 40 mm on a 100-mm visual analog scale (VAS) were randomized to a nine week Iyengar yoga program with weekly 90-minute classes or to a self-care/exercise program. The primary outcome measure was change of mean pain at rest (VAS) from baseline to week ten. Secondary outcomes included pain at motion, functional disabilit...

  20. Juvenile Competency to Stand Trial.

    Science.gov (United States)

    Stepanyan, Sofia T; Sidhu, Shawn S; Bath, Eraka

    2016-01-01

    Competency to stand trial is interpreted as a protected due process right for all defendants and is defined as a defendant's fundamental knowledge and understanding of the criminal charges being filed, roles and procedures within the courtroom, and a general ability to work with the defense counsel. Questions of competency are most often raised by the judge, defense, or the prosecution, and competency evaluations are most often completed by psychiatrists or psychologists with forensic training or work experience. Mental illness, intellectual disability, developmental disorders, and developmental immaturity are the 4 main factors considered in most juvenile competency evaluations.

  1. Legislation for trial registration and data transparency.

    Science.gov (United States)

    Bian, Zhao-Xiang; Wu, Tai-Xiang

    2010-05-26

    Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement.Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.

  2. Some ethical implications of "adaptive" trials.

    Science.gov (United States)

    Petrini, C

    2015-01-01

    Adaptive trials are a new type of sequential trial, as yet not very widespread, in which each step can be modified on the basis of findings from the preceding step. In other words, the data accumulated during the study are used to modify the trial design. The potential of this type of trial is highly promising, especially for the development of therapies for rare diseases. The planning, conduct and management of data from adaptive trials are extremely complex processes and call for highly specialised skills. Without going into the merits of the experimental protocols, the aim of this article is to point out some ethical aspects that call for caution, as well as the need for ethics committees to be aware of the challenges posed by these trials.

  3. The FIB-PPH trial

    DEFF Research Database (Denmark)

    Wikkelsoe, Anne J; Afshari, Arash; Stensballe, Jakob;

    2012-01-01

    ABSTRACT: BACKGROUND: Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality worldwide. In Denmark 2 % of parturients receive blood transfusion. During the course of bleeding fibrinogen (coagulation factor I) may be depleted and fall to critically low levels impairing haemosta......ABSTRACT: BACKGROUND: Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality worldwide. In Denmark 2 % of parturients receive blood transfusion. During the course of bleeding fibrinogen (coagulation factor I) may be depleted and fall to critically low levels impairing...... haemostasis and thus worsening the ongoing bleeding. A plasma level of fibrinogen below 2 g/L in the early phase of postpartum haemorrhage is associated with subsequent development of severe haemorrhage. Use of fibrinogen concentrate allows high-dose substitution without the need for blood type cross match....... So far no publications of randomised controlled trials involving acutely bleeding patients in the obstetrical setting have been published. This trial aims to investigate if early treatment with fibrinogen concentrate reduces the need for blood transfusion in women suffering severe PPH. METHODS...

  4. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Science.gov (United States)

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

    2015-05-01

    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well.

  5. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Directory of Open Access Journals (Sweden)

    Joseph S Ross

    2009-09-01

    Full Text Available BACKGROUND: ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication. METHODS AND FINDINGS: We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006. CONCLUSIONS: Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low

  6. Design, Analysis, and Presentation of Crossover Trials

    OpenAIRE

    Guyatt Gordon H; Vail Andy; Wu Ping; Chan An-Wen; Mills Edward J; Altman Douglas G

    2009-01-01

    Abstract Objective Although crossover trials enjoy wide use, standards for analysis and reporting have not been established. We reviewed methodological aspects and quality of reporting in a representative sample of published crossover trials. Methods We searched MEDLINE for December 2000 and identified all randomized crossover trials. We abstracted data independently, in duplicate, on 14 design criteria, 13 analysis criteria, and 14 criteria assessing the data presentation. Results We identif...

  7. Ethics, Error, and Initial Trials of Efficacy

    OpenAIRE

    Hey, Spencer Phillips; Kimmelman, Jonathan

    2013-01-01

    Concerns about the frequency of failure in late stage drug development have prompted a series of proposals for improving the positive predictivity of trials where clinical activity is first evaluated—typically phase 2 trials. However, many proposed reforms entail ethical and social tradeoffs that might not be immediately apparent. We argue that trial reforms aimed at boosting phase 2 positive predictivity have important repercussions for human subjects, as well as the capacity of the research...

  8. Acute cough | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available ion E.1.1Medical condition(s) being investigated Acute cough Akuter Husten E.1.1.1Medical condition in easily understood language Acu...igation E.1.2Version 17.1 E.1.2Level LLT E.1.2Classification code 10066522 E.1.2Term Acute cough E.1.2System...igible for inclusion in this trial must fulfill all of the following criteria:1. Acute cough with symptoms l...based on medical history and physical examination7. CS score of at least 50 mm on a 100 mm VAS at V1 8. Acute...te cough Akuter Husten E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Dis

  9. Uncertainty and the ethics of clinical trials.

    Science.gov (United States)

    Hansson, Sven Ove

    2006-01-01

    A probabilistic explication is offered of equipoise and uncertainty in clinical trials. In order to be useful in the justification of clinical trials, equipoise has to be interpreted in terms of overlapping probability distributions of possible treatment outcomes, rather than point estimates representing expectation values. Uncertainty about treatment outcomes is shown to be a necessary but insufficient condition for the ethical defensibility of clinical trials. Additional requirements are proposed for the nature of that uncertainty. The indecisiveness of our criteria for cautious decision-making under uncertainty creates the leeway that makes clinical trials defensible.

  10. How Experimental Trial Context Affects Perceptual Categorization

    Directory of Open Access Journals (Sweden)

    Thomas J Palmeri

    2015-02-01

    Full Text Available To understand object categorization, participants are tested in experiments often quite different from how people experience object categories in the real world. Learning and knowledge of categories is measured in discrete experimental trials, those trials may or may not provide feedback, trials appear one after another, after some fixed inter-trial interval, with hundreds of trials in a row, within experimental blocks with some structure dictated by the experimental design. In the real world, outside of certain educational and vocational contexts, opportunities to learn and use categories are intermixed over time with a whole multitude of intervening experiences. It is clear from any elementary understanding of human cognition that sequential effects matter, yet this understanding is often ignored, and categorization trials are often instead treated as independent events, immune to local trial context. In this perspective, we use some of our work to illustrate some of the consequences of the fact that categorization experiments have a particular trial structure. Experimental trial context can affect performance in category learning and categorization experiments in ways that can profoundly affect theoretical conclusions.

  11. [Situation analysis for drug clinical trial institutions].

    Science.gov (United States)

    Chen, Yin-Ying; Wu, Ping; Wang, Jie

    2014-08-01

    Drug clinical trial is an important link in the chain of new drug research and development. The results of drug discovery and development directly depend on the extent of standardization of clinical trials. Therefore, improving the quality of drug clinical trials is of great importance, and drug clinical trial institutions play a crucial role in the quality management of drug clinical trials. After years of development, the overall level of drug clinical trials has advanced rapidly in China, and a large number of clinical trials of traditional Chinese medicine have also been carried out. However, there is still a big gap between our country and developed countries. Therefore, for the construction and management of Chinese drug clinical trial institutions, there is still a long way to go. This study aims to analyze the current development of drug clinical trial institutions in China and explore the existing problems from three aspects, including current situations of institutional organization and management, regional and professional distributions, and quality control. And some suggestions are put forward finally, including support of traditional Chinese medicine, introduction of drug-risk management system, and construction of information management.

  12. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup

    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about...... Report trial. This result retrodicts a latent attentional state of the subject using the observed response from that particular trial and thus differs from other predictions made with TVA which are based on expected values of observed variables. We show an example of the result in single-trial analysis...

  13. Power analysis of trials with multilevel data

    CERN Document Server

    Moerbeek, Mirjam

    2015-01-01

    Power Analysis of Trials with Multilevel Data covers using power and sample size calculations to design trials that involve nested data structures. The book gives a thorough overview of power analysis that details terminology and notation, outlines key concepts of statistical power and power analysis, and explains why they are necessary in trial design. It guides you in performing power calculations with hierarchical data, which enables more effective trial design.The authors are leading experts in the field who recognize that power analysis has attracted attention from applied statisticians i

  14. Analysis of the first field trial

    OpenAIRE

    Mesa-Lao, Bartolomé; Carl, Michael

    2014-01-01

    In this work package, we evaluate the CASMACAT workbench in eld trials to study the use of the workbench in a real-world environment. We will also integrate the workbench into com- munity translation platforms and collect user activity data from both eld trials and volunteer translators. This Deliverable covers Tasks 6.1 and 6.2. Task 6.1: Field trials at translation agency. Three annual eld trials to evaluate the CASMACAT workbench in a real-world professional translatio...

  15. The impact of advertising patient and public involvement on trial recruitment:embedded cluster randomisedrecruitment trial

    OpenAIRE

    Hughes-Morley, Adwoa; Hann, Robert; Fraser , Claire; Meade, Oonagh; Lovell, Karina; Young, Bridget; Roberts, Christopher; Cree, Lindsey; More, Donna; O'Leary, Neil; Callaghan, Patrick; Waheed, Waquas; Bower, Peter

    2016-01-01

    BackgroundPatient and public involvement in research (PPIR) may improve trial recruitment rates, but it is unclear how. Where trials use PPIR to improve design and conduct, many do not communicate this clearly to potential participants. Better communication of PPIR might encourage patient enrolment, as trials may be perceived as more socially valid, relevant and trustworthy. We aimed to evaluate the impact on recruitment of directly advertising PPIR to potential trial participants.MethodsThis...

  16. Patient reported outcomes (PROs) in clinical trials: is 'in-trial' guidance lacking? a systematic review.

    OpenAIRE

    Kyte, DG; Draper, H; Ives, J.; Liles, C; Gheorghe, A.; Calvert, M

    2013-01-01

    BACKGROUND: Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting) and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this revie...

  17. Identification of additional trials in prospective trial registers for Cochrane systematic reviews.

    Directory of Open Access Journals (Sweden)

    Wynanda A van Enst

    Full Text Available BACKGROUND: Publication and selective outcome reporting bias are a threat to the validity of systematic reviews. Extensive searching for additional trials in prospective trial registers could reduce this problem. We have evaluated how authors of Cochrane systematic reviews currently make use of trial registers as an additional source for the identification of potentially eligible trials. METHODOLOGY/PRINCIPAL FINDINGS: We included 210 systematic Cochrane reviews of interventions published between 2008 and 2010 of which the protocol was first published in 2008. When prospective trial registers were searched we recorded the names of the register(s, the authors' motive(s and if they yielded any extra trials. In 80 reviews (38.1% the authors had searched in one or more prospective trial register(s of which 55% had searched in overlapping search portals and individual registers. Most frequently assessed were the MetaRegister (66.3% and Clinicaltrials.gov (60% which is in sharp contrast of other registers or portals like the WHO ICTRP Search Portal (20%. Reported motives to use registers were to identify ongoing trials (83.3%, to identify unpublished outcomes or trials (23.5%, to identify recently published trials (11.8%, or to identify any relevant trial (3.9%.In 28 reviews (35% the authors had selected (ongoing trials identified in trial registers as potentially eligible. DISCUSSION: Trial registers as an additional source of information are gaining acknowledgement amongst Cochrane reviewers. Nevertheless, searches seem to be inefficient as overlapping databases are frequently consulted, while the WHO ICTRP Search Portal that includes the data from all approved registers worldwide is being underused. Moreover, the emphasis is now on the identification of ongoing trials, although the prospective registers offer a broader potential. Further familiarity of registers and guidance how to search and to report will help to implement this as a common method

  18. Increasing recruitment to randomised trials: a review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Torgerson David J

    2006-07-01

    Full Text Available Abstract Background Poor recruitment to randomised controlled trials (RCTs is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective. Methods We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors. Results We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive. Conclusion Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.

  19. Type 2 diabetes mellitus | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available .2 Objective of the trial E.2.1Main objective of the trial The purpose of this trial is to demonstrate that dextromethorphan...– IMP) before and during an OGTT- For dextromethorphan: to assess whether a dose-dependency of PD exists-To

  20. A Public Trial De Novo

    DEFF Research Database (Denmark)

    Vedel, Jane Bjørn; Gad, Christopher

    2011-01-01

    ” where the grant and close(r) intermingling between industry and public research was prosecuted and defended. First, the authors address how the grant was framed in the media. Second, they redescribe the case by introducing new “evidence” that, because of this framing, did not reach “the court......This article addresses the concept of “industrial interests” and examines its role in a topical controversy about a large research grant from a private foundation, the Novo Nordisk Foundation, to the University of Copenhagen. The authors suggest that the debate took the form of a “public trial.......” The article ends with a discussion of some implications of the analysis, including that policy making, academic research, and public debates might benefit from more detailed accounts of interests and stakes....

  1. International Clinical Trials Registry Platform (ICTRP)

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    @@ Introduction The mission of the WHO Intemational Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.This will improve research transparency and will ultimately strengthen tha validity and value of the scientific evidence base.The registration of all interventional trials is a scientific, ethical and moral responsibility.

  2. The design of cluster randomized crossover trials

    NARCIS (Netherlands)

    Rietbergen, C.; Moerbeek, M.

    2011-01-01

    The inefficiency induced by between-cluster variation in cluster randomized (CR) trials can be reduced by implementing a crossover (CO) design. In a simple CO trial, each subject receives each treatment in random order. A powerful characteristic of this design is that each subject serves as its own

  3. Blinded trials taken to the test

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  4. Alien wavelength modeling tool and field trial

    DEFF Research Database (Denmark)

    Sambo, N.; Sgambelluri, A.; Secondini, M.

    2015-01-01

    A modeling tool is presented for pre-FEC BER estimation of PM-QPSK alien wavelength signals. A field trial is demonstrated and used as validation of the tool's correctness. A very close correspondence between the performance of the field trial and the one predicted by the modeling tool has been...

  5. National Lung Screening Trial Results: Fast Facts

    Science.gov (United States)

    On November 4, 2010, the NLST reported initial trial results, showing 20 percent fewer lung cancer deaths among trial participants screened with low-dose helical CT (also known as spiral CT) compared to those who got screened with chest X-rays.

  6. Trial Sequential Methods for Meta-Analysis

    Science.gov (United States)

    Kulinskaya, Elena; Wood, John

    2014-01-01

    Statistical methods for sequential meta-analysis have applications also for the design of new trials. Existing methods are based on group sequential methods developed for single trials and start with the calculation of a required information size. This works satisfactorily within the framework of fixed effects meta-analysis, but conceptual…

  7. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  8. Paperless clinical trials: Myth or reality?

    Directory of Open Access Journals (Sweden)

    Sandeep K Gupta

    2015-01-01

    Full Text Available There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.

  9. Paperless clinical trials: Myth or reality?

    Science.gov (United States)

    Gupta, Sandeep K

    2015-01-01

    There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process.

  10. Paperless clinical trials: Myth or reality?

    Science.gov (United States)

    Gupta, Sandeep K.

    2015-01-01

    There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler. But clinical trials are a complex process and the increased complexity leads to decreased efficiency. Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc., In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management. The adaptation of paperless processes may require major changes to existing procedures. But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework. Moreover, all major regulatory authorities also advocate adoption of paperless trial. But challenges still remain toward implementation of paperless clinical trial process. PMID:26288464

  11. Ethics of clinical trials in Nigeria

    Directory of Open Access Journals (Sweden)

    Patrick I Okonta

    2014-01-01

    Full Text Available The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  12. Why are clinical trials necessary in India?

    Directory of Open Access Journals (Sweden)

    Subramani Poongothai

    2014-01-01

    Full Text Available Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India about clinical trials is probably an exaggeration of facts. However, these points to the need for ensuring proper compliance with the regulatory norms and proper training of concerned personnel in good clinical practice (GCP. This will ensure that India continues to reap the benefits of clinical trials and also become a world leader in this field.

  13. Clinical Trials and the Role of the Oncology Clinical Trials Nurse.

    Science.gov (United States)

    Ness, Elizabeth A; Royce, Cheryl

    2017-03-01

    Clinical trials are paramount to improving human health. New trial designs and informed consent issues are emerging as a result of genomic profiling and the development of molecularly targeted agents. Many groups and individuals are responsible for ensuring the protection of research participants and the quality of the data produced. The specialty role of the clinical trials nurse (CTN) is critical to clinical trials. Oncology CTNs have competencies that can help guide their practice; however, not all oncology clinical trials are supervised by a nurse. Using the process of engagement, one organization has restructured oncology CTNs under a nurse-supervised model.

  14. Automated information extraction of key trial design elements from clinical trial publications.

    Science.gov (United States)

    de Bruijn, Berry; Carini, Simona; Kiritchenko, Svetlana; Martin, Joel; Sim, Ida

    2008-11-06

    Clinical trials are one of the most valuable sources of scientific evidence for improving the practice of medicine. The Trial Bank project aims to improve structured access to trial findings by including formalized trial information into a knowledge base. Manually extracting trial information from published articles is costly, but automated information extraction techniques can assist. The current study highlights a single architecture to extract a wide array of information elements from full-text publications of randomized clinical trials (RCTs). This architecture combines a text classifier with a weak regular expression matcher. We tested this two-stage architecture on 88 RCT reports from 5 leading medical journals, extracting 23 elements of key trial information such as eligibility rules, sample size, intervention, and outcome names. Results prove this to be a promising avenue to help critical appraisers, systematic reviewers, and curators quickly identify key information elements in published RCT articles.

  15. Clinical Trials: Information and Options for People with Mood Disorders

    Science.gov (United States)

    ... Releases & Announcements Public Service Announcements Partnering with DBSA Clinical Trials: Information and Options for People with Mood Disorders What are clinical trials? Clinical trials are research studies involving people, which ...

  16. Clinical Trials | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn JavaScript on. Feature: Clinical Trials Clinical Trials, A Healthier Future for All Past Issues / Fall ... in was reviewed by an IRB. Find a Clinical Trial Near You Health research takes place at hospitals, ...

  17. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian;

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  18. Justifying clinical trials for porcine islet xenotransplantation.

    Science.gov (United States)

    Ellis, Cara E; Korbutt, Gregory S

    2015-01-01

    The development of the Edmonton Protocol encouraged a great deal of optimism that a cell-based cure for type I diabetes could be achieved. However, donor organ shortages prevent islet transplantation from being a widespread solution as the supply cannot possibly equal the demand. Porcine islet xenotransplantation has the potential to address these shortages, and recent preclinical and clinical trials show promising scientific support. Consequently, it is important to consider whether the current science meets the ethical requirements for moving toward clinical trials. Despite the potential risks and the scientific unknowns that remain to be investigated, there is optimism regarding the xenotransplantation of some types of tissue, and enough evidence has been gathered to ethically justify clinical trials for the most safe and advanced area of research, porcine islet transplantation. Researchers must make a concerted effort to maintain a positive image for xenotransplantation, as a few well-publicized failed trials could irrevocably damage public perception of xenotransplantation. Because all of society carries the burden of risk, it is important that the public be involved in the decision to proceed. As new information from preclinical and clinical trials develops, policy decisions should be frequently updated. If at any point evidence shows that islet xenotransplantation is unsafe, then clinical trials will no longer be justified and they should be halted. However, as of now, the expected benefit of an unlimited supply of islets, combined with adequate informed consent, justifies clinical trials for islet xenotransplantation.

  19. Clinical trial registration in oral health journals.

    Science.gov (United States)

    Smaïl-Faugeron, V; Fron-Chabouis, H; Durieux, P

    2015-03-01

    Prospective registration of randomized controlled trials (RCTs) represents the best solution to reporting bias. The extent to which oral health journals have endorsed and complied with RCT registration is unknown. We identified journals publishing RCTs in dentistry, oral surgery, and medicine in the Journal Citation Reports. We classified journals into 3 groups: journals requiring or recommending trial registration, journals referring indirectly to registration, and journals providing no reference to registration. For the 5 journals with the highest 2012 impact factors in each group, we assessed whether RCTs with results published in 2013 had been registered. Of 78 journals examined, 32 (41%) required or recommended trial registration, 19 (24%) referred indirectly to registration, and 27 (35%) provided no reference to registration. We identified 317 RCTs with results published in the 15 selected journals in 2013. Overall, 73 (23%) were registered in a trial registry. Among those, 91% were registered retrospectively and 32% did not report trial registration in the published article. The proportion of trials registered was not significantly associated with editorial policies: 29% with results in journals that required or recommended registration, 15% in those that referred indirectly to registration, and 21% in those providing no reference to registration (P = 0.05). Less than one-quarter of RCTs with results published in a sample of oral health journals were registered with a public registry. Improvements are needed with respect to how journals inform and require their authors to register their trials.

  20. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  1. Analysis of the third field trial

    OpenAIRE

    Alabau, Vicent; Carl, Michael; Martínez, García, G.; González-Rubio, Jesús; Mesa-Lao, Bartolomé; Ortiz-Martínez, Daniel; Rodrigues,Sofia; Schaeffer, Moritz

    2014-01-01

    In this work package, we evaluate the CasMaCat workbench in eld trials to study the use of the workbench in a real-world environment. We have also integrated the workbench into community translation platforms and collected user activity data from both eld trials and volunteer translators interacting with the workbench. This Deliverable covers Task 6.1 and 6.2. Task 6.1: Third eld trial at a translation agency (Celer Soluciones SL in Madrid) to evaluate the CasMaCat work...

  2. Analysis of the second Field trial

    OpenAIRE

    Iglesias, Eva Marcos; Pellegrino, Massimiliano; Carl, Michael; García-Martínez, Mercedes; Mesa-Lao, Bartolomé; Underwood, Nancy

    2014-01-01

    In this work package, we evaluate the CasMaCat workbench in eld trials to study the use of the workbench in a real-world environment. We will also integrate the workbench into com- munity translation platforms and collect user activity data from both eld trials and volunteer translators. This Deliverable covers Tasks 6.1 and 6.2. Task 6.1: Three eld trials at a translation agency (Celer Soluciones SL)to evaluate the CasMaCat workbench in a real-world professional translat...

  3. Lessons Learned from Radiation Oncology Clinical Trials

    OpenAIRE

    Liu, Fei-Fei; Okunieff, Paul; Bernhard, Eric J.; Stone, Helen B.; Yoo, Stephen; Coleman, C. Norman; Vikram, Bhadrasain; Brown, Martin; Buatti, John; Guha, Chandan

    2013-01-01

    A Workshop entitled “Lessons Learned from Radiation Oncology Trials” was held on December 7–8th, 2011 in Bethesda, MD, to present and discuss some of the recently conducted Radiation Oncology clinical trials with a focus on those that failed to refute the null hypothesis. The objectives of this Workshop were to summarize and examine the questions that these trials provoked, to assess the quality and limitations of the pre-clinical data that supported the hypotheses underlying these trials, an...

  4. Pragmatic design in randomized controlled trials.

    Science.gov (United States)

    Purgato, M; Barbui, C; Stroup, S; Adams, C

    2015-01-01

    At more than 10 years after the paper by Hotopf and colleagues regarding pragmatic trials in psychiatry, the field has evolved and is evolving further. There have been many developments in our understanding of what pragmatism really means, and excellent examples of truly pragmatic trials in psychiatry are currently available. Funders have helped encourage more emphasis on the need for such studies, but 'local' and trans-national regulations could help more. Consumers of the evidence should have a greater voice in generating the research agenda and, as this happens, the questions generated are more likely to be answered by a pragmatic approach to trials.

  5. Provenance trials of larch in Siberia

    Energy Technology Data Exchange (ETDEWEB)

    Milyutin, L.I. [V.N. Sukachev Inst. of Forest SB RAS, Krasnoyarsk (Russian Federation)

    1995-12-31

    Some results of provenance trials of larch in Siberia are given. These provenance trials were established in the last thirty years by efforts of V.N. Sukaczev Inst. of Forest. Provenances and species of larch were tested in some field trials distributed over Siberia between Lat. N 52 deg and 66 deg, Long. E 88 deg and 113 deg: near Krasnoyarsk, in Republic Khakasia (an altitudes of 800 and 1200 metres), in the Lower Yenisei near Turukhansk, in the west and south regions of Krasnoyarsk territory, in the Upper Lena, near Chita. 2 refs

  6. [Dental extractions in patients taking anticoagulants: is alteration of the anticoagulant regime necessary?].

    Science.gov (United States)

    Madrid, Carlos

    2005-05-25

    A major concern in the management of patients under anticoagulants is the potential for excessive bleeding after dental procedures. Recommendations for the administration of oral anticoagulants in conjunction with oral surgery range from complete withdrawal of anticoagulants to the maintenance of an unchanged therapy. Rising evidences show that the alteration of anticoagulation is not necessary for patients with INR of 4 or less previous to tooth extractions. Topical antifibrinolytics as tranexamic acid control successfully alveolar bleeding. It is time to stop interrupting anticoagulant therapy for oral surgery. A theoretical risk of hemorrhage after dental surgery in patients at therapeutic levels of anticoagulation exists but it is minimal and is greatly overweighed by the risk of thromboembolism after alteration of the anticoagulant therapy.

  7. Ebola Vaccine Appears Very Effective in Trial

    Science.gov (United States)

    ... https://medlineplus.gov/news/fullstory_162715.html Ebola Vaccine Appears Very Effective in Trial Drug manufacturer says ... Dec. 23, 2016 (HealthDay News) -- An experimental Ebola vaccine was highly effective against the deadly virus in ...

  8. Smart Technology in Lung Disease Clinical Trials.

    Science.gov (United States)

    Geller, Nancy L; Kim, Dong-Yun; Tian, Xin

    2016-01-01

    This article describes the use of smart technology by investigators and patients to facilitate lung disease clinical trials and make them less costly and more efficient. By "smart technology" we include various electronic media, such as computer databases, the Internet, and mobile devices. We first describe the use of electronic health records for identifying potential subjects and then discuss electronic informed consent. We give several examples of using the Internet and mobile technology in clinical trials. Interventions have been delivered via the World Wide Web or via mobile devices, and both have been used to collect outcome data. We discuss examples of new electronic devices that recently have been introduced to collect health data. While use of smart technology in clinical trials is an exciting development, comparison with similar interventions applied in a conventional manner is still in its infancy. We discuss advantages and disadvantages of using this omnipresent, powerful tool in clinical trials, as well as directions for future research.

  9. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  10. Trials of electronet fencing to exclude coyotes

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This report is on the trials of using electronet fencing to exclude coyotes for the protection of black-footed ferrets in Montana. Reintroduction of black-tailed...

  11. Nutrition Intervention Trials in Linxian, China

    Science.gov (United States)

    Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population

  12. Citicoline for ischemic stroke: ICTUS trial

    Directory of Open Access Journals (Sweden)

    Vladimir Anatolyevich Parfenov

    2012-01-01

    Full Text Available The paper gives data available in the literature on the use of citicoline in an experimental model of ischemic stroke (IS and in randomized multicenter placebo-controlled trials. It analyzes the results of the ICTUS trial in which 2298 patients with IS who received randomly citicoline or placebo for 24 hours after the onset of symptoms (I000 mg intravenously every I2 hours during the first 3 days, then orally as one 500-mg tablet every 12 hours during 6 weeks. The results of the trial confirmed the safety of citicoline used in IS, but failed to show its significant advantage over placebo in reducing the degree of disability (global improvement 90 days later. However, to pool the results of the ICTUS trial with those of other randomized multicenter placebo-controlled studies demonstrates a significant decrease in the degree of disability in IS patients treated with citicoline.

  13. National Lung Screening Trial: Questions and Answers

    Science.gov (United States)

    ... Resources Conducting Clinical Trials Statistical Tools and Data Terminology Resources NCI Data Catalog Cryo-EM NCI's Role ... Report (RPPR) Grant Closeout Grant Resources NCI Grants Management Legal Requirements NCI Grant Policies Grants Management Contacts ...

  14. Narrating the Mensalão trial

    DEFF Research Database (Denmark)

    Damgaard, Mads

    2015-01-01

    Coming to a close in the last days of 2012, the trial of the so-called mensalão network was heralded as Brazil's trial of the century. Involving corruption in the top ranks of the business world and the former government, the process ended with an exceptional result in the sense that severe...... sentences were meted out to 25 of the 38 defendants, thereby breaking an established pattern of impunity for corrupt politicians in Brazilian courts. As a scandal potentially harmful for the governing party and the former president Luis “Lula” da Silva, the eyes and spotlights of the national media were...... fixed on the trial. However, the varying and contested ways in which the case was presented by media from the outbreak of the scandal in 2005 until the end of the trial bears witness to the fact that narratives concerning corruption scandals can potentially encompass a broad range of political...

  15. The unintended consequences of clinical trials regulations.

    Directory of Open Access Journals (Sweden)

    Alex D McMahon

    2009-11-01

    Full Text Available Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH guidance on good clinical practice (GCP, arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.

  16. The unintended consequences of clinical trials regulations

    OpenAIRE

    Alex D McMahon; Conway, David I; MacDonald, Tom M; McInnes, Gordon T

    2009-01-01

    Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.

  17. The PACT trial: PAtient Centered Telerehabilitation

    Directory of Open Access Journals (Sweden)

    Andreas Stefan Rothgangel

    2015-01-01

    Discussion: Several questions concerning the study design that emerged during the preparation of this trial will be discussed. This will include how these questions were addressed and arguments for the choices that were made.

  18. Population activity changes during a trial-to-trial adaptation of bullfrog retinal ganglion cells.

    Science.gov (United States)

    Ding, Wei; Xiao, Lei; Jing, Wei; Zhang, Pu-Ming; Liang, Pei-Ji

    2014-07-09

    A 'trial-to-trial adaptation' of bullfrog retinal ganglion cells in response to a repetitive light stimulus was investigated in the present study. Using the multielectrode recording technique, we studied the trial-to-trial adaptive properties of ganglion cells and explored the activity of population neurons during this adaptation process. It was found that the ganglion cells adapted with different degrees: their firing rates were decreased in different extents from early-adaptation to late-adaptation stage, and this was accompanied by a decrease in cross-correlation strength. In addition, adaptation behavior was different for ON-response and OFF-response, which implied that the mechanism of the trial-to-trial adaptation might involve bipolar cells and/or their synapses with other neurons and the stronger adaptation in the ganglion cells' OFF-responses might reflect the requirement to avoid possible saturation in the OFF circuit.

  19. Strength of Mock-up Trial Grout

    DEFF Research Database (Denmark)

    Sørensen, Eigil V.

    The present report describes tests carried out on samples taken and cast during the execution of a mock-up trial placement of the high performance grout MASTERFLOW 9500 on January 21, 2009.......The present report describes tests carried out on samples taken and cast during the execution of a mock-up trial placement of the high performance grout MASTERFLOW 9500 on January 21, 2009....

  20. Therapeutic trials for systemic sclerosis: An update

    Directory of Open Access Journals (Sweden)

    Sardana Kabir

    2008-01-01

    Full Text Available The pathogenesis of systemic sclerosis (SSc is complex, and the final story is yet to be elucidated. The clinical heterogeneity of the disease, its various autoimmune and antibody profiles, its long course and tendency for spontaneous cure makes the design of clinical trials difficult. The overwhelming need in this disease is to diagnose it early and identify those patients who will benefit most from early, aggressive treatment. We attempt to review data from recent clinical trials and the lessons derived.

  1. Phase 1 Trials in Pancreatic Cancer

    Directory of Open Access Journals (Sweden)

    Esther Yu

    2014-07-01

    Full Text Available Despite many clinical trials over the last two decades since the approval of gemcitabine, the survival of patients with pancreatic cancer has improved by a few only months. This disappointing reality underlines an urgent need to develop more effective drugs or better combinations. A variety of phase I trials were presented at the annual meeting of ASCO 2014 focusing on locally advanced and metastatic pancreatic cancer. We summarize four abstracts (abstracts #4116, #4123, #4026, #4138.

  2. Phase 1 Trials in Pancreatic Cancer

    OpenAIRE

    Esther Yu; Muhammad Wasif Saif; Kathryn Huber

    2014-01-01

    Despite many clinical trials over the last two decades since the approval of gemcitabine, the survival of patients with pancreatic cancer has improved by a few only months. This disappointing reality underlines an urgent need to develop more effective drugs or better combinations. A variety of phase I trials were presented at the annual meeting of ASCO 2014 focusing on locally advanced and metastatic pancreatic cancer. We summarize four abstracts (abstracts #4116, #4123, #4026, #4138).

  3. Trial geography, pharmacogenetics, and global drug development.

    Science.gov (United States)

    Schuck, R N; Florian, J; Charlab, R; Pacanowski, M

    2015-03-01

    Drug development is increasingly global. The benefits of multiregional trials include worldwide evaluation of safety and efficacy. However, clinical practice, environmental, and genetic factors can vary across geographic regions, significantly influencing trial outcomes within a specific geographic region or the global population relative to the United States (US). Genomic technologies and research discoveries continue to advance at a remarkable pace, offering opportunities to explore intrinsic factors that could account for regional variability in drug pharmacokinetics or response.

  4. Gulf War Illness Inflammation Reduction Trial

    Science.gov (United States)

    2015-10-01

    1 AWARD NUMBER: W81XWH-14-1-0477 TITLE: Gulf War Illness Inflammation Reduction Trial PRINCIPAL INVESTIGATOR: Ronald R. Bach, Ph.D...5a. CONTRACT NUMBER Gulf War Illness Inflammation Reduction Trial 5b. GRANT NUMBER W81XWH-14-1-0477 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d...GWI). Elevated biomarkers of inflammation were observed in our pilot observational study of GWI. Thus, chronic inflammation appears to be part of

  5. Razors versus clippers. A randomised controlled trial.

    Science.gov (United States)

    Taylor, Tracy; Tanner, Judith

    2005-12-01

    The purpose of this randomised controlled trial was to determine if patients showed a preference for preoperative hair removal with razors or clippers and to identify if one method was associated with more trauma or postoperative infections. The trial took place in a day surgery unit with patients who were having a range of surgical procedures including hernias and varicose veins. This study was sponsored by an award from the NATN/3M Clinical Fellowship.

  6. The Impact of Putting Mubarak on Trial

    Institute of Scientific and Technical Information of China (English)

    2011-01-01

    On August 3,2011,83-year-old former Egyptian President Hosni Mubarak was put on trial,lying on a hospital bed an iron cage in a Cairo courtroom. Zhang Zhongxiang,Deputy Director of the Department of the West Asian and African Studies at the Shanghai Institutes for International Studies,believes that the Mubarak trial will not only aggravate conflict among Egyptian people, but also complicate the regional tensions and

  7. Randomized controlled trials - a matter of design.

    Science.gov (United States)

    Spieth, Peter Markus; Kubasch, Anne Sophie; Penzlin, Ana Isabel; Illigens, Ben Min-Woo; Barlinn, Kristian; Siepmann, Timo

    2016-01-01

    Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

  8. From international to zonal trials: the origins of the Nuremberg medical trial.

    Science.gov (United States)

    Weindling, P

    2000-01-01

    This article examines how plans to have a second International Military Tribunal led to the Medical Trial at Nuremberg. While the British opposed a second international trial because of their distrust of the Soviets, they supported a plan for a series of special zonal trials to be conducted by the American authorities at Nuremberg. In December 1945 the British became aware of the extent of medical war crimes committed by the Germans. Their investigation led to an eventual handover to the Americans of a group of German doctors for trial at Nuremberg. At the same time the British and French Supported an International Scientific Commission for the Investigation of Medical War Crimes.

  9. UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Craig Fiona F

    2012-04-01

    Full Text Available Abstract Background Pyoderma gangrenosum (PG is a rare inflammatory skin disorder characterised by painful and rapidly progressing skin ulceration. PG can be extremely difficult to treat and patients often require systemic immunosuppression. Recurrent lesions of PG are common, but the relative rarity of this condition means that there is a lack of published evidence regarding its treatment. A systematic review published in 2005 found no randomised controlled trials (RCTs relating to the treatment of PG. Since this time, one small RCT has been published comparing infliximab to placebo, but none of the commonly used systemic treatments for PG have been formally assessed. The UK Dermatology Clinical Trials Network’s STOP GAP Trial has been designed to address this lack of trial evidence. Methods The objective is to assess whether oral ciclosporin is more effective than oral prednisolone for the treatment of PG. The trial design is a two-arm, observer-blind, parallel-group, randomised controlled trial comparing ciclosporin (4 mg/kg/day to prednisolone (0.75 mg/kg/day. A total of 140 participants are to be recruited over a period of 4 years, from up to 50 hospitals in the UK and Eire. Primary outcome of velocity of healing at 6 weeks is assessed blinded to treatment allocation (using digital images of the ulcers. Secondary outcomes include: (i time to healing; (ii global assessment of improvement; (iii PG inflammation assessment scale score; (iv self-reported pain; (v health-related quality of life; (vi time to recurrence; (vii treatment failures; (viii adverse reactions to study medications; and (ix cost effectiveness/utility. Patients with a clinical diagnosis of PG (excluding granulomatous PG; measurable ulceration (that is, not pustular PG; and patients aged over 18 years old who are able to give informed consent are included in the trial. Randomisation is by computer generated code using permuted blocks of randomly varying size

  10. The International "Trial of the 20th Century": Nuremberg.

    Science.gov (United States)

    Chemerinsky, Erwin

    1999-01-01

    Considers the Nuremberg trials to be the "Trial of the Century." Highlights the series of 13 trials in which Nazi leaders, officials, judges, and others were tried, and most convicted, for war crimes. Relates that these trials had far-reaching effects in that they showed that moral obligations transcend national boundaries. (CMK)

  11. Study of the trial subjects’ protection aspects in Phase I clinical trials and bioequivalence studies

    Directory of Open Access Journals (Sweden)

    K. O. Zupanets

    2016-03-01

    Full Text Available Protection of rights, health and well-being of persons who are taking the drug during the trial (trial subjects is one of the basic principles of clinical trials (CT management. Aim. In order to study key aspects of volunteer protection, determine factors that influence these indicators and estimate the importance of ensuring their proper implementation on the clinical site (CS three survey of 135 trial subjects were carried out to evaluate the importance of assessing the impact of factors such as the procedure of signing the informed consent (IC at the CS and testing procedures for HIV / AIDS, hepatitis and others. Assessment of the quality of life of trial subjects as indirect indicator of the quality of clinical trials that ensures the proper protection of their life was the subject of the third survey. Methods and results. The general model of the relationship between the key aspects of the trial subjects protection and the factors which are providing them during the clinical trials of drugs management was substantiated, which included the main aspects of the trial subjects’ protection, protective factors and basic CT management procedures, the impact of the above factors on the possibility of providing protection aspects depends on their implementation quality. It was found that trial subjects’ protection improvement can be achieved during the IC signing process. It is necessary to ensure a higher level of volunteers understanding of the terms that could be used in the IC form. Regarding the procedure of compulsory testing for HIV/AIDS in the course of screening, we can conclude that the majority of the trial subjects believe that this procedure is an additional factor in their health protection and do not consider it as an excessive psychological pressure on them. Conclusion. Assessing the quality of life during the bioequivalence study at the CS makes possible to reach a conclusion on general well-being and satisfaction with those

  12. Optimizing detector trials for humanitarian demining

    Science.gov (United States)

    Gaal, Mate; Baer, Sylke; Bloodworth, Thomas J.; Guelle, Dieter; Lewis, Adam M.; Mueller, Christina; Scharmach, Martina

    2004-09-01

    The performance of mine detecting instruments is embedded in the behavior of a complex system. The total reliability is always composed of the intrinsic physical detection capability of the sensor, application/environmental influences and human factors. The intrinsic capability and some application factors can be investigated in laboratory measurements. Human factors, other application factors and the overall reliability, can only be evaluated in blind field trials in which the probability of detection (PoD) and false alarm rate (FAR) are measured statistically. Both of these approaches are included in CEN Workshop Agreement CWA 14747:2003, which standardizes detector testing in Humanitarian Demining. We report here the results of a study to investigate how to optimize such testing. For efficient and statistically valid field trials, the number, types and burial depths of targets, and the number of test lanes, soil types, repetitions and operators need to be carefully chosen. Laboratory results should be used to help construct field trial protocols and also to help distinguish the different contributions to the PoD and FAR, to determine where to improve insufficient performance. In this study, four models of metal detector were tested in three field trials and in the laboratory. The repeatability of the field trials is assessed, taking into account operator training and experience. Results of the laboratory tests are compared with results of the field trials and used to construct a "modular model" of the system, as used in nondestructive testing. The conclusions are, in principle, applicable to trials of other types of sensor.

  13. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

    DEFF Research Database (Denmark)

    Gluud, Christian; Nikolova, Dimitrinka

    2007-01-01

    The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....

  14. Information on blinding in registered records of clinical trials

    Directory of Open Access Journals (Sweden)

    Viergever Roderik F

    2012-11-01

    Full Text Available Abstract Information on blinding is part of the data that should be provided upon registration of a trial at a clinical trials registry. Reporting of blinding is often absent or of low quality in published articles of clinical trials. This study researched the presence and quality of information on blinding in registered records of clinical trials and highlights the important role of data-recording formats at clinical trial registries in ensuring high-quality registration.

  15. Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

    Science.gov (United States)

    A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

  16. Acute Lung Injury | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available rnedUK - MHRA A.2EudraCT number2010-021186-70 A.3Full title of the trial Keratinocyte growth factor in Acute...reviated title of the trial where available Keratinocyte Growth Factor in Acute L...nder investigation E.1.1Medical condition(s) being investigated Acute Lung Injury

  17. The Trial of Napoleon: A Case Study for Using Mock Trials.

    Science.gov (United States)

    MacKay, Charles

    2000-01-01

    Describes a course entitled "The Trial of Napoleon Bonaparte" that focuses on a fictitious mock trial of Napoleon Bonaparte to answer the question: did Napoleon pervert or preserve the gain of the French Revolution? Discusses the strengths and weaknesses of the course. (CMK)

  18. Using e-technologies in clinical trials.

    Science.gov (United States)

    Rosa, Carmen; Campbell, Aimee N C; Miele, Gloria M; Brunner, Meg; Winstanley, Erin L

    2015-11-01

    Clinical trials have been slow to incorporate e-technology (digital and electronic technology that utilizes mobile devices or the Internet) into the design and execution of studies. In the meantime, individuals and corporations are relying more on electronic platforms and most have incorporated such technology into their daily lives. This paper provides a general overview of the use of e-technologies in clinical trials research, specifically within the last decade, marked by rapid growth of mobile and Internet-based tools. Benefits of and challenges to the use of e-technologies in data collection, recruitment and retention, delivery of interventions, and dissemination are provided, as well as a description of the current status of regulatory oversight of e-technologies in clinical trials research. As an example of ways in which e-technologies can be used for intervention delivery, a summary of e-technologies for treatment of substance use disorders is presented. Using e-technologies to design and implement clinical trials has the potential to reach a wide audience, making trials more efficient while also reducing costs; however, researchers should be cautious when adopting these tools given the many challenges in using new technologies, as well as threats to participant privacy/confidentiality. Challenges of using e-technologies can be overcome with careful planning, useful partnerships, and forethought. The role of web- and smartphone-based applications is expanding, and the increasing use of those platforms by scientists and the public alike make them tools that cannot be ignored.

  19. Quantitative Imaging in Cancer Clinical Trials.

    Science.gov (United States)

    Yankeelov, Thomas E; Mankoff, David A; Schwartz, Lawrence H; Lieberman, Frank S; Buatti, John M; Mountz, James M; Erickson, Bradley J; Fennessy, Fiona M M; Huang, Wei; Kalpathy-Cramer, Jayashree; Wahl, Richard L; Linden, Hannah M; Kinahan, Paul E; Zhao, Binsheng; Hylton, Nola M; Gillies, Robert J; Clarke, Laurence; Nordstrom, Robert; Rubin, Daniel L

    2016-01-15

    As anticancer therapies designed to target specific molecular pathways have been developed, it has become critical to develop methods to assess the response induced by such agents. Although traditional, anatomic CT, and MRI examinations are useful in many settings, increasing evidence suggests that these methods cannot answer the fundamental biologic and physiologic questions essential for assessment and, eventually, prediction of treatment response in the clinical trial setting, especially in the critical period soon after treatment is initiated. To optimally apply advances in quantitative imaging methods to trials of targeted cancer therapy, new infrastructure improvements are needed that incorporate these emerging techniques into the settings where they are most likely to have impact. In this review, we first elucidate the needs for therapeutic response assessment in the era of molecularly targeted therapy and describe how quantitative imaging can most effectively provide scientifically and clinically relevant data. We then describe the tools and methods required to apply quantitative imaging and provide concrete examples of work making these advances practically available for routine application in clinical trials. We conclude by proposing strategies to surmount barriers to wider incorporation of these quantitative imaging methods into clinical trials and, eventually, clinical practice. Our goal is to encourage and guide the oncology community to deploy standardized quantitative imaging techniques in clinical trials to further personalize care for cancer patients and to provide a more efficient path for the development of improved targeted therapies.

  20. Biomarkers in T cell therapy clinical trials

    Directory of Open Access Journals (Sweden)

    Kalos Michael

    2011-08-01

    Full Text Available Abstract T cell therapy represents an emerging and promising modality for the treatment of both infectious disease and cancer. Data from recent clinical trials have highlighted the potential for this therapeutic modality to effect potent anti-tumor activity. Biomarkers, operationally defined as biological parameters measured from patients that provide information about treatment impact, play a central role in the development of novel therapeutic agents. In the absence of information about primary clinical endpoints, biomarkers can provide critical insights that allow investigators to guide the clinical development of the candidate product. In the context of cell therapy trials, the definition of biomarkers can be extended to include a description of parameters of the cell product that are important for product bioactivity. This review will focus on biomarker studies as they relate to T cell therapy trials, and more specifically: i. An overview and description of categories and classes of biomarkers that are specifically relevant to T cell therapy trials, and ii. Insights into future directions and challenges for the appropriate development of biomarkers to evaluate both product bioactivity and treatment efficacy of T cell therapy trials.

  1. Public information about clinical trials and research.

    Science.gov (United States)

    Plétan, Yannick; Zannad, Faïez; Jaillon, Patrice

    2003-01-01

    Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: there is no need for additional legal or regulatory constraints; sponsors should be aware of and make use of direct public information on trials; a 'good practice charter' on public communication about clinical trials should be developed; all professionals should be involved in this communication platform; communication in the patient's immediate vicinity should be preferred (primary-care physician, local press); clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; media groups should receive at least some training in the fundamentals of clinical research.

  2. Prostate cancer vaccines in clinical trials.

    Science.gov (United States)

    Lubaroff, David M

    2012-07-01

    This review presents important information about the current state of the art for vaccine immunotherapy of prostate cancer. It includes important preclinical research for each of the important prostate cancer vaccines to have reached clinical trials. To date, the only prostate cancer vaccine that has completed Phase III trials and has been approved and licensed by the US FDA is Sipuleucel-T, which immunizes patients against the prostate-associated antigen prostatic acid phosphatase. The benefits and concerns associated with the vaccine are presented. A current Phase III trial is currently underway using the vaccinia-based prostate-specific antigen vaccine Prostvac-TRICOM. Other immunotherapeutic vaccines in trials include the Ad/prostate-specific antigen vaccine Ad5-prostate-specific antigen and the DNA/prostatic acid phosphatase vaccine. A cellular vaccine, GVAX, has been in clinical trials but has not seen continuous study. This review also delves into the multiple immune regulatory elements that must be overcome in order to obtain strong antitumor-associated antigen immune responses capable of effectively destroying prostate tumor cells.

  3. Trial-to-trial fluctuations in attentional state and their relation to intelligence.

    Science.gov (United States)

    Unsworth, Nash; McMillan, Brittany D

    2014-05-01

    Trial-to-trial fluctuations in attentional state while performing measures of intelligence were examined in the current study. Participants performed various measures of fluid and crystallized intelligence while also providing attentional state ratings prior to each trial. It was found that pre-trial attentional state ratings strongly predicted subsequent trial performance on the fluid intelligence measures, such that when participants rated their current attentional state as highly focused on the current task, performance tended to be high compared to when participants reported their current attentional state as being low and unfocused on the current task. Furthermore, overall attentional state ratings and variability in attentional state ratings were moderately correlated with overall levels of performance on the fluid intelligence measures. However, attentional state ratings did not predict performance on the measure of crystallized intelligence. These results suggest a strong link between variation in attention state and variation in fluid intelligence as postulated by a number of recent theories.

  4. The AIDS Clinical Trials Information Service (ACTIS): a decade of providing clinical trials information.

    Science.gov (United States)

    Katz, Deborah G; Dutcher, Gale A; Toigo, Theresa A; Bates, Ruthann; Temple, Freda; Cadden, Cynthia G

    2002-01-01

    The AIDS Clinical Trials Information Service (ACTIS) is a central resource for information about federally and privately funded HIV/AIDS clinical trials. Sponsored by four components of the U.S. Department of Health and Human Services, ACTIS has been a key part of U.S. HIV/AIDS information and education services since 1989. ACTIS offers a toll-free telephone service, through which trained information specialists can provide callers with information about AIDS clinical trials in English or Spanish, and a website that provides access to clinical trials databases and a variety of educational resources. Future priorities include the development of new resources to target diverse and underserved populations. In addition, research needs to be conducted on the use of telephone services vs. Web-based information exchange to ensure the broadest possible dissemination of up-to-date information on HIV infection and clinical trials.

  5. Patient reported outcomes (PROs in clinical trials: is 'in-trial' guidance lacking? a systematic review.

    Directory of Open Access Journals (Sweden)

    Derek G Kyte

    Full Text Available BACKGROUND: Patient reported outcomes (PROs are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. METHODS AND FINDINGS: Systematic review of 1,362 articles identified 18 eligible papers containing 'in-trial' guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86-0.97, and validity (<2% residual category coding. The majority of guidelines present were concerned with 'pre-trial' activities (72%, for example, outcome measure selection and study design issues, or 'post-trial' activities (16% such as data analysis, reporting and interpretation. 'In-trial' guidelines represented 9.2% of all guidance across the papers reviewed, with content primarily focused on compliance, quality control, proxy assessment and reporting of data collection. There were no guidelines surrounding the management of concerning PRO data. CONCLUSIONS: The findings highlight there are minimal in-trial guidelines in publication regarding PRO data collection and management in clinical trials. No guidance appears to exist for researchers involved with the handling of concerning PRO data. Guidelines are needed, which support researchers to manage all PRO data appropriately and which facilitate unbiased data collection.

  6. Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP panel: clinical trial design

    OpenAIRE

    Lammertse, D; Tuszynski, MH; Steeves, JD; Curt, A; Fawcett, JW; Rask, C; Ditunno, JF; Fehlings, MG; Guest, JD; Ellaway, PH; Kleitman, N; Blight, AR; Dobkin, BH; Grossman, R.; Katoh, H.

    2006-01-01

    The International Campaign for Cures of Spinal Cord Injury Paralysis established a panel tasked with reviewing the methodology for clinical trials for spinal cord injury (SCI), and making recommendations on the conduct of future trials. This is the fourth of four papers. Here, we examine the phases of a clinical trial program, the elements, types, and protocols for valid clinical trial design. The most rigorous and valid SCI clinical trial would be a prospective double-blind randomized contro...

  7. [Radiotherapy phase I trials' methodology: Features].

    Science.gov (United States)

    Rivoirard, R; Vallard, A; Langrand-Escure, J; Guy, J-B; Ben Mrad, M; Yaoxiong, X; Diao, P; Méry, B; Pigne, G; Rancoule, C; Magné, N

    2016-12-01

    In clinical research, biostatistical methods allow the rigorous analysis of data collection and should be defined from the trial design to obtain the appropriate experimental approach. Thus, if the main purpose of phase I is to determine the dose to use during phase II, methodology should be finely adjusted to experimental treatment(s). Today, the methodology for chemotherapy and targeted therapy is well known. For radiotherapy and chemoradiotherapy phase I trials, the primary endpoint must reflect both effectiveness and potential treatment toxicities. Methodology should probably be complex to limit failures in the following phases. However, there are very few data about methodology design in the literature. The present study focuses on these particular trials and their characteristics. It should help to raise existing methodological patterns shortcomings in order to propose new and better-suited designs.

  8. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  9. Control groups in recent septic shock trials

    DEFF Research Database (Denmark)

    Pettilä, Ville; Hjortrup, Peter Buhl; Jakob, Stephan M

    2016-01-01

    , and mortality outcomes, and calculated a data completeness score to provide an overall view of quality of reporting. RESULTS: A total of 24 RCTs were included (mean n = 287 patients and 71 % of eligible patients were randomized). Of the 24 studies, 14 (58 %) presented baseline data on vasopressors and 58......PURPOSE: The interpretation of septic shock trial data is profoundly affected by patients, control intervention, co-interventions and selected outcome measures. We evaluated the reporting of control groups in recent septic shock trials. METHODS: We searched for original articles presenting...... randomized clinical trials (RCTs) in adult septic shock patients from 2006 to 2016. We included RCTs focusing on septic shock patients with at least two parallel groups and at least 50 patients in the control group. We selected and evaluated data items regarding patients, control group characteristics...

  10. WP6 - Application Integration, Trials and Evaluation

    DEFF Research Database (Denmark)

    Prasad, Neeli R.; Cetin, Bilge Kartal; Moran, Humberto;

    2009-01-01

    This deliverable contains all the details on the planning, description of business cases, business goals stakeholders, IT infrastructure, evaluation guidelines and other aspects of the pilot trials, that are envisioned for demonstrating the benefits of the ASPIRE middleware platform. These pilot...... trials mainly consist of controlled and carefully designed experiments that will be organized either by those partners of the consortium who have previous experience on demos or similar events for small and medium enterprises (SMEs), or by other institutions that have accepted to test the ASPIRE...... middleware platform during their trials. The pilots aim to cover different business sectors, scenarios and applications related to RFID (Radio Frequency Identification) systems, thus giving a diverse set of outcomes that will be able to provide a better perspective on how ASPIRE will help in the reduction...

  11. [Ethical implications of clinical trials in Tunisia].

    Science.gov (United States)

    Chadly, Ali

    2004-11-01

    Clinical trials are necessary for medical advancement. They must respect legal obligations. Ethical questions related to protection of the human being's rights are yielded by these trials. Joining research to medical core is problematical in consideration of patient's consent to clinical trial. Exclusion by the Tunisian law of persons under age, pregnant or breast-feeding women from medical experimentation in the aim of protecting them against clinical research adverse events or abuses is ethically questionable since it deprives them from a possible medical progress. So why not to involve them in clinical research when there is an expected benefit, after bringing them protection as vulnerable persons like we should do for instance for the elderly, handicapped persons or prisoners. Legal creation of research ethics committees is important for the respect of experimentation rules on human beings.

  12. Franz Kafka's The Trial: guilty or innocent?

    Science.gov (United States)

    Siegel, E

    1996-07-01

    Through an examination of The Trial by Kafka I attempt to show that the depiction of the Court apparatus is dynamically related to the commission of unconscious crimes of the type we encounter in our patients. To provide a context for the novel, I discuss Kafka's biography and some possible unconscious motivations. My goal is to show how the concept of a particular type of superego pressure can be used to understand the subtle irony in The Trial. Although Joseph K.'s behavior frequently involves oedipal crimes, there are many preoedipal themes that help account for his experience of the Court. I contrast this psychoanalytic understanding of K.'s guilt with that of literary critics who interpret The Trial as an allegory of guilt but who minimize the psychological dimensions.

  13. Perfusion Pressure Cerebral Infarct (PPCI) trial

    DEFF Research Database (Denmark)

    Vedel, Anne G.; Holmgaard, Frederik; Rasmussen, Lars Simon

    2016-01-01

    to be caused by emboli, but inadequate blood flow caused by other mechanisms may increase ischaemia in the penumbra or cause watershed infarcts. During cardiopulmonary bypass, blood pressure can be below the lower limit of cerebral autoregulation. Although much debated, the constant blood flow provided...... by the cardiopulmonary bypass system is still considered by many as appropriate to avoid cerebral ischaemia despite the low blood pressure. Methods/design: The Perfusion Pressure Cerebral Infarct trial is a single-centre superiority trial with a blinded outcome assessment. The trial is randomising 210 patients...... with coronary vessel and/or valve disease and who are undergoing cardiac surgery with the use of cardiopulmonary bypass. Patients are stratified by age and surgical procedure and are randomised 1:1 to either an increased mean arterial pressure (70–80 mmHg) or ‘usual practice’ (40–50 mmHg) during cardiopulmonary...

  14. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  15. Lessons from randomised direct comparative trials.

    Science.gov (United States)

    Achiron, Anat; Fredrikson, Sten

    2009-02-01

    For over a decade, four immunomodulatory therapies have been available for the treatment of relapsing remitting multiple sclerosis. However, few direct comparative data were available to facilitate the choice of treatment. This choice has been influenced by the perception that interferon-beta preparations have greater efficacy than glatiramer acetate, due to apparently more rapid and robust reduction of gadolinium-enhancing lesions seen on magnetic resonance imaging in the pivotal trials of these agents. This situation has changed in the last year, with the outcomes of three randomised clinical trials comparing the efficacy and safety of glatiramer acetate with that of a high-dose interferon-beta in relapsing remitting multiple sclerosis. These are the REGARD, BEYOND and BECOME trials. In the REGARD trial, 764 patients were randomised to treatment with either interferon-beta 1a sc 44 microg or glatiramer acetate for 96 weeks; no significant difference in the time to first relapse was observed. The largest of the three comparative studies, the BEYOND trial, compared treatment with interferon-beta 1b sc 500 microg, interferon-beta 1b sc 250 microg or glatiramer acetate for two years in 2,244 patients. The hazard ratio for multiple relapses was close to unity for comparisons between all groups, indicating equivalent efficacy in all three treatment arms. Relapse rates (around 0.3 relapses/year) in all these studies were much lower than anticipated and lower than those reported a decade previously in the pivotal trials of beta-interferons and glatiramer acetate. No unexpected safety issues were identified in any of these studies. The completion of these direct comparative studies has considerably enriched the clinical evidence database by contributing large numbers of patients. This provides an invaluable contribution for helping the physician make an informed choice about treatment. The results of the direct comparative studies provide evidence that glatiramer acetate

  16. Narrating the Mensalão trial

    DEFF Research Database (Denmark)

    Damgaard, Mads

    2015-01-01

    sentences were meted out to 25 of the 38 defendants, thereby breaking an established pattern of impunity for corrupt politicians in Brazilian courts. As a scandal potentially harmful for the governing party and the former president Luis “Lula” da Silva, the eyes and spotlights of the national media were...... fixed on the trial. However, the varying and contested ways in which the case was presented by media from the outbreak of the scandal in 2005 until the end of the trial bears witness to the fact that narratives concerning corruption scandals can potentially encompass a broad range of political...

  17. Clinical Trials in Male Hormonal Contraception

    Directory of Open Access Journals (Sweden)

    Nieschlag E

    2011-01-01

    Full Text Available Research has established the principle of hormonal male contraception based on suppression of gonadotropins and spermatogenesis. All hormonal male contraceptives use testosterone, but only in East Asian men can testosterone alone suppress spermatogenesis to a level compatible with contraceptive protection. In Caucasians, additional agents are required of which progestins are favored. Clinical trials concentrate on testosterone combined with norethisterone, desogestrel, etonogestrel or depot-medroxyprogesterone acetate. The first randomized, placebo-controlled clinical trial performed by the pharmaceutical industry demonstrated the effectiveness of a combination of testosterone undecanoate and etonogestrel in suppressing spermatogenesis in volunteers.

  18. Clinical Research Methodology 3: Randomized Controlled Trials.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

  19. Photovoltaic domestic field trial. Third annual report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-07-01

    An update on a photovoltaics field trial that has been running for four years is presented. The PV Domestic Field Trial was set up to use the design, construction, performance and monitoring of PV units to generate data for utilities, builders and other current and potential users of PVs. Subjects covered were appearance of the systems, architectural integration, fixing methods, cost effectiveness, opinions of users, monitoring and results. During the past 12 months, most of the human effort has gone into collation of data from 22 of the 28 projects. The study was sponsored by Great Britain's DTI.

  20. Infertility trial outcomes: healthy moms and babies.

    Science.gov (United States)

    Silver, Robert

    2014-05-01

    Traditionally, the primary outcome of infertility trials has been a positive pregnancy test or a clinically recognized pregnancy. However, parents desire a healthy baby that grows up to be a healthy adult, rather than a positive pregnancy test. Too often results of infertility trials are lacking in crucial obstetric details. This is problematic because treatments for infertility have the capacity to increase the risk for a variety of adverse obstetric outcomes. This review will outline important obstetric variables that should be included when reporting infertility research. The rationale for including these data, precise definitions of the variables, and cost-effective strategies for obtaining these obstetric details will be highlighted.

  1. Clinical Trials and their Impact on Society

    Directory of Open Access Journals (Sweden)

    Olga Lidia Cuevas Pérez

    2016-02-01

    Full Text Available Today there are countless examples that illustrate the nature of technoscience, including biotechnology and pharmacology. The clinical trial is the appropriate methodology used by clinical pharmacology to test the efficacy and safety of a treatment or intervention in humans. It constitutes the cornerstone of research. Once the preclinical research is completed, one of the biggest challenges currently facing the Cuban Pharmaceutical and Biotechnological Industry is precisely the clinical evaluation. Therefore, this work aims to provide a reflection on the most significant aspects of clinical trials and their impact on society.

  2. Prospective Clinical Trial for Septic Arthritis

    DEFF Research Database (Denmark)

    Schmal, Hagen; Bernstein, Anke; Feucht, Matthias J;

    2016-01-01

    clinical trial and the cytokine composition of effusions (n = 76) was analyzed. Characteristics of epidemiology and disease severity were correlated with levels of cytokines with known roles in cartilage turnover and degradation. Results. Higher synovial IL-1β concentrations were associated with clinical......-2, and BMP-7. Infections with Staphylococcus species induced higher IL-1β expression but less cartilage destruction than other bacteria. Conclusion. Articular infections have bacteria-specific implications on cartilage metabolism. Collagen type II cleavage products reliably mark destruction, which...... is associated with upregulation of typical cartilage turnover cytokines. This trial is registered with DRKS00003536, MISSinG....

  3. Registration of clinical trials: Is it really needed?

    Directory of Open Access Journals (Sweden)

    Ameer Aslam

    2013-01-01

    Full Text Available Background and Aims: Withholding findings of clinical trials for publication or presentation to the regulatory authorities is a major concern. We aimed to address the importance of clinical trial registration and whether it is needed or not. Discussion: For ethical conduct of clinical trial, registration is an important but debatable issue due to proprietary interest of the pharmaceutical industry. Over the years, investigating agencies uncovered several instances of misconduct during the clinical trial. The International committee of medical journal editors requires registration of trial methodology, but does not require registration of trial results; however, the U.S. Food and Drug Administration Amendments does require researchers to register results. Conclusion: Prospective registration of clinical trial is mandatory for more transparent research and sustaining the validity of evidence based practice and availability of reliable data. Clinical trials registration has the potential to contribute substantially to improve clinical trial transparency and reducing publication bias and selective reporting.

  4. PREGNANCY WITH PLATELET FUNCTION DISORDER

    Directory of Open Access Journals (Sweden)

    Sheila K

    2014-01-01

    Full Text Available latelets play a vital role in haemostasis . Antenatal patients with platelet function disorders should be managed in tertiary care centres that are well equipped to tackle any obstetric haemorrhage that can ensue during labour and delivery . Primi gravida was admitted for safe confinement . She had been evaluated earlier for complaints of multiple episodes of mucosal bleeding . On evaluation she had nor mal platelet counts and coagulation factor assay was normal . Platelet aggregometry revealed mild disorder of platelet aggregation . She was planned for induction of labour after arranging enough blood and blood products . She got into active labour and was p ut on syntocinon augmentation . She had emergency Caesarean section for foetal distress . Oxytocics were given proactively . Intraoperatively platelet transfusions and tranexamic acid infusion were given . Complete haemostasis was achieved . She had an uneventf ul postoperative period . Patients with functional platelet disorders can be successfully managed with local application of antifibrinolytic agents like tranexamic acid , in case of minor bleeds . Platelet transfusions are very effective in tackling major ble eds , especially during surgeries and for obstetric indications . If a patient has the history of clinically significant bleeding suggestive of platelet dysfunction , appropriate platelet function tests should be obtained so that the risk of bleeding can be adequately assessed and therapy chosen more rationally . . In obstetric practice the response of such patients to platelet transfusions has been excellent

  5. Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials.

    Science.gov (United States)

    Godskesen, T M; Kihlbom, U; Nordin, K; Silén, M; Nygren, P

    2016-05-01

    While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels and former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann-Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of close ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups.

  6. Trial-to-trial reoptimization of motor behavior due to changes in task demands is limited.

    Directory of Open Access Journals (Sweden)

    Orban de Xivry J-J

    Full Text Available Each task requires a specific motor behavior that is tuned to task demands. For instance, writing requires a lot of accuracy while clapping does not. It is known that the brain adjusts the motor behavior to different task demands as predicted by optimal control theory. In this study, the mechanism of this reoptimization process is investigated by varying the accuracy demands of a reaching task. In this task, the width of the reaching target (0.5 or 8 cm was varied either on a trial-to-trial basis (random schedule or in blocks (blocked schedule. On some trials, the hand of the subjects was clamped to a rectilinear trajectory that ended 2 cm on the left or right of the target center. The rejection of this perturbation largely varied with target width in the blocked schedule but not in the random schedule. That is, subjects exhibited different motor behavior in the different schedules despite identical accuracy demands. Therefore, while reoptimization has been considered immediate and automatic, the differences in motor behavior observed across schedules suggest that the reoptimization of the motor behavior is neither happening on a trial-by-trial basis nor obligatory. The absence of trial-to-trial mechanisms, the inability of the brain to adapt to two conflicting task demands and the existence of a switching cost are discussed as possible sources of the non-optimality of motor behavior during the random schedule.

  7. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials for hand osteoarthritis.

    Science.gov (United States)

    Kloppenburg, M; Maheu, E; Kraus, V B; Cicuttini, F; Doherty, M; Dreiser, R-L; Henrotin, Y; Jiang, G-L; Mandl, L; Martel-Pelletier, J; Nelson, A E; Neogi, T; Pelletier, J-P; Punzi, L; Ramonda, R; Simon, L S; Wang, S

    2015-05-01

    Hand osteoarthritis (OA) is a very frequent disease, but yet understudied. However, a lot of works have been published in the past 10 years, and much has been done to better understand its clinical course and structural progression. Despite this new knowledge, few therapeutic trials have been conducted in hand OA. The last OARSI recommendations for the conduct of clinical trials in hand OA dates back to 2006. The present recommendations aimed at updating previous recommendations, by incorporating new data. The purpose of this expert opinion, consensus driven exercise is to provide evidence-based guidance on the design, execution and analysis of clinical trials in hand OA, where published evidence is available, supplemented by expert opinion, where evidence is lacking, to perform clinical trials in hand OA, both for symptom and for structure-modification. They indicate core outcome measurement sets for studies in hand OA, and list the methods and instruments that should be used to measure symptoms or structure. For both symptom- and structure-modification, at least pain, physical function, patient global assessment, HR-QoL, joint activity and hand strength should be assessed. In addition, for structure-modification trials, structural progression should be measured by radiographic changes. We also provide a research agenda listing many unsolved issues that seem to most urgently need to be addressed from the perspective of performing "good" clinical trials in hand OA. These updated OARSI recommendations should allow for better standardizing the conduct of clinical trials in hand OA in the next future.

  8. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry

    Science.gov (United States)

    Desselas, Emilie; Pansieri, Claudia; Leroux, Stephanie; Bonati, Maurizio; Jacqz-Aigrain, Evelyne

    2017-01-01

    Background Despite specific initiatives and identified needs, most neonatal drugs are still used off-label, with variable dosage administrations and schedules. In high risk preterm and term neonates, drug evaluation is challenging and randomized controlled trials (RCT) are difficult to conduct and even more is the use of a placebo, required in the absence of a reference validated drug to be used as comparator. Methods We analyzed the complete ClinicalTrials.gov registry 1) to describe neonatal RCT involving a placebo, 2) to report on the medical context and ethical aspects of placebo use. Results Placebo versus drug RCT (n = 146), either prevention trials (n = 57, 39%) or therapeutic interventions (n = 89, 61%), represent more than a third of neonatal trials registered in the National Institute of Health clinical trial database (USA) since 1999. They mainly concerned preterm infants, evaluating complications of prematurity. Most trials were conducted in the USA, were single centered, and funded by non-profit organizations. For the three top drug trials evaluating steroids (n = 13, 9.6%), erythropoietin (EPO, n = 10, 6.8%) and nitric oxide (NO, n = 9, 6.2%), the objectives of the trial and follow-up were analyzed in more details. Conclusion Although a matter of debate, the use of placebo should be promoted in neonates to evaluate a potential new treatment, in the absence of reference drug. Analysis of the trials evaluating steroids showed that long-term follow-up of exposed patients, although required by international guidelines, is frequently missing and should be planned to collect additional information and optimize drug evaluation in these high-risk patients. PMID:28192509

  9. Patient representatives' views on patient information in clinical cancer trials

    DEFF Research Database (Denmark)

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

    consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. METHODS: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I......-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. RESULTS: Two major themes emerged: emotional responses and cognitive...

  10. Acute Heart Failure | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available r investigation E.1.1Medical condition(s) being investigated Acute Heart Failure MedDRA Classification E.1.3...in one hour of admission to ICU.3. Signed informed consent E.4Principal exclusion criteria 1. Age less than 18 years.2. Acute...y with Trimetazidine in Acute heart failure: an open pilot randomized trial (The METTA – PRAGUE 10 Trial) A....e ConcernedCzech Republic - SUKL A.2EudraCT number2007-002893-76 A.3Full title of the trial MEtabolic Therap

  11. Inherited Retinal Degenerative Clinical Trial Network

    Science.gov (United States)

    2009-10-01

    created military Vision Center of Excellence in NEER steering committee meetings and deliberations. References: 1. Cideciyan AV, Aleman TS, Boye SL, et...2008;105:15112-15117. 2. Hauswirth W, Aleman TS, Kaushal S, et al. Phase I Trial of Leber Congenital Amaurosis due to RPE65 Mutations by Ocular

  12. Stroke Prevention Trials in Sickle Cell Anemia

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2006-06-01

    Full Text Available As part of an International Pediatric Stroke Study launched in 2002, the Stroke Prevention Trial in Sickle Cell Anemia (STOP reports a reduction in the number of overt clinical strokes in children with critically high transcranial Doppler velocities (>200 cm/sec who were regularly transfused.

  13. TBCS/Chameleon Utility Trial Report

    Science.gov (United States)

    2005-05-01

    mission contexts, different mission tasks, different time pressures and different team roles . For example, the levels of detail to support planning before...predictive value of the results. • the low level of experience in the personnel who played combat team roles in the trial • a single participant at each

  14. Lung Cancer Clinical Trials: Advances in Immunotherapy

    Science.gov (United States)

    New treatments for lung cancer and aspects of joining a clinical trial are discussed in this 30-minute Facebook Live event, hosted by NCI’s Dr. Shakun Malik, head of thoracic oncology therapeutics, and Janet Freeman-Daily, lung cancer patient activist and founding member of #LCSM.

  15. Unit: Cells, Inspection Set, National Trial Print.

    Science.gov (United States)

    Australian Science Education Project, Toorak, Victoria.

    This trial version of a unit is the series being produced by the Australian Science Education Project provides instructions for students to prepare a variety of cell types and examine them with microscopes. It also gives some information about the variety and function of cells. The core of the unit, which all students are expected to complete,…

  16. Single-Trial Inference on Visual Attention

    DEFF Research Database (Denmark)

    Dyrholm, Mads; Kyllingsbæk, Søren; Vangkilde, Signe Allerup

    2011-01-01

    In this paper we take a step towards single-trial behavioral modeling within a Theory of Visual Attention (TVA). In selective attention tasks, such as the Partial Report paradigm, the subject is asked to ignore distractors and only report stimuli that belong to the target class. Nothing about...

  17. International criminal trials: A normative theory

    NARCIS (Netherlands)

    Vasiliev, S.

    2014-01-01

    Among the numerous works on international criminal procedure, there has been no study focusing on the international criminal trial as a socio-legal phenomenon and a phase of international criminal proceedings. This book seeks to cover this gap by systematically examining and analyzing the nature and

  18. The Nuremberg Trials: Considerations and Suggestions

    Science.gov (United States)

    Thorpe, Gerald L.

    1971-01-01

    The purpose of this article is: (1) to identify the problem of first importance raised by the trials: individual moral decisions in juxtaposition to the will of that individual's government; (2) to provide some guidelines for teaching; and (3) to outline broad procedures for effecting those guidelines. (Author/JB)

  19. Unit: Plants, Inspection Pack, National Trial Print.

    Science.gov (United States)

    Australian Science Education Project, Toorak, Victoria.

    This is a National Trial Print of a unit on plants produced as a part of the Australian Science Education Project. The unit consists of an information booklet for students, a booklet for recording student data, and a teacher's guide. The material, designed for use with students in the upper elementary grades, takes from 15 to 20 forty-minute…

  20. Placebo-Controlled Trials, Ethics of

    NARCIS (Netherlands)

    van der Graaf, R; Rid, Annette

    2015-01-01

    There are often good scientific and ethical reasons for using placebo controls in clinical trials. At the same time placebo use is controversial, especially when an established effective treatment is being withheld from the control group. This article gives an overview of the key ethical positions i

  1. Trial access to Cambridge University Press ebooks

    CERN Multimedia

    CERN Library

    2011-01-01

    From 1 August till 31 October, CERN users are invited to enjoy a trial access to all Cambridge University Press electronic books: http://ebooks.cambridge.org/. Please don't hesitate to send feedback to library.desk@cern.ch.

  2. Novel ocular antihypertensive compounds in clinical trials

    Directory of Open Access Journals (Sweden)

    Chen J

    2011-05-01

    Full Text Available June Chen1, Stephen A Runyan1, Michael R Robinson21Department of Biological Sciences, 2Ophthalmology Clinical Research, Allergan, Inc, Irvine, CA, USAIntroduction: Glaucoma is a multifactorial disease characterized by progressive optic nerve injury and visual field defects. Elevated intraocular pressure (IOP is the most widely recognized risk factor for the onset and progression of open-angle glaucoma, and IOP-lowering medications comprise the primary treatment strategy. IOP elevation in glaucoma is associated with diminished or obstructed aqueous humor outflow. Pharmacotherapy reduces IOP by suppressing aqueous inflow and/or increasing aqueous outflow.Purpose: This review focuses on novel non-FDA approved ocular antihypertensive compounds being investigated for IOP reduction in ocular hypertensive and glaucoma patients in active clinical trials within approximately the past 2 years.Methods: The mode of IOP reduction, pharmacology, efficacy, and safety of these new agents were assessed. Relevant drug efficacy and safety trials were identified from searches of various scientific literature databases and clinical trial registries. Compounds with no specified drug class, insufficient background information, reformulations, and fixed-combinations of marketed drugs were not considered.Results: The investigational agents identified comprise those that act on the same targets of established drug classes approved by the FDA (ie, prostaglandin analogs and β-adrenergic blockers as well as agents belonging to novel drug classes with unique mechanisms of action. Novel targets and compounds evaluated in clinical trials include an actin polymerization inhibitor (ie, latrunculin, Rho-associated protein kinase inhibitors, adenosine receptor analogs, an angiotensin II type 1 receptor antagonist, cannabinoid receptor agonists, and a serotonin receptor antagonist.Conclusion: The clinical value of novel compounds for the treatment of glaucoma will depend

  3. ADEPT - Abnormal Doppler Enteral Prescription Trial

    Directory of Open Access Journals (Sweden)

    McCormick Kenny

    2009-10-01

    Full Text Available Abstract Background Pregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted. These babies are at high risk of milk intolerance and necrotising enterocolitis, as well as post-natal growth failure, and there is no clinical consensus about how best to feed them. Policies of both early milk feeding and late milk feeding are widely used. This randomised controlled trial aims to determine whether a policy of early initiation of milk feeds is beneficial compared with late initiation. Optimising neonatal feeding for this group of babies may have long-term health implications and if either of these policies is shown to be beneficial it can be immediately adopted into clinical practice. Methods and Design Babies with gestational age below 35 weeks, and with birth weight below 10th centile for gestational age, will be randomly allocated to an "early" or "late" enteral feeding regimen, commencing milk feeds on day 2 and day 6 after birth, respectively. Feeds will be gradually increased over 9-13 days (depending on gestational age using a schedule derived from those used in hospitals in the Eastern and South Western Regions of England, based on surveys of feeding practice. Primary outcome measures are time to establish full enteral feeding and necrotising enterocolitis; secondary outcomes include sepsis and growth. The target sample size is 400 babies. This sample size is large enough to detect a clinically meaningful difference of 3 days in time to establish full enteral feeds between the two feeding policies, with 90% power and a 5% 2-sided significance level. Initial recruitment period was 24 months, subsequently extended to 38 months. Discussion There is limited evidence from randomised controlled trials on which to base decisions regarding feeding policy in high risk preterm infants. This multicentre trial will help to guide clinical practice and may also

  4. Establishing a clinical trials network in nephrology: experience of the Australasian Kidney Trials Network.

    Science.gov (United States)

    Morrish, Alicia T; Hawley, Carmel M; Johnson, David W; Badve, Sunil V; Perkovic, Vlado; Reidlinger, Donna M; Cass, Alan

    2014-01-01

    Chronic kidney disease is a major public health problem globally. Despite this, there are fewer high-quality, high-impact clinical trials in nephrology than other internal medicine specialties, which has led to large gaps in evidence. To address this deficiency, the Australasian Kidney Trials Network, a Collaborative Research Group, was formed in 2005. Since then, the Network has provided infrastructure and expertise to conduct patient-focused high-quality, investigator-initiated clinical trials in nephrology. The Network has not only been successful in engaging the nephrology community in Australia and New Zealand but also in forming collaborations with leading researchers from other countries. This article describes the establishment, development, and functions of the Network. The article also discusses the current and future funding strategies to ensure uninterrupted conduct of much needed clinical trials in nephrology to improve the outcomes of patients affected by kidney diseases with cost-effective interventions.

  5. Ph+ CML in early chronic phase | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available the trial The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia... protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia (CML) i

  6. Acute sore throat | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute... sore throat E.1.1.1Medical condition in easily understood language Acute sore

  7. Acute lymphoblastic leukemia | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available on the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute... lymphoblastic leukemia E.1.1.1Medical condition in easily understood language Acute lymphoblastic

  8. Acute Ischemic Stroke | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available State ConcernedFinland - Fimea A.2EudraCT number2011-003474-86 A.3Full title of the trial Albumin in Acute ...erapy for Neuroprotection in Acute Ischemic Stroke A.3.1Title of the trial for la...y people, in easily understood, i.e. non-technical, language Albumin in Acute Stroke (ALIAS) Trial-Part 2 A....se under investigation E.1.1Medical condition(s) being investigated Acute Ischemic Stroke E.1.1.2Therapeutic...n, - cognition measured at 3 months by Trailmaking A and B. E.2.3Trial contains a sub-study No E.3Principal inclusion criteria - Acut

  9. Acute Lower Limb Ischemia | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available 77-40 A.3Full title of the trial Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized Do... and Efficacy Of MST-188 in Subjects with Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant ...3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language Evaluation of MST-188 in Acute...an A.3.2Name or abbreviated title of the trial where available Evaluation of MST-188 in Acute Lower Limb Isc...neral Information on the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acut

  10. Obsessive Compulsive Disorder | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available pulsions to assess OCD severity) both within and between the three treatment arms w... of the trial Outcome measures will be evaluated. The variation in the Y-BOCS (a specific questionnaire looking at obsessions and com

  11. The RESOLVE Trial for people with chronic low back pain: protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Matthew K Bagg

    2017-01-01

    Full Text Available Introduction: Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials

  12. Can we identify non-stationary dynamics of trial-to-trial variability?

    Directory of Open Access Journals (Sweden)

    Emili Balaguer-Ballester

    Full Text Available Identifying sources of the apparent variability in non-stationary scenarios is a fundamental problem in many biological data analysis settings. For instance, neurophysiological responses to the same task often vary from each repetition of the same experiment (trial to the next. The origin and functional role of this observed variability is one of the fundamental questions in neuroscience. The nature of such trial-to-trial dynamics however remains largely elusive to current data analysis approaches. A range of strategies have been proposed in modalities such as electro-encephalography but gaining a fundamental insight into latent sources of trial-to-trial variability in neural recordings is still a major challenge. In this paper, we present a proof-of-concept study to the analysis of trial-to-trial variability dynamics founded on non-autonomous dynamical systems. At this initial stage, we evaluate the capacity of a simple statistic based on the behaviour of trajectories in classification settings, the trajectory coherence, in order to identify trial-to-trial dynamics. First, we derive the conditions leading to observable changes in datasets generated by a compact dynamical system (the Duffing equation. This canonical system plays the role of a ubiquitous model of non-stationary supervised classification problems. Second, we estimate the coherence of class-trajectories in empirically reconstructed space of system states. We show how this analysis can discern variations attributable to non-autonomous deterministic processes from stochastic fluctuations. The analyses are benchmarked using simulated and two different real datasets which have been shown to exhibit attractor dynamics. As an illustrative example, we focused on the analysis of the rat's frontal cortex ensemble dynamics during a decision-making task. Results suggest that, in line with recent hypotheses, rather than internal noise, it is the deterministic trend which most likely underlies

  13. The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

    OpenAIRE

    Forster Anne; Young John; Barber Sally; Clegg Andrew; Iliffe Steve

    2011-01-01

    Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE) trial is a two arm, assessor blind pilot randomised controlled trial (RCT) to a...

  14. Acute Myocardial Infarction | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available of the trial Inhibition of δ-PROTEin kinase C for the reducTION of infarct size in Acute Myocardial Infarcti... the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...ease under investigation E.1.2Version 9.1 E.1.2Level LLT E.1.2Classification code 10000891 E.1.2Term Acute m

  15. Acute Alcoholic Hepatitis | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available UK - MHRA A.2EudraCT number2006-004419-24 A.3Full title of the trial The Use of Sulfasalazine as an Anti-fibrotic in Acute...General Information on the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition...(s) being investigated Acute Alcoholic Hepatitis MedDRA Classification E.1.2 Medical condition or disease un

  16. Clinical trials in Ayurveda: Analysis of clinical trial registry of India.

    Science.gov (United States)

    Sridharan, Kannan; Sivaramakrishnan, Gowri

    Ayurveda is one of the complementary and alternative systems of medicine requiring generation of high quality evidence for rational practice. Evidence can be generated from study designs and the present study is an attempt to critically assess the registered studies in the field of Ayurveda from clinical trial registry of India. We found low number of trials conducted with more focus required on the quality of these studies to contribute to high quality evidence.

  17. Genital Herpes Vaccine Shows Promise in Animal Trials

    Science.gov (United States)

    ... 163137.html Genital Herpes Vaccine Shows Promise in Animal Trials Two-pronged approach tested on lab monkeys, guinea ... vaccines have not shown very robust protection in animal and human trials. Friedman and his colleagues decided that an effective ...

  18. FDA Encourages More Participation, Diversity in Clinical Trials

    Science.gov (United States)

    ... Consumer Updates FDA Encourages More Participation, Diversity in Clinical Trials Share Tweet Linkedin Pin it More sharing options ... while research is conducted. back to top Do clinical trials have possible risks and benefits? Yes. Sometimes patients ...

  19. 32 CFR 9.6 - Conduct of the trial.

    Science.gov (United States)

    2010-07-01

    ... the oath is administered and that binds that person to speak the truth, or, in the case of one other... property to the United States for disposition. (h) Post-trial procedures—(1) Record of Trial....

  20. Ambulatory Pessary Trial Unmasks Occult Stress Urinary Incontinence

    Directory of Open Access Journals (Sweden)

    Bilal Chughtai

    2012-01-01

    Conclusion. An ambulatory pessary trial is an effective, easy, and inexpensive method to approximate anatomic results achieved by surgery under real-life conditions. In our series, 20% of patients with occult SUI were identified by pessary trial alone.

  1. Use of crowdsourcing for cancer clinical trial development.

    Science.gov (United States)

    Leiter, Amanda; Sablinski, Tomasz; Diefenbach, Michael; Foster, Marc; Greenberg, Alex; Holland, John; Oh, William K; Galsky, Matthew D

    2014-10-01

    Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct.

  2. Trial-by-trial switching between procedural and declarative categorization systems.

    Science.gov (United States)

    Crossley, Matthew J; Roeder, Jessica L; Helie, Sebastien; Ashby, F Gregory

    2016-11-30

    Considerable evidence suggests that human category learning recruits multiple memory systems. A popular assumption is that procedural memory is used to form stimulus-to-response mappings, whereas declarative memory is used to form and test explicit rules about category membership. The multiple systems framework has been successful in motivating and accounting for a broad array of empirical observations over the past 20 years. Even so, only a couple of studies have examined how the different categorization systems interact. Both previous studies suggest that switching between explicit and procedural responding is extremely difficult. But they leave unanswered the critical questions of whether trial-by-trial system switching is possible, and if so, whether it is qualitatively different than trial-by-trial switching between two explicit tasks. The experiment described in this article addressed these questions. The results (1) confirm that effective trial-by-trial system switching, although difficult, is possible; (2) suggest that switching between tasks mediated by different memory systems is more difficult than switching between two declarative memory tasks; and (3) point to a serious shortcoming of current category-learning theories.

  3. Single-trial normalization for event-related spectral decomposition reduces sensitivity to noisy trials

    Directory of Open Access Journals (Sweden)

    Romain eGrandchamp

    2011-09-01

    Full Text Available In EEG research, the classical Event-Related Potential (ERP model often proves to be a limited method when studying complex brain dynamics. For this reason, spectral techniques adapted from signal processing such as Event-Related Spectral Perturbation (ERSP – and its variant ERS (Event-Related Synchronization and ERD (Event-Related Desynchronization – have been used over the past 20-years. They represent average spectral changes in response to a stimulus.These spectral methods do not have strong consensus for comparing pre and post-stimulus activity. When computing ERSP, pre-stimulus baseline removal is usually performed after averaging the spectral estimate of multiple trials. Correcting the baseline of each single-trial prior to averaging spectral estimates is an alternative baseline correction method. However, we show that this method leads to positively skewed post-stimulus ERSP values. We eventually present new single-trial based ERSP baseline correction methods that perform trial normalization or centering prior to applying classical baseline correction methods. We show that single-trial correction methods minimize the contribution of artifactual data trials with high-amplitude spectral estimates and are robust to outliers when performing statistical inference testing. We then characterize these methods in terms of their time-frequency responses and behavior when performing statistical inference testing compared to classical ERSP methods.

  4. Challenges and lessons learned in conducting comparative-effectiveness trials.

    Science.gov (United States)

    Herrick, Linda M; Locke, G Richard; Zinsmeister, Alan R; Talley, Nicholas J

    2012-05-01

    The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.

  5. What is the impact of ethics on clinical trials?

    Science.gov (United States)

    Spielman, Bethany

    2016-01-01

    Ethics has often been ignored or evaded in clinical trials, and the conditions under which global clinical trials are conducted make this problem likely to persist. Ethics can, however, have an impact at any of several stages of a trial when the individuals involved are committed. This editorial provides historical examples of ignoring, evading or, alternatively, using ethical help to improve clinical trials, and suggests that the actual role of ethics depends on the individuals involved.

  6. Differences Between Clinical Trials of Medical Devices and Drugs

    Institute of Scientific and Technical Information of China (English)

    ZHANG Zhi-jun; LIU Wei

    2014-01-01

    How to design clinical trials for medical devices is a problem plaguing the industry today. As there are many differences in clinical trials of medical devices and drugs. This paper describes the differences of the two points from the perspectivs of defi-nition of medical devices and drugs, scope, phasing, subjects and design of clinical trials in details, aiming to help the related personnel make scientific decisions while conduct-ing clinical trial design for medical devices.

  7. Analysis of regulatory-ethical framework of clinical trials

    OpenAIRE

    Milošević-Georgiev Andrijana; Krajnović Dušanka; Milovanović Srđan; Ignjatović Svetlana; Đurić Dušan; Marinković Valentina

    2013-01-01

    Introduction. Every clinical trial has to meet all ethical criteria in addition to the scientific ones. The basic ethical principles in the clinical trials are the following: nonmaleficence, beneficence, respect for autonomy and the principle of justice. Objective. The aim of the study was to analyze clinical cases with the outcomes leading to the changes in regulatory­ethical framework related to the clinical trials, as well as the outcomes of key clinical trials that influenced the in...

  8. Continental cement trial burn strategy follow-up

    Energy Technology Data Exchange (ETDEWEB)

    Woodford, J. [Gossman Consulting, Inc., Springboro, OH (United States); Winders, H. [Continental Cement Company, Hannibal, MO (United States); Constans, D.L. [Gossman Consulting, Inc., Peachtree City, GA (United States)

    1997-12-31

    The Continental Trial Burn strategy, presented at the 1995 BIF Conference, included the use of {open_quotes}data-in-lieu-of{close_quotes} from previous compliance testing conducted at the facility. Since the submission of the Trial Burn Plan and the 1995 presentation, Continental Cement has completed their two campaign trial burn. This paper will update the implementation of the Continental Trial Burn strategy. 1 fig., 1 tab.

  9. Randomization in substance abuse clinical trials

    Directory of Open Access Journals (Sweden)

    Woolson Robert F

    2006-02-01

    Full Text Available Abstract Background A well designed randomized clinical trial rates as the highest level of evidence for a particular intervention's efficacy. Randomization, a fundamental feature of clinical trials design, is a process invoking the use of probability to assign treatment interventions to patients. In general, randomization techniques pursue the goal of providing objectivity to the assignment of treatments, while at the same time balancing for treatment assignment totals and covariate distributions. Numerous randomization techniques, each with varying properties of randomness and balance, are suggested in the statistical literature. This paper reviews common randomization techniques often used in substance abuse research and an application from a National Institute on Drug Abuse (NIDA-funded clinical trial in substance abuse is used to illustrate several choices an investigator faces when designing a clinical trial. Results Comparisons and contrasts of randomization schemes are provided with respect to deterministic and balancing properties. Specifically, Monte Carlo simulation is used to explore the balancing nature of randomization techniques for moderately sized clinical trials. Results demonstrate large treatment imbalance for complete randomization with less imbalance for the urn or adaptive scheme. The urn and adaptive randomization methods display smaller treatment imbalance as demonstrated by the low variability of treatment allocation imbalance. For all randomization schemes, covariate imbalance between treatment arms was small with little variation between adaptive schemes, stratified schemes and unstratified schemes given that sample sizes were moderate to large. Conclusion We develop this paper with the goal of reminding substance abuse researchers of the broad array of randomization options available for clinical trial designs. There may be too quick a tendency for substance abuse researchers to implement the fashionable urn

  10. Sample size calculations for 3-level cluster randomized trials

    NARCIS (Netherlands)

    Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.

    2008-01-01

    BACKGROUND: The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health ca

  11. Sample size calculations for 3-level cluster randomized trials

    NARCIS (Netherlands)

    Teerenstra, S.; Moerbeek, M.; Achterberg, T. van; Pelzer, B.J.; Borm, G.F.

    2008-01-01

    Background The first applications of cluster randomized trials with three instead of two levels are beginning to appear in health research, for instance, in trials where different strategies to implement best-practice guidelines are compared. In such trials, the strategy is implemented in health car

  12. On the methodology of drug trials in migraine with aura

    DEFF Research Database (Denmark)

    Hauge, Anne Werner; Hougaard, Anders; Olesen, Jes

    2010-01-01

    INTRODUCTION: Specific problems occur in clinical treatment trials for migraine with aura that differ from those encountered in treatment trials for migraine without aura. DISCUSSION: Based on our experience with four such trials, we point to a number of possible solutions and outline areas...

  13. An interim analysis of recruitment to the COLOFOL trial

    DEFF Research Database (Denmark)

    Wille-Jørgensen, Peer; Laurberg, S.; Pahlman, L.

    2009-01-01

    Objective To analyse the ongoing process of recruiting patients into a multicenter randomized trial on follow-up after curative surgery for colorectal cancer. The trial is registered in Clinical Trials Registration. Method Prospective registration of all operated patients as well as inclusions (c...

  14. Classroom Application of a Trial-Based Functional Analysis

    Science.gov (United States)

    Bloom, Sarah E.; Iwata, Brian A.; Fritz, Jennifer N.; Roscoe, Eileen M.; Carreau, Abbey B.

    2011-01-01

    We evaluated a trial-based approach to conducting functional analyses in classroom settings. Ten students referred for problem behavior were exposed to a series of assessment trials, which were interspersed among classroom activities throughout the day. Results of these trial-based functional analyses were compared to those of more traditional…

  15. The challenge of retaining customers acquired with free trials

    NARCIS (Netherlands)

    Datta, H.; Foubert, B.; van Heerde, H.J.

    2015-01-01

    Many service firms acquire customers by offering free-trial promotions. A crucial challenge is to retain customers acquired with these free trials. To address this challenge, firms need to understand how free-trial customers differ from regular customers in terms of their decision making to retain t

  16. To fail or not to fail : clinical trials in depression

    NARCIS (Netherlands)

    Santen, Gijs Willem Eduard

    2008-01-01

    To fail or not to fail – Clinical trials in depression investigates the causes of the high failure rate of clinical trials in depression research. Apart from the difficulties in the search for new antidepressants during drug discovery, faulty clinical trial designs hinder their evaluation during dru

  17. Clinical trials in allied medical fields: A cross-sectional analysis of World Health Organization International Clinical Trial Registry Platform

    Directory of Open Access Journals (Sweden)

    S. Kannan

    2016-03-01

    Conclusion: The number of clinical trials done in allied fields of medicine other than the allopathic system has lowered down, and furthermore focus is required regarding the methodological quality of these trials and more support from various organizations.

  18. Efficacy and effectiveness as aspects of cluster randomized trials with nursing home residents: Methodological insights from a pneumonia prevention trial

    OpenAIRE

    Van Ness, Peter H.; Peduzzi, Peter N.; Quagliarello, Vincent J.

    2012-01-01

    This report discusses how methodological aspects of study efficacy and effectiveness combine in cluster randomized trials in nursing homes. Discussion focuses on the relationships between these study aspects in the Pneumonia Reduction in Institutionalized Disabled Elders (PRIDE) trial, an ongoing cluster randomized clinical trial of pneumonia prevention among nursing home residents launched in October 2009 in Greater New Haven, Connecticut. This clinical trial has enrolled long-term care nurs...

  19. On the Complexity of Trial and Error

    CERN Document Server

    Bei, Xiaohui; Zhang, Shengyu

    2012-01-01

    Motivated by certain applications from physics, biochemistry, economics, and computer science, in which the objects under investigation are not accessible because of various limitations, we propose a trial-and-error model to examine algorithmic issues in such situations. Given a search problem with a hidden input, we are asked to find a valid solution, to find which we can propose candidate solutions (trials), and use observed violations (errors), to prepare future proposals. In accordance with our motivating applications, we consider the fairly broad class of constraint satisfaction problems, and assume that errors are signaled by a verification oracle in the format of the index of a violated constraint (with the content of the constraint still hidden). Our discoveries are summarized as follows. On one hand, despite the seemingly very little information provided by the verification oracle, efficient algorithms do exist for a number of important problems. For the Nash, Core, Stable Matching, and SAT problems,...

  20. Malaria vaccines: lessons from field trials

    Directory of Open Access Journals (Sweden)

    Claudio J. Struchiner

    1994-07-01

    Full Text Available Malaria vaccine candidates have already been tested and new trials are being carried out. We present a brief description of specific issues of validity that are relevant when assessing vaccine efficacy in the field and illustrate how the application of these principles might improve our interpretation of the data being gathered in actual malaria vaccine field trials. Our discussion assumes that vaccine evaluation shares the same general principles of validity with epidemiologic causal inference, i.e., the process of drawing inferences from epidemiologic data aiming at the identification of causes of diseases. Judicious exercise of these principles indicates that, for meaningful interpretation, measures of vaccine efficacy require definitions based upon arguments conditional on the amount of exposure to infection, and specification of the initial and final states in which one believes the effect of interest takes place.

  1. Clobazam: uncontrolled and standard controlled clinical trials.

    Science.gov (United States)

    Ban, T A; Amin, M M

    1979-01-01

    1 In an uncontrolled clinical trial, carried out in 11 psychiatric patients with the clinical diagnoses of anxiety neurosis and depressive neurosis, clobazam, a new benzodiazepine preparation, in the dosage range 10-60 mg daily produced statistically significant improvement in the total and both factor scores of the Hamilton Anxiety Scale (HAM-A). The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 48 mg daily. 2 Results of the uncontrolled clinical trial were further substantiated in a standard-controlled clinical study in which no statistically significant difference between the therapeutic effectiveness of clobazam and diazepam could be revealed. The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 49 mg daily. There was a lower incidence of adverse effects reported in patients receiving clobazam than in those taking the control drug (diazepam).

  2. THE RIGHT TO A FAIR TRIAL

    Directory of Open Access Journals (Sweden)

    FLORICA BRASOVEANU

    2012-05-01

    Full Text Available Among the general rights of the citizen on finds the free access to justice, the rights to defense and the right to legal security. The jurisprudence based on principles of law and on international treaties, caused the appearance, along the constitutional protection provided by default by a lawyer, of the need of fair and equitable procedures to ensure a balance in the rights of the parties. Today the right to a fair trial is a fundamental right most frequently invoked in front of Romanian courts, as in complaints to the European Court of Human Rights. This study is intended as a guide of the most important solutions that have been promoted to ensure the protection of the right to a fair trial with all the guarantees that are involved, starting with the right of access to justice and ending with the right to adversarial proceedings.

  3. Gone fishing in a fluid trial

    DEFF Research Database (Denmark)

    Hjortrup, Peter B; Haase, Nicolai; Wetterslev, Jørn

    2016-01-01

    OBJECTIVE: To maximise the yield of existing data by assessing the effect on mortality of being born under the zodiac sign Pisces in a trial of intravenous (IV) fluids. DESIGN, SETTING AND PARTICIPANTS: A retrospective observational study, with no predefined hypothesis or statistical analysis plan...... randomised patients in our study; 70 (9%) were born under the sign of Pisces. The primary outcome (death within 90 days after randomisation) occurred in 25 patients (35.7%) in the Pisces group, compared with 348 patients (48%) in the non-Pisces group (relative risk, 0.75; 95% CI, 0.54-1.03; one-sided P = 0.......03). CONCLUSIONS: In a multicentre randomised clinical trial of IV fluids, being born under the sign of Pisces was associated with a decreased risk of death. Our study shows that with convenient use of statistics and an enticing explanatory hypothesis, it is possible to achieve significant findings in post...

  4. [Clinical trials with advanced therapy medicinal products].

    Science.gov (United States)

    Schüssler-Lenz, M; Schneider, C K

    2010-01-01

    For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as medicinal products or medical devices. Thus, for some products no data from clinical studies are available, e.g., for autologous chondrocyte products. The draft guideline on Good Clinical Practice for clinical trials with advanced therapies describes specific additional requirements, e.g., ensuring traceability. Most clinical studies with advanced therapies in Germany are still in early phase I or II trials with highly divergent types of products and clinical indications. The Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMEA) has been established to meet the scientific and regulatory challenges with advanced therapies.

  5. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  6. How do researchers decide early clinical trials?

    Science.gov (United States)

    Grankvist, Hannah; Kimmelman, Jonathan

    2016-06-01

    Launch of clinical investigation represents a substantial escalation in commitment to a particular clinical translation trajectory; it also exposes human subjects to poorly understood interventions. Despite these high stakes, there is little to guide decision-makers on the scientific and ethical evaluation of early phase trials. In this article, we review policies and consensus statements on human protections, drug regulation, and research design surrounding trial launch, and conclude that decision-making is largely left to the discretion of research teams and sponsors. We then review what is currently understood about how research teams exercise this discretion, and close by laying out a research agenda for characterizing the way investigators, sponsors, and reviewers approach decision-making in early phase research.

  7. Development of immunization trials against Pasteurella multocida.

    Science.gov (United States)

    Ahmad, Tarek A; Rammah, Samar S; Sheweita, Salah A; Haroun, Medhat; El-Sayed, Laila H

    2014-02-12

    Pasteurellosis is one of the most important respiratory diseases facing economically valuable farm animals such as poultry, rabbit, cattle, goats and pigs. It causes severe economic loss due to its symptoms that range from primary local infection to fatal septicemia. Pasteurella multocida is the responsible pathogen for this contagious disease. Chemotherapeutic treatment of Pasteurella is expensive, lengthy, and ineffective due to the increasing antibiotics resistance of the bacterium, as well as its toxicity to human consumers. Though, biosecurity measures played a role in diminishing the spread of the pathogen, the immunization methods were always the most potent preventive measures. Since the early 1950s, several trials for constructing and formulating effective vaccines were followed. This up-to-date review classifies and documents such trials. A section is devoted to discussing each group benefits and defects.

  8. Trials registration: a new era in Thailand.

    Science.gov (United States)

    Kulvichit, Kittisak; Tulvatana, Wasee; Thinkhamrop, Bandit; Tatsanavivat, Pyatat

    2013-10-01

    Registration of clinical trials or research can result in many benefits. Patients have access to pertinent information. We have a better and more indicative picture of research status in areas where registration is mandatory. Researchers can use the information to form a common interest group and collaborate their research as well as to avoid unnecessary duplication. Registered information can also enable detection of defective design and can lead to improvements of trial protocol or its implementation. Most importantly, it can help to reduce problems of publication bias and selective reporting. Journals do not like to publish negative or inconclusive results. Pharmaceutical companies are reluctant to report results that may jeopardize their revenue. We need absolute transparency to utilize evidence with trust.

  9. OpenTrials: towards a collaborative open database of all available information on all clinical trials.

    Science.gov (United States)

    Goldacre, Ben; Gray, Jonathan

    2016-04-08

    OpenTrials is a collaborative and open database for all available structured data and documents on all clinical trials, threaded together by individual trial. With a versatile and expandable data schema, it is initially designed to host and match the following documents and data for each trial: registry entries; links, abstracts, or texts of academic journal papers; portions of regulatory documents describing individual trials; structured data on methods and results extracted by systematic reviewers or other researchers; clinical study reports; and additional documents such as blank consent forms, blank case report forms, and protocols. The intention is to create an open, freely re-usable index of all such information and to increase discoverability, facilitate research, identify inconsistent data, enable audits on the availability and completeness of this information, support advocacy for better data and drive up standards around open data in evidence-based medicine. The project has phase I funding. This will allow us to create a practical data schema and populate the database initially through web-scraping, basic record linkage techniques, crowd-sourced curation around selected drug areas, and import of existing sources of structured and documents. It will also allow us to create user-friendly web interfaces onto the data and conduct user engagement workshops to optimise the database and interface designs. Where other projects have set out to manually and perfectly curate a narrow range of information on a smaller number of trials, we aim to use a broader range of techniques and attempt to match a very large quantity of information on all trials. We are currently seeking feedback and additional sources of structured data.

  10. Prevention of abdominal wound infection (PROUD trial, DRKS00000390: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Heger Ulrike

    2011-11-01

    Full Text Available Abstract Background Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating. Methods/Design The PROUD trial is designed as a randomised, controlled, observer, surgeon and patient blinded multicenter superiority trial with two parallel groups and a primary endpoint of wound infection during 30 days after surgery. The intervention group will receive triclosan coated polydioxanone sutures, whereas the control group will receive the standard polydioxanone sutures; abdominal closure will otherwise be standardized in both groups. Statistical analysis is based on intention-to-treat population via binary logistic regression analysis, the total sample size of n = 750 is sufficient to ensure alpha = 5% and power = 80%, an interim analysis will be carried out after data of 375 patients are available. Discussion The PROUD trial will yield robust data to determine the effectiveness of antibacterial coating in one of the standard sutures for abdominal closure and potentially lead to amendment of current guidelines. The exploration of clinically objective parameters as well as quality of life holds immediate relevance for clinical management and the pragmatic trial design ensures high external validity. Trial Registration The trial protocol has been registered with the German Clinical Trials Register (DRKS00000390.

  11. Shoulder Arthroplasty Trials Are Infrequently Registered: A Systematic Review of Trials

    Science.gov (United States)

    Sanchez, Zachary Carter; Herrington, James Murphy; Hensel, James Barrett; Henning, Nolan Michael; Scheckel, Caleb Josiah; Vassar, Matt

    2016-01-01

    Introduction With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals. Methods All randomized trials involving human subjects, pertaining to shoulder arthroplasty, published between July 1, 2005 and December 31, 2015, and indexed in either PubMed or SportDISCUS were analyzed. We assessed the prevalence of registration, the timing of registration relative to patient enrollment periods, and the variable rates of orthopedic journal compliance with ICMJE and Food and Drug Administration clinical registration standards for our study. Results Of the 382 articles identified, 345 (90.3%) were excluded due to failure to meet inclusion criteria. From the remaining 37, only 12 (32.4%) studies were found to be registered in a trial registry. Ten (10/12, 83.3%) of these provided their registration information within the body of the article. None of the included studies from ICMJE-recognized journals were registered. From 34 included studies from non-ICMJE recognized journals, 12 (35.3%) were registered. Conclusion The level of compliance with clinical trial registration guidelines in the decade since their release among shoulder arthroplasty trials in orthopedic journals is poor. Given the importance of the issue, the prevalence of the problem, and the fact that many other medical specialties have already made efforts to improve ICMJE compliance, further work on the part of orthopedic surgery journal authors and editors is needed to ensure the publication of unbiased results. Trial Registration UMIN000022487 PMID:27764210

  12. [Ethical aspects of randomized clinical trials].

    Science.gov (United States)

    Bartoli, E; Sorrentino, D; Trevisi, A

    1997-01-01

    Randomized clinical trials represent the final, essential link between basic medical research and human health. However, their conduction presents very complex ethical problems, since the patient is the actual target of the experiment. Proper randomization, informed consent, and preliminary disclosure of results create deep ethical conflicts between the role of caretaker and that of impartial observer, both played by the same doctor. The dilemma reproduces the conflict between two different ethics. One is based on the inalienable individual rights stemming from the concept of man as an end in himself and not a means to an end. The other, derived from utilitarian philosophies, is based on the benefit for society as a whole. If we agree that randomized clinical trials represent the best method to test the validity of a new treatment, there is no easy solution. The dilemma could be solved by separating the role of the family doctor, committed to the best treatment possible for his patient, from the role of the scientist, committed to the progress of science and humanity. The former is involved in the treatment of individual patients, the latter in clinical and scientific experiments of a therapeutic nature. The patient may trade his rights to the best possible cure for the safety and the efficiency guaranteed by the scientific institution conducting the trial. Trials on relevant issues--expected to produce important results and impeccably designed scientifically--could be endowed with the ethics of science per se and this could be considered equivalent to the individual rights waived by the patient.

  13. Trial Manufacture of Core Subassemblies of CEFR

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    Engineering department of CEFR selected factories to research manufacturing process of subassemblies in March 2001. By November 2001, the trial productions of several materials have been completed. Meanwhile two B4C shielding subassemblies and two support legs of steel reflecting subassembly, which are used in hydrodynamic and structural stability out-of-pile tests, and three B4C rods which are irradiated in-pile have been assembled.

  14. The Postoperative Pain Assessment Skills Pilot Trial

    Directory of Open Access Journals (Sweden)

    Michael McGillion

    2011-01-01

    Full Text Available BACKGROUND/OBJECTIVES: Pain-related misbeliefs among health care professionals (HCPs are common and contribute to ineffective postoperative pain assessment. While standardized patients (SPs have been effectively used to improve HCPs’ assessment skills, not all centres have SP programs. The present equivalence randomized controlled pilot trial examined the efficacy of an alternative simulation method – deteriorating patient-based simulation (DPS – versus SPs for improving HCPs’ pain knowledge and assessment skills.

  15. Northwestern University trial emerging optical solutions

    CERN Multimedia

    2001-01-01

    Nortel Networks, SBC Ameritech and Northwestern University announced the creation of OMNInet (Optical Metro Network Initiative), a collaborative experimental network. The OMNInet technology trial, a four-site network located in Chicago, will provide a test bed for all-optical switching, advanced high-speed technology such as 10 gigabit Ethernet (10GE) and will test next-generation applications in healthcare, industrial design, finance and commerce.

  16. Analysis of angiographic trial data in women.

    Science.gov (United States)

    Havel, R J

    1994-01-01

    There are few angiographic trials of cholesterol lowering in women. Two trials have included a sufficient number of women for meaningful assessment of lesion change, as determined by quantitative coronary angiography. In the University of California, San Francisco Specialized Center of Research in Arteriosclerosis (UCSF SCOR) trial, 72 patients (57% women) with familial hypercholesterolaemia (90% of whom had no overt coronary heart disease) were randomised to receive either diet and intensive drug therapy (combinations of colestipol, nicotinic acid and lovastatin) or diet and modest doses of colestipol, according to baseline low density lipoprotein cholesterol level. Coronary angiograms were obtained at 2-year intervals. Change in percentage area of stenosis (the primary end-point) in women receiving intensive drug treatment was -2.06% compared with +1.07% for the controls (p = 0.05). For the intensively treated men, corresponding values were -0.88% compared with +0.41% for the controls (difference not significant). In a recently completed trial in Canada, 269 men and 62 women with established coronary heart disease were randomised to receive either diet alone, or diet and lovastatin (up to 80 mg daily). In men, the increase in percentage diameter of stenosis was reduced by 43% (p = 0.05), and in women by 40% (not significant). By contrast, new lesions appeared in 4% of women assigned to intensive drug treatment, compared with 45% of those randomised to diet (p < 0.001). In men, new lesions appeared in 18% and 29% of patients, respectively (p = 0.047). These data suggest that coronary artery lesions in women respond at least as well as those in men to cholesterol lowering.

  17. Trial of Immune Globulin in Infant Botulism

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2006-02-01

    Full Text Available A 5-year, randomized, double-blind, placebo-controlled trial of the orphan drug Human Botulism Immune Globulin Intravenous (BIG-IV in 122 infants in California with confirmed infant botulism (75 caused by type A Clostridium botulinum toxin, and 47 by type B toxin was conducted at the California Department of Health Services, Richmond, CA; National Botulism Surveillance and Reference Laboratory, CDC and P, Atlanta; and Division of Biostatistics, University of California, Berkeley.

  18. Characteristics of randomised trials on diseases in the digestive system registered in ClinicalTrials.gov: a retrospective analysis

    DEFF Research Database (Denmark)

    Wildt, Signe; Krag, Aleksander; Gluud, Liselotte

    2011-01-01

    Objectives To evaluate the adequacy of reporting of protocols for randomised trials on diseases of the digestive system registered in http://ClinicalTrials.gov and the consistency between primary outcomes, secondary outcomes and sample size specified in http://ClinicalTrials.gov and published...

  19. On Trial. A Criminal Trial Simulation--The Case of the Big Bad Wolf. Grades 4-6.

    Science.gov (United States)

    Schweitzer, Margaret

    Designed for teachers, this simulation of a criminal trial addresses the workings of the trial system by using the children's story, "The Three Little Pigs." The Big Bad Wolf is put on trial for destroying the pigs' houses. By having students assume roles and use the non-scripted character profiles, the simulation allows information to…

  20. Moral justification of Phase 1 oncology trials.

    Science.gov (United States)

    Dubov, Alex

    2014-06-01

    This article attempts to answer the following normative questions: Can one consider the design of Phase 1 trials ethically appropriate due to the unfavorable ratio of risks and benefits? What are some ethical safeguards for Phase 1 oncology research? A comparative review of literature contributed to the consolidation of the proposed ethical framework for Phase 1 oncology trials. This framework gives a special attention to issues of therapeutic misconception and vulnerability. The benefits and dangers associated with the enrollment in trials are described as well as the absence of alternatives, treatment-specific optimism, and vagueness in factual presentation during the informed consent process. The notion of therapeutic misconception is contrasted with optimism despite realism that stems from psychological, cultural, and religious factors and not necessarily from the lack of information. Close attention is given to the possible ways in which the inherent uncertainty and resulting cognitive biases may affect the informed consent process and the definition of therapeutic misconception. The article ends with recommendations for an ethical way of enrolling palliative patients in early stages of oncology research, giving special attention to provision of adequate consent, protection of vulnerability, and avoidance of therapeutic misconception.

  1. Privacy and confidentiality in pragmatic clinical trials.

    Science.gov (United States)

    McGraw, Deven; Greene, Sarah M; Miner, Caroline S; Staman, Karen L; Welch, Mary Jane; Rubel, Alan

    2015-10-01

    With pragmatic clinical trials, an opportunity exists to answer important questions about the relative risks, burdens, and benefits of therapeutic interventions. However, concerns about protecting the privacy of this information are significant and must be balanced with the imperative to learn from the data gathered in routine clinical practice. Traditional privacy protections for research uses of identifiable information rely disproportionately on informed consent or authorizations, based on a presumption that this is necessary to fulfill ethical principles of respect for persons. But frequently, the ideal of informed consent is not realized in its implementation. Moreover, the principle of respect for persons—which encompasses their interests in health information privacy—can be honored through other mechanisms. Data anonymization also plays a role in protecting privacy but is not suitable for all research, particularly pragmatic clinical trials. In this article, we explore both the ethical foundation and regulatory framework intended to protect privacy in pragmatic clinical trials. We then review examples of novel approaches to respecting persons in research that may have the added benefit of honoring patient privacy considerations.

  2. 76 FR 51375 - Dialogues in Diversifying Clinical Trials: Successful Strategies for Engaging Women and...

    Science.gov (United States)

    2011-08-18

    ... HUMAN SERVICES Food and Drug Administration Dialogues in Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials AGENCY: Food and Drug Administration, HHS... Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials....

  3. [PDCA Applied in Special Rectification of Medical Instrument Clinical Trial].

    Science.gov (United States)

    Wang, Lei; Qu, Xintao; Yu, Xiuchun

    2015-09-01

    PDCA cycle was applied in special rectification activities for medical instrument clinical trial, with quality criteria of implementation made. Completed medical instrument clinical trial from January 2011 to December 2012 was believed as control group, from January 2013 to December 2014 as PDCA group, the scores of clinical trial and the score rate of items were compared and analyzed. Results show quality scores of clinical trial in PDCA group are higher than that in control group (51 vs. 81, P rectification activities with PDCA applied in our department are feasible and effective. It significantly improves implement quality of medical instrument clinical trial.

  4. Globalization of clinical trials - where are we heading?

    Science.gov (United States)

    George, Melvin; Selvarajan, Sandhiya; S, Suresh-Kumar; Dkhar, Steven A; Chandrasekaran, Adithan

    2013-05-01

    The last decade has witnessed a greater transparency in clinical research with the advent of clinical trial registries. The aim of the study was to describe the trends in the globalization of clinical trials in the last five years. We performed an internet search using the WHO International clinical trials registry platform (WHO ICTRP) to identify the clinical trials conducted from January 2007 to December 31, 2011 among 25 countries. Among the 25 countries, the United States, Japan and Germany occupy the top positions in the total number of clinical trials conducted. Clinical trials in the US (36312) constituted 31.5% of the total number of trials performed during this period. However over a period of five years both US and Western Europe appear to show a decline, while the emerging countries show a rise in clinical trials registered. Among the emerging countries China, India and Republic of Korea are most active regions involved in clinical trials. Cancer, diabetes and respiratory diseases were most widely researched areas overall. Although the study confirms the transition in the clinical trials research towards emerging countries, the developed regions of the world still contribute to more than 70% of the trials registered worldwide.

  5. Improving the operational efficiency of Phase 2 and 3 trials.

    Science.gov (United States)

    Ganju, Jitendra

    2016-07-20

    The period toward the end of patients' participation in late stage blinded clinical trials is highly resource intensive for the sponsor. Consider first a Phase 3 trial. If the trial is a success, the sponsor has to implement the next steps, which might be filing for approval of the drug with the US Food and Drug Administration (FDA). To shorten the time interval between trial completion and submission of the package to the FDA, sponsors front-load as much work as is possible at risk. The approach is efficient if the trial succeeds but is inefficient if it fails. For a failed trial, the sponsor is unlikely to proceed with the plan that assumed success. Phase 2 trials are also at risk of being inefficient. Many activities, such as planning for drug interaction studies, thorough QT studies, or site selection for Phase 3 trials, are set in motion prior to completion of the Phase 2 trial. The work going on in parallel is wasted if the trial fails. The proposal to improve the efficiency is to let an independent entity provide the sponsor critical information at an earlier time necessary to reevaluate activities ongoing in parallel and external to the trial.

  6. Electronic Cigarette Trial and Use among Young Adults: Reasons for Trial and Cessation of Vaping

    Directory of Open Access Journals (Sweden)

    Lois Biener

    2015-12-01

    Full Text Available This paper identifies predictors of trial and current use, and reasons for trying and ceasing use of electronic cigarettes (e-cigarettes among young adults, with particular attention to former and never smokers. Data are from a mail survey of a population-based sample of adults aged 18 to 35 (N = 4740 in three U.S. metropolitan areas. Survey items assessed trial and use of e-cigarettes, cigarette smoking status, and reasons for trial and for ceasing use of e-cigarettes. Almost 23% reported trial of e-cigarettes, and 8.4% reported using them in the past month. Current smokers were much more likely to have tried e-cigarettes (70.2% than both former (32.3% and never smokers (7.6%; p < 0.001 and to have used them in the past month (30.8%, 10.1%, 2.0% respectively; p < 0.001. Smoking status and scores on sensation seeking were significant independent predictors of both trial and current use of e-cigarettes. Never-smokers cite curiosity as the reason for trying e-cigarettes and also that their friends used them. The most frequent reason for ceasing use among never and former smokers was health concerns. For virtually none of them were e-cigarettes their first exposure to nicotine.

  7. Metacognition of Working Memory Performance: Trial-by-Trial Subjective Effects from a New Paradigm.

    Science.gov (United States)

    Garcia, Andrew C; Bhangal, Sabrina; Velasquez, Anthony G; Geisler, Mark W; Morsella, Ezequiel

    2016-01-01

    Investigators have begun to examine the fleeting urges and inclinations that subjects experience when performing tasks involving response interference and working memory. Building on this research, we developed a paradigm in which subjects, after learning to press certain buttons when presented with certain letters, are presented with two action-related letters (the memoranda) but must withhold responding (4 s) until cued to emit the response associated with only one of the two letters. In the Congruent condition, the action corresponds to the cue (e.g., memoranda = AB, cue = B, response = B); in the Incongruent condition, the action corresponds to the other item of the memoranda (e.g., memoranda = AB, cue = B, response = A). After each trial, subjects inputted a rating regarding their subjectively experienced "urge to err" on that trial. These introspection-based data revealed that, as found in previous research, urges to err were strongest for incongruent trials. Our findings reveal, first, that subjects can successfully perform this new task, even though it is more complex than that of previous studies, and second, that, in this new paradigm, reliable subjective, metacognitive data can be obtained on a trial-by-trial basis. We hope that our novel paradigm will serve as a foundation for future experimental projects on the relationship between working memory performance and consciousness-an under-explored nexus whose investigation is likely to reveal insights about working memory, cognitive control, and metacognition.

  8. Trial-by-trial adjustments of top-down set modulate oculomotor capture.

    Science.gov (United States)

    Moher, Jeff; Abrams, Jared; Egeth, Howard E; Yantis, Steven; Stuphorn, Veit

    2011-10-01

    The role of top-down control in visual search has been a subject of much debate. Recent research has focused on whether attentional and oculomotor capture by irrelevant salient distractors can be modulated through top-down control, and if so, whether top-down control can be rapidly initiated based on current task goals. In the present study, participants searched for a unique shape in an array containing otherwise homogeneous shapes. A cue prior to each trial indicated the probability that an irrelevant color singleton distractor would appear on that trial. Initial saccades were less likely to land on the target and participants took longer to initiate a saccade to the target when a color distractor was present than when it was absent; this cost was greatly reduced on trials in which the probability that a distractor would appear was high, as compared to when the probability was low. These results suggest that top-down control can modulate oculomotor capture in visual search, even in a singleton search task in which distractors are known to readily capture both attention and the eyes. Furthermore, the results show that top-down distractor suppression mechanisms can be initiated quickly in anticipation of irrelevant salient distractors and can be adjusted on a trial-by-trial basis.

  9. Trial-by-trial identification of categorization strategy using iterative decision-bound modeling.

    Science.gov (United States)

    Hélie, Sébastien; Turner, Benjamin O; Crossley, Matthew J; Ell, Shawn W; Ashby, F Gregory

    2016-08-05

    Identifying the strategy that participants use in laboratory experiments is crucial in interpreting the results of behavioral experiments. This article introduces a new modeling procedure called iterative decision-bound modeling (iDBM), which iteratively fits decision-bound models to the trial-by-trial responses generated from single participants in perceptual categorization experiments. The goals of iDBM are to identify: (1) all response strategies used by a participant, (2) changes in response strategy, and (3) the trial number at which each change occurs. The new method is validated by testing its ability to identify the response strategies used in noisy simulated data. The benchmark simulation results show that iDBM is able to detect and identify strategy switches during an experiment and accurately estimate the trial number at which the strategy change occurs in low to moderate noise conditions. The new method is then used to reanalyze data from Ell and Ashby (2006). Applying iDBM revealed that increasing category overlap in an information-integration category learning task increased the proportion of participants who abandoned explicit rules, and reduced the number of training trials needed to abandon rules in favor of a procedural strategy. Finally, we discuss new research questions made possible through iDBM.

  10. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies

    Directory of Open Access Journals (Sweden)

    Francis David

    2006-04-01

    Full Text Available Abstract Background A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC and the Health Technology Assessment (HTA Programme. Methods The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. Results Less than a third (31% of the trials achieved their original recruitment target and half (53% were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41% trials and early recruitment problems were identified in 77 (63% trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. Conclusion Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds. While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.

  11. Design and Validity of Randomized Controlled Dental Restorative Trials

    Directory of Open Access Journals (Sweden)

    Gerd Göstemeyer

    2016-05-01

    Full Text Available Background: The evidence stemming from trials on restorative materials is shaped not only by trial findings, but also trial design and validity. We aimed to evaluate both aspects in randomized controlled dental restorative trials published from 2005–2015. Methods: Using systematic review methodology, we retrieved trials comparing restorative or adhesive dental materials. Two authors independently assessed design, risk of bias, registration status, and findings of trials. Descriptive and regression analyses were performed. Results: 114 studies on 15,321 restorations placed mainly in permanent teeth of 5232 patients were included. Per trial, the median number of patients was 37 (25th/75th percentiles: 30/51. Follow-up was 24 (20/48 months. Seventeen percent of trials reported on sample size calculations, 2% had been registered. Most trials (90% used US Public Health Service (USPHS criteria, and had a high risk of bias. More recent trials were more likely to have been registered, to have reported on sample size calculations, to be of low risk of bias, and to use other than USPHS-criteria. Twenty-three percent of trials yielded significant differences between groups. The likelihood of such differences was significantly increased in older studies, studies with potential reporting bias, published in journals with high impact factor (>2, longer follow-up periods, and not using USPHS-criteria. Conclusions: The majority of dental restorative trials published from 2005–2015 had limited validity. Risk of bias decreased in more recent trials. Future trials should aim for high validity, be registered, and use defined and appropriate sample sizes, follow-up periods, and outcome measures.

  12. Acute HIV Infection | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available HRA A.2EudraCT number2011-001982-42 A.3Full title of the trial Investigation of a novel intervention in Acute..., i.e. non-technical, language A study of the effect of antiretroviral therapy and immunoglobulin on the HIV reservoir in Acute... of a novel intervention in Acute HIV Infection (AHI) A.4.1Sponsor's protocol code numberJ004 A.7Trial is pa...nformation on the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute... HIV Infection E.1.1.1Medical condition in easily understood language Acute

  13. Trial-to-trial adaptation in control of arm reaching and standing posture.

    Science.gov (United States)

    Pienciak-Siewert, Alison; Horan, Dylan P; Ahmed, Alaa A

    2016-12-01

    Classical theories of motor learning hypothesize that adaptation is driven by sensorimotor error; this is supported by studies of arm and eye movements that have shown that trial-to-trial adaptation increases with error. Studies of postural control have shown that anticipatory postural adjustments increase with the magnitude of a perturbation. However, differences in adaptation have been observed between the two modalities, possibly due to either the inherent instability or sensory uncertainty in standing posture. Therefore, we hypothesized that trial-to-trial adaptation in posture should be driven by error, similar to what is observed in arm reaching, but the nature of the relationship between error and adaptation may differ. Here we investigated trial-to-trial adaptation of arm reaching and postural control concurrently; subjects made reaching movements in a novel dynamic environment of varying strengths, while standing and holding the handle of a force-generating robotic arm. We found that error and adaptation increased with perturbation strength in both arm and posture. Furthermore, in both modalities, adaptation showed a significant correlation with error magnitude. Our results indicate that adaptation scales proportionally with error in the arm and near proportionally in posture. In posture only, adaptation was not sensitive to small error sizes, which were similar in size to errors experienced in unperturbed baseline movements due to inherent variability. This finding may be explained as an effect of uncertainty about the source of small errors. Our findings suggest that in rehabilitation, postural error size should be considered relative to the magnitude of inherent movement variability.

  14. Pre-trial evaluation of the potential for unblinding in drug trials: a prototype example.

    Science.gov (United States)

    Walter, S D; Awasthi, Shally; Jeyaseelan, L

    2005-08-01

    Blinding is an important design feature of randomised trials that may reduce bias in the results, compared to the situation where blinding is not possible or is not maintained. The literature provides some guidance for the evaluation of blinding in ongoing or completed studies, but the question of pre-trial assessment of the potential for unblinding has not been addressed. This paper describes the design and analysis of a prototype experiment for the pre-trial assessment of blinding in a drug trial. This work was motivated by a trial using antibiotic therapy, in which the investigators were concerned about the possibility of subjects being able to differentiate active medication from placebo, and thus become unblinded to their treatment assignment. A small experiment was mounted in which participants had to divide a random mixture of tablets into two groups. Statistical methods were developed to calculate the probability of a given number of similar tablets being classified into the same group by chance, with a modification to allow for some participants having constrained their responses to have equal numbers of tablets in each group. Differentiation of tablets by taste (the initial concern of the investigators) was not statistically different from chance. A smaller set of data on differentiation by appearance (a possibility not originally considered) had borderline statistical significance. After reviewing all these results, the investigators decided to proceed with the study without modifying the tablets, in part because subjects in the study would be unlikely to compare the two types of medication side-by-side. Our results suggest that blinding might sometimes be compromised in unexpected ways. Whenever possible, we suggest that similar and larger such experiments be carried out before the trial to assess whether blinding might be compromised. The methods proposed here could easily be adapted to evaluate the results of such experiments.

  15. Ethical pitfalls in neonatal comparative effectiveness trials.

    Science.gov (United States)

    Modi, Neena

    2014-01-01

    oxygen that are too low or too high. Investigators in the UK, Australia, New Zealand and the USA designed randomized controlled trials to provide more precise guidance, by determining whether targeting the lower end of the accepted range (85-89%) resulted in reduced retinopathy of prematurity when compared with the upper end of the accepted range (91-95%). Between 2004 and 2009, the US SUPPORT trial (Surfactant, Positive Pressure and Oxygenation Randomized Trial) recruited approximately 1,300 infants and showed that babies at the higher end of the recommended oxygen saturation range had a greater incidence of retinopathy of prematurity, but that, unexpectedly, babies at the lower end had a higher risk of death [1]. The data monitoring committees of the BOOST II (Oxygen Saturation and Outcomes in Preterm Infants) trials in the UK, Australia and New Zealand reviewed their interim data, confirmed the higher risk of death in babies randomized to the lower saturation range, and halted further recruitment [2]. Without the trials, the lower saturation target would have continued to be applied to many babies, and many would have died as a result. Though many uncertainties remain, the trials facilitated advances in care. However, in March 2013, the lead investigators for the SUPPORT trial were informed by the US 'Office for Human Research Protections' that they were 'in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death' [3]. This extraordinary conclusion indicates that the US regulators considered the researchers to be at fault for failing to foresee an unexpected trial result, and for randomizing babies to receive oxygen within the accepted standard-of-care limits. The ruling further implies that the regulators consider that clinicians are acting ethically when they deliver an accepted but non-evidence-based treatment based upon their personal bias, but

  16. Leucemia Mieloide Aguda de novo | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available te ConcernedSpain - AEMPS A.2EudraCT number2012-000233-39 A.3Full title of the trial Tratamiento de la leucemia...a A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language Tratamiento de la leucemia...on quimioterapia distinta de hidroxiurea.Leucemia promielocítica aguda con t(15;17).Crisis blástica de la leucemia...l valor límite normal, excepto cuando la alteraciones sean atribuibles a la leucemia. Pacientes con fracción

  17. Empowering natural clinical trial advocates: nurses and outreach workers.

    Science.gov (United States)

    Mitschke, Diane B; Cassel, Kevin; Higuchi, Paula

    2007-03-01

    Cancer clinical trials are essential to advancing the prevention and treatment of cancer, yet adult participation rates in clinical trials remain abysmal. Despite the essential contributions of clinical trials to science and medicine, adult participation in clinical trials remains exceedingly low, with only 2%-4% of all adult patients with cancer in the U.S. participating in clinical trials. Clinical trials accrual rates in Hawai'i follow this national trend of less than 3% of eligible patients participating in trials. Recognizing the need to increase awareness about clinical trials, the National Cancer Institute's Cancer Information Service-Pacific Region, through the Hawai'i Clinical Trials Education Coalition, has employed strategic dissemination plans to train and educate key target audiences, including registered nurses, nursing students, and community outreach workers about the availability of over 90 cancer clinical trials in Hawai'i. Previous research suggests that nurses often play a vital role in increasing a patient's understanding of clinical trials and may also act as a patient advocate in regards to participation in a clinical trial. A train-the-trainer model curriculum was developed using the Clinical Trials Education Series (CTES), a collection of multi-level resources designed by the National Cancer Institute, to educate various constituents about clinical trials. The training curriculum and workshop format is adapted based on both formal and informal needs assessments conducted with audiences prior to the planned training, yet key elements remain central to the training model. In addition, an interactive, internet-based case study was developed using local place names and cultural cues to allow training participants to engage in realistic and practical methods for locating and sharing information about clinical trials with patients and the public. This training model has been implemented in a variety of settings including three statewide nursing

  18. A matched crossover design for clinical trials.

    Science.gov (United States)

    Simon, Laura J; Chinchilli, Vernon M

    2007-09-01

    Two design principles are used frequently in clinical trials: 1) A subject is "matched" or "paired" with a similar subject to reduce the chance that other variables obscure the primary comparison of interest. 2) A subject serves as his/her own control by "crossing over" from one treatment to another during the course of an experiment. There are situations in which it may be advantageous to use the two design principles - crossing over and matching - simultaneously. That is, it may be advantageous to conduct a "paired crossover design," in which each subject, while paired with a similar subject, crosses over and receives each experimental treatment. In this paper, we describe two clinical trials conducted by the National Heart, Lung and Blood Institute's Asthma Clinical Research Network that used a paired 2x2 crossover design. The Beta Adrenergic Response by GEnotype (BARGE) Study compared the effects of regular use of inhaled albuterol on mildly asthmatic patients with different genotypes at the 16th position of the beta-agonist receptor gene. The Smoking Modulates Outcomes of Glucocorticoid (SMOG) Therapy in Asthma Study evaluated the hypothesis that smoking reduces the response to inhaled corticosteroids. For such paired crossover designs, the primary parameter of interest is typically the treatment-by-pairing interaction term. In evaluating the relative efficiency of the paired 2x2 crossover design to two independent crossover designs with respect to this interaction term, we show that the paired 2x2 crossover design is more efficient if the correlations between the paired members on the same treatments are greater than their correlations on different treatments. This condition should hold in most circumstances, and therefore the paired crossover design deserves serious consideration for any clinical trial in which the crossing over and matching of subjects is deemed simultaneously beneficial.

  19. The Electronic Evidence in Trial Proceedings

    Directory of Open Access Journals (Sweden)

    Monica Pocora

    2015-05-01

    Full Text Available This paper will consider theoretical and practical issues which arise in trial proceedings, throughout the virtual presence of persons involved. The EU Convention of 2000 provide the legal base for the use of video conference. In most jurisdictions, all forms of evidence is admissible, subject to rules relating to the exclusion of evidence because of improper actions or because the inclusion of the evidence would be unfair to the defendant. There is a difference between the admissibility of the evidence and laying the correct foundations before the evidence can be admitted.

  20. Eurados trial performance test for photon dosimetry

    DEFF Research Database (Denmark)

    Stadtmann, H.; Bordy, J.M.; Ambrosi, P.

    2001-01-01

    Within the framework of the EURADOS Action entitled Harmonisation and Dosimetric Quality Assurance in Individual Monitoring for External Radiation, trial performance tests for whole-body and extremity personal dosemeters were carried out. Photon, beta and neutron dosemeters were considered....... This paper summarises the results of the whole-body photon dosemeter test. Twenty-six dosimetry services from all EU Member States and Switzerland participated. Twelve different radiation fields were used to simulate various workplace irradiation fields. Dose values from 0.4 mSv to 80 mSv were chosen. From...

  1. Information and punitiveness: trial reconstruction in Ireland

    OpenAIRE

    M. Sato; Hough, Mike

    2015-01-01

    Purpose of this paper: to report results from a rape trial reconstruction in Ireland \\ud \\ud Design/methodology/approach: A studio audience of 100 members of the Irish public were selected to attend a TV programme by the Republic of Ireland’s national broadcasting organisation (RTÉ). This involved the examination of the sentencing of a rape case. The audience’s sentencing preferences were measured at the outset, when they had been given only summary information about the case, and later, when...

  2. THE PRE-TRIAL CHAMBER JUDGE

    Directory of Open Access Journals (Sweden)

    Edgar Laurentiu DUMBRAVA

    2014-12-01

    Full Text Available The importance of this work lies in important changes in the new Code of Criminal Procedure, amendments justified by the new realities of a democratic society in which criminal procedural rules must be adapted according to the daily realities in the achievement of justice. The purpose of the paper is given by the need of approaching at a theoretically level the institution of The Pre-Trial Chamber Judge, given that so far there have not been developed any works on the subject. This paper addresses both practitioners and litigants.

  3. THE PRE-TRIAL CHAMBER JUDGE

    Directory of Open Access Journals (Sweden)

    Edgar Laurenţiu DUMBRAVĂ

    2014-05-01

    Full Text Available The importance of this work lies in important changes in the new Code of Criminal Procedure, amendments justified by the new realities of a democratic society in which criminal procedural rules must be adapted according to the daily realities in the achievement of justice. The purpose of the paper is given by the need of approaching at a theoretically level the institution of The Pre-Trial Chamber Judge, given that so far there have not been developed any works on the subject. This paper addresses both practitioners and litigants.

  4. Ethical issues in postauthorization drug trials

    OpenAIRE

    Bernabe, R.D.L.C.

    2013-01-01

    This thesis is an attempt to raise some ethical issues that are specific to phase IV drug trials and to provide preliminary responses to such issues. We limited ourselves to issues of informed consent, risk-benefit assessment, and the therapeutic orientation of phase IV. On the issue of informed consent (IC) and phase IV, we deliberated on issues related to form and procedure. First, we demonstrated that in phase IV non-interventional studies, though IC remains the standard, the manner of col...

  5. Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology.

    Science.gov (United States)

    Palevsky, Paul M; Molitoris, Bruce A; Okusa, Mark D; Levin, Adeera; Waikar, Sushrut S; Wald, Ron; Chertow, Glenn M; Murray, Patrick T; Parikh, Chirag R; Shaw, Andrew D; Go, Alan S; Faubel, Sarah G; Kellum, John A; Chinchilli, Vernon M; Liu, Kathleen D; Cheung, Alfred K; Weisbord, Steven D; Chawla, Lakhmir S; Kaufman, James S; Devarajan, Prasad; Toto, Robert M; Hsu, Chi-yuan; Greene, Tom; Mehta, Ravindra L; Stokes, John B; Thompson, Aliza M; Thompson, B Taylor; Westenfelder, Christof S; Tumlin, James A; Warnock, David G; Shah, Sudhir V; Xie, Yining; Duggan, Emily G; Kimmel, Paul L; Star, Robert A

    2012-05-01

    Acute kidney injury (AKI) remains a complex clinical problem associated with significant short-term morbidity and mortality and lacking effective pharmacologic interventions. Patients with AKI experience longer-term risks for progressive chronic ESRD, which diminish patients' health-related quality of life and create a larger burden on the healthcare system. Although experimental models have yielded numerous promising agents, translation into clinical practice has been unsuccessful, possibly because of issues in clinical trial design, such as delayed drug administration, masking of therapeutic benefit by adverse events, and inadequate sample size. To address issues of clinical trial design, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored a workshop titled "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" in December 2010. Workshop participants included representatives from academia, industry, and government agencies whose areas of expertise spanned basic science, clinical nephrology, critical care medicine, biostatistics, pharmacology, and drug development. This document summarizes the discussions of collaborative workgroups that addressed issues related to patient selection, study endpoints, the role of novel biomarkers, sample size and power calculations, and adverse events and pilot/feasibility studies in prevention and treatment of AKI. Companion articles outline the discussions of workgroups for model trials related to prevention or treatment of established AKI in different clinical settings, such as in patients with sepsis.

  6. Recruiting Dementia Caregivers Into Clinical Trials: Lessons Learnt From the Australian TRANSCENDENT Trial.

    Science.gov (United States)

    Leach, Matthew J; Ziaian, Tahereh; Francis, Andrew; Agnew, Tamara

    2016-01-01

    The burden on those caring for a person with dementia is substantial. Although quality research assists in addressing the needs of these caregivers, recruiting caregivers into clinical studies is often problematic. This investigation explores the difficulties and successes in recruiting dementia caregivers into community-based clinical research by reporting the findings of a mixed-method substudy of a multicenter randomized controlled trial involving 40 community-dwelling dementia caregivers living in Adelaide, South Australia. Data for the substudy were derived from standardized trial monitoring documentation and structured telephone interviews. From a total of 16 distinct methods used across a 12-month recruitment campaign, the most cost-effective strategy was the distribution of flyers through a single study site. This approach generated the greatest number of enrollments of all methods used, achieving a 67% recruitment yield. The least cost-effective strategy, with a 0% recruitment yield, was the publication of a newspaper advertisement. Themes that emerged from the interviews pointed toward 5 key facilitators and 3 barriers to future trial recruitment. This study has generated new insights into the effective recruitment of dementia caregivers into clinical trials. We anticipate that these lessons learnt will assist in shaping the recruitment strategies of future studies of dementia caregivers.

  7. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial : a multicentre, randomised, placebo-controlled, phase III trial

    NARCIS (Netherlands)

    den Hertog, Heleen M.; van der Worp, H. Bart; van Gemert, H. Maarten A.; Algra, Ate; Kappelle, L. Jaap; Van Gijn, Jan; Koudstaal, Peter J.; Dippel, Diederik W. J.

    2009-01-01

    Background High body temperature in the first 12-24 h after stroke onset is associated with poor functional outcome. The Paracetamol (Acetaminophen) In Stroke (PAIS) trial aimed to assess whether early treatment with paracetamol improves functional outcome in patients with acute stroke by reducing b

  8. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  9. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    Science.gov (United States)

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  10. Potential of adaptive clinical trial designs in pharmacogenetic research, A simulation based on the IPASS trial

    NARCIS (Netherlands)

    Van Der Baan, Frederieke H.; Knol, Mirjam J.; Klungel, Olaf H.; Egberts, Toine C.G.; Grobbee, Diederick E.; Roes, Kit C.B.

    2011-01-01

    Background: An adaptive clinical trial design that allows population enrichment after interim analysis can be advantageous in pharmacogenetic research if previous evidence is not strong enough to exclude part of the patient population beforehand.With this design, underpowered studies or unnecessary

  11. Acute pulmonary embolism | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute... pulmonary embolism Embolismo pulmonar agudo E.1.1.1Medical condition in easily understood language Acute...rial contains a sub-study No E.3Principal inclusion criteria 1) Acute symptomatic PE confirmed by multidetec

  12. Acute Optic Neuritis | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available on the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute... Optic Neuritis E.1.1.1Medical condition in easily understood language Acute Optic Neuritis E.1.1.2T

  13. Acute ischaemic stroke | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available nguage Imatinib Treatment in Acute Ischemic Stroke A.4.1Sponsor's protocol code numberIstrokepilot A.7Trial ...Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute....g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy) or other haemorrhagic ophthalmic conditions - Acute

  14. Acute myocardial infarction | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available Information on the Trial E.1 Medical condition or disease under investigation E.1.1Medical condition(s) being investigated Acute...vestigation E.1.2Version 9.1 E.1.2Level LLT E.1.2Classification code 10000891 E.1.2Term Acute

  15. Postoperative pulmonary artery hypertension | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available n el postoperatorio de cirugia cardiaca en niños. A.3.2Name or abbreviated title of the trial where availabl...non-technical, language sildenafil in the postoperative period of cardiac surgery in children. sildenafilo e

  16. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida;

    2013-01-01

    BACKGROUND:Clinical trials are commonly done without blinded outcome assessors despite the risk of bias. We wanted to evaluate the effect of nonblinded outcome assessment on estimated effects in randomized clinical trials with outcomes that involved subjective measurement scales. METHODS......:We conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two......%). Heterogeneity was moderate (I(2) = 46%, p = 0.02) and unexplained by metaregression. INTERPRETATION:We provide empirical evidence for observer bias in randomized clinical trials with subjective measurement scale outcomes. A failure to blind assessors of outcomes in such trials results in a high risk...

  17. Practical considerations for adaptive trial design and implementation

    CERN Document Server

    Pinheiro, José; Kuznetsova, Olga

    2014-01-01

    This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers.  In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low.  One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, t...

  18. Outcome measures in amyotrophic lateral sclerosis clinical trials

    Science.gov (United States)

    Paganoni, Sabrina; Cudkowicz, Merit; Berry, James D

    2017-01-01

    Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with an average survival of 3–5 years. While therapies for ALS remain limited, basic and translational ALS research has been host to numerous influential discoveries in recent years. These discoveries have led to a large pipeline of potential therapies that await testing in clinical trials. Until recently, ALS clinical trials have relied on a limited cadre of ‘traditional’ outcome measures, including survival and measures of function. These measures have proven useful, although imperfect, in Phase III ALS trials. However, their utility in early-phase ALS trials is limited. For these early trials, outcome measures focused on target engagement or biological pathway analysis might improve trial outcomes and better support the drug development process.

  19. Statistical challenges for central monitoring in clinical trials: a review.

    Science.gov (United States)

    Oba, Koji

    2016-02-01

    Recently, the complexity and costs of clinical trials have increased dramatically, especially in the area of new drug development. Risk-based monitoring (RBM) has been attracting attention as an efficient and effective trial monitoring approach, which can be applied irrespectively of the trial sponsor, i.e., academic institution or pharmaceutical company. In the RBM paradigm, it is expected that a statistical approach to central monitoring can help improve the effectiveness of on-site monitoring by prioritizing and guiding site visits according to central statistical data checks, as evidenced by examples of actual trial datasets. In this review, several statistical methods for central monitoring are presented. It is important to share knowledge about the role and performance capabilities of statistical methodology among clinical trial team members (i.e., sponsors, investigators, data managers, monitors, and biostatisticians) in order to adopt central statistical monitoring for assessing data quality in the actual clinical trial.

  20. The Cessation in Pregnancy Incentives Trial (CPIT: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tappin David M

    2012-07-01

    Full Text Available Abstract Background Seventy percent of women in Scotland have at least one baby, making pregnancy an opportunity to help most young women quit smoking before their own health is irreparably compromised. By quitting during pregnancy their infants will be protected from miscarriage and still birth as well as low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. In the UK, the NICE guidelines: ‘How to stop smoking in pregnancy and following childbirth’ (June 2010 highlighted that little evidence exists in the literature to confirm the efficacy of financial incentives to help pregnant smokers to quit. Its first research recommendation was to determine: Within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit? Design and methods This study is a phase II exploratory individually randomized controlled trial comparing standard care for pregnant smokers with standard care plus the additional offer of financial voucher incentives to engage with specialist cessation services and/or to quit smoking during pregnancy. Participants (n = 600 will be pregnant smokers identified at maternity booking who, when contacted by specialist cessation services, agree to having their details passed to the NHS Smokefree Pregnancy Study Helpline to discuss the trial. The NHS Smokefree Pregnancy Study Helpline will be responsible for telephone consent and follow-up in late pregnancy. The primary outcome will be self reported smoking in late pregnancy verified by cotinine measurement. An economic evaluation will refine cost data collection and assess potential cost-effectiveness while qualitative research interviews with clients and health professionals will assess the level of acceptance of this form of incentive payment. The research questions are: What is the likely therapeutic efficacy? Are incentives potentially cost-effective? Is individual randomization an

  1. Statistical reasoning in clinical trials: hypothesis testing.

    Science.gov (United States)

    Kelen, G D; Brown, C G; Ashton, J

    1988-01-01

    Hypothesis testing is based on certain statistical and mathematical principles that allow investigators to evaluate data by making decisions based on the probability or implausibility of observing the results obtained. However, classic hypothesis testing has its limitations, and probabilities mathematically calculated are inextricably linked to sample size. Furthermore, the meaning of the p value frequently is misconstrued as indicating that the findings are also of clinical significance. Finally, hypothesis testing allows for four possible outcomes, two of which are errors that can lead to erroneous adoption of certain hypotheses: 1. The null hypothesis is rejected when, in fact, it is false. 2. The null hypothesis is rejected when, in fact, it is true (type I or alpha error). 3. The null hypothesis is conceded when, in fact, it is true. 4. The null hypothesis is conceded when, in fact, it is false (type II or beta error). The implications of these errors, their relation to sample size, the interpretation of negative trials, and strategies related to the planning of clinical trials will be explored in a future article in this journal.

  2. Competency to stand trial among female inpatients.

    Science.gov (United States)

    Kois, Lauren; Pearson, Jessica; Chauhan, Preeti; Goni, Margaret; Saraydarian, Lisa

    2013-08-01

    Competency to stand trial evaluations are conducted by forensic mental health professionals to opine whether defendants possess the mental abilities to understand, appreciate, and reason in regard to their court proceedings. The majority of research on competency to stand trial evaluations has focused on males, with research on female defendants being relatively underexplored. Even less is known of diverse female samples referred for competency evaluation. In the current study, we sought to examine whether characteristics associated with competency among predominantly male samples translate to a racially, ethnically, and culturally diverse group of female defendants (N = 288, 85% non-White). Chi-square analyses revealed significant relationships between findings of incompetence and defendants' diagnosis of a psychotic disorder, active psychotic symptoms, medication noncompliance, nonparticipation in the evaluation, and nonfelony charges. Logistic regression analysis indicated that defendants who experienced active psychotic symptoms, did not participate in their evaluations, and were not compliant with their medication were most likely to be found incompetent. Notably, neither minority status nor age was a significant characteristic in predicting incompetence. These findings in particular differ from much of the literature and highlight the need to examine competency within a cross-cultural framework, as characteristics associated with competency opinions do not necessarily translate across demographic groups.

  3. Citation Sentiment Analysis in Clinical Trial Papers

    Science.gov (United States)

    Xu, Jun; Zhang, Yaoyun; Wu, Yonghui; Wang, Jingqi; Dong, Xiao; Xu, Hua

    2015-01-01

    In scientific writing, positive credits and negative criticisms can often be seen in the text mentioning the cited papers, providing useful information about whether a study can be reproduced or not. In this study, we focus on citation sentiment analysis, which aims to determine the sentiment polarity that the citation context carries towards the cited paper. A citation sentiment corpus was annotated first on clinical trial papers. The effectiveness of n-gram and sentiment lexicon features, and problem-specified structure features for citation sentiment analysis were then examined using the annotated corpus. The combined features from the word n-grams, the sentiment lexicons and the structure information achieved the highest Micro F-score of 0.860 and Macro-F score of 0.719, indicating that it is feasible to use machine learning methods for citation sentiment analysis in biomedical publications. A comprehensive comparison between citation sentiment analysis of clinical trial papers and other general domains were conducted, which additionally highlights the unique challenges within this domain. PMID:26958274

  4. Diagnostic randomized controlled trials: the final frontier.

    Science.gov (United States)

    Rodger, Marc; Ramsay, Tim; Fergusson, Dean

    2012-08-16

    Clinicians, patients, governments, third-party payers, and the public take for granted that diagnostic tests are accurate, safe and effective. However, we may be seriously misled if we are relying on robust study design to ensure accurate, safe, and effective diagnostic tests. Properly conducted, randomized controlled trials are the gold standard for assessing the effectiveness and safety of interventions, yet are rarely conducted in the assessment of diagnostic tests. Instead, diagnostic cohort studies are commonly performed to assess the characteristics of a diagnostic test including sensitivity and specificity. While diagnostic cohort studies can inform us about the relative accuracy of an experimental diagnostic intervention compared to a reference standard, they do not inform us about whether the differences in accuracy are clinically important, or the degree of clinical importance (in other words, the impact on patient outcomes). In this commentary we provide the advantages of the diagnostic randomized controlled trial and suggest a greater awareness and uptake in their conduct. Doing so will better ensure that patients are offered diagnostic procedures that will make a clinical difference.

  5. Citation Sentiment Analysis in Clinical Trial Papers.

    Science.gov (United States)

    Xu, Jun; Zhang, Yaoyun; Wu, Yonghui; Wang, Jingqi; Dong, Xiao; Xu, Hua

    2015-01-01

    In scientific writing, positive credits and negative criticisms can often be seen in the text mentioning the cited papers, providing useful information about whether a study can be reproduced or not. In this study, we focus on citation sentiment analysis, which aims to determine the sentiment polarity that the citation context carries towards the cited paper. A citation sentiment corpus was annotated first on clinical trial papers. The effectiveness of n-gram and sentiment lexicon features, and problem-specified structure features for citation sentiment analysis were then examined using the annotated corpus. The combined features from the word n-grams, the sentiment lexicons and the structure information achieved the highest Micro F-score of 0.860 and Macro-F score of 0.719, indicating that it is feasible to use machine learning methods for citation sentiment analysis in biomedical publications. A comprehensive comparison between citation sentiment analysis of clinical trial papers and other general domains were conducted, which additionally highlights the unique challenges within this domain.

  6. Clinical Trials in Branch Retinal Vein Occlusion

    Science.gov (United States)

    Panakanti, Tandava Krishnan; Chhablani, Jay

    2016-01-01

    Branch retinal vein occlusion (BRVO) is the second most common retinal vascular disorder. The management of macular edema has changed considerably over time. The laser is considered the gold standard treatment for over two decades. However, visual recovery with laser is usually slow and incomplete. The advent of intravitreal agents, specifically anti-vascular endothelial growth factors (VEGF) have heralded a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have reported optimal results with anti-VEGF agents (ranibizumab, bevacizumab, and aflibercept) compared to laser therapy or steroids. However, nearly 50% of the patients require repeat intravitreal anti-VEGF therapy up to 4 years after initiating therapy to sustain the visual gains. The adverse events (systemic and ocular) of these agents are minimal. Monotherapy with anti-VEGF agents have been found to provide better results than any combination with laser. This review article summarizes evidence from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special focus on anti-VEGF therapy. PMID:26957837

  7. Clinical trials in branch retinal vein occlusion

    Directory of Open Access Journals (Sweden)

    Tandava Krishnan Panakanti

    2016-01-01

    Full Text Available Branch retinal vein occlusion (BRVO is the second most common retinal vascular disorder. The management of macular edema has changed considerably over time. The laser is considered the gold standard treatment for over two decades. However, visual recovery with laser is usually slow and incomplete. The advent of intravitreal agents, specifically anti-vascular endothelial growth factors (VEGF have heralded a new era which promises rapid recovery of vision and quality of vision. Randomized clinical trials have reported optimal results with anti-VEGF agents (ranibizumab, bevacizumab, and aflibercept compared to laser therapy or steroids. However, nearly 50% of the patients require repeat intravitreal anti-VEGF therapy up to 4 years after initiating therapy to sustain the visual gains. The adverse events (systemic and ocular of these agents are minimal. Monotherapy with anti-VEGF agents have been found to provide better results than any combination with laser. This review article summarizes evidence from randomized controlled trials evaluating treatment options for the treatment of macular edema secondary to BRVO with a special focus on anti-VEGF therapy.

  8. Subgroup identification from randomized clinical trial data.

    Science.gov (United States)

    Foster, Jared C; Taylor, Jeremy M G; Ruberg, Stephen J

    2011-10-30

    We consider the problem of identifying a subgroup of patients who may have an enhanced treatment effect in a randomized clinical trial, and it is desirable that the subgroup be defined by a limited number of covariates. For this problem, the development of a standard, pre-determined strategy may help to avoid the well-known dangers of subgroup analysis. We present a method developed to find subgroups of enhanced treatment effect. This method, referred to as 'Virtual Twins', involves predicting response probabilities for treatment and control 'twins' for each subject. The difference in these probabilities is then used as the outcome in a classification or regression tree, which can potentially include any set of the covariates. We define a measure Q(Â) to be the difference between the treatment effect in estimated subgroup  and the marginal treatment effect. We present several methods developed to obtain an estimate of Q(Â), including estimation of Q(Â) using estimated probabilities in the original data, using estimated probabilities in newly simulated data, two cross-validation-based approaches, and a bootstrap-based bias-corrected approach. Results of a simulation study indicate that the Virtual Twins method noticeably outperforms logistic regression with forward selection when a true subgroup of enhanced treatment effect exists. Generally, large sample sizes or strong enhanced treatment effects are needed for subgroup estimation. As an illustration, we apply the proposed methods to data from a randomized clinical trial.

  9. The Home-Based Older People's Exercise (HOPE trial: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Forster Anne

    2011-06-01

    Full Text Available Abstract Background Frailty is common in older age, and is associated with important adverse health outcomes including increased risk of disability and admission to hospital or long-term care. Exercise interventions for frail older people have the potential to reduce the risk of these adverse outcomes by increasing muscle strength and improving mobility. Methods/Design The Home-Based Older People's Exercise (HOPE trial is a two arm, assessor blind pilot randomised controlled trial (RCT to assess the effectiveness of a 12 week exercise intervention (the HOPE programme designed to improve the mobility and functional abilities of frail older people living at home, compared with usual care. The primary outcome is the timed-up-and-go test (TUGT, measured at baseline and 14 weeks post-randomisation. Secondary outcomes include the Barthel Index of activities of daily living (ADL, EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D quality of life measure and the geriatric depression scale (GDS, measured at baseline and 14 weeks post-randomisation. We will record baseline frailty using the Edmonton Frail Scale (EFS, record falls and document muscle/joint pain. We will test the feasibility of collection of data to identify therapy resources required for delivery of the intervention. Discussion The HOPE trial will explore and evaluate a home-based exercise intervention for frail older people. Although previous RCTs have used operationalised, non-validated methods of measuring frailty, the HOPE trial is, to our knowledge, the first RCT of an exercise intervention for frail older people that includes a validated method of frailty assessment at baseline. Trial registration ISRCTN: ISRCTN57066881

  10. Field Trials of Health Interventions, 3rd edition

    OpenAIRE

    Smith, Peter G; Richard H. Morrow; David A Ross

    2015-01-01

    Before new interventions can be used in disease control programmes, it is essential that they are carefully evaluated in “field trials”, which may be complex and expensive undertakings. Descriptions of the detailed procedures and methods used in trials that have been conducted in the past have generally not been published. As a consequence, those planning such trials have few guidelines available and little access to previously accumulated knowledge. In this book the practical issues of trial...

  11. Specification of phase I of new drugs' clinical tolerance trials

    Institute of Scientific and Technical Information of China (English)

    LI Guo-xin

    2008-01-01

    Phase I of clinical trials is the first stage of clinical pharmacology and body safety evaluation, including body tolerance test and pharmacokinetics test. The aim is providing evidence for dosage regimen and be the cornerstone of the preliminary assessment of efficacy and safety of phase II of clinical trials. This text discussed the technique and requirement of phase I of new drugs' clinical tolerance trials.

  12. Gene therapy clinical trials worldwide 1989-2004-an overview.

    Science.gov (United States)

    Edelstein, Michael L; Abedi, Mohammad R; Wixon, Jo; Edelstein, Richard M

    2004-06-01

    In 1989, Rosenberg et al. performed the first human gene therapy trial when they used a retrovirus to introduce the gene coding for resistance to neomycin into human tumor-infiltrating lymphocytes before infusing them into five patients with advanced melanoma. This study demonstrated the feasibility of using retroviral gene transduction in humans and set the stage for further studies. Since then, over 900 clinical trials have been completed, are ongoing or have been approved worldwide. These trials have been designed to establish feasibility and safety, to demonstrate the reality of expression of therapeutic protein(s) in vivo by the genes transferred and, in some cases, to show therapeutic benefit. There is no single source of information that presents an overview of all the clinical trials undertaken worldwide. In 1997 we set up a database to bring all the information on clinical trials together as comprehensively and as globally as possible. The data were compiled and are regularly updated from official agency sources, the published literature, presentations at conferences and from information kindly provided by investigators or trial sponsors themselves. As of January 31, 2004, we have identified 918 trials in 24 countries. The USA accounts for two-thirds of these trials. Cancer is by far the most common disease indication, followed by inherited monogenic diseases, and cardiovascular diseases. Viral vectors have been the most frequently used vehicles for transferring genes into human cells, with retroviruses and adenoviruses representing the vast majority. Plasmid (naked) DNA and other non-viral vectors have been used in one-quarter of the trials. Over 100 distinct genes have been transferred. This article aims to provide a descriptive overview of the clinical trials that, to the best of our knowledge, have been or are being performed worldwide. Details of the data presented, including an interactive, searchable database that currently holds information on 918

  13. Recruitment and Retention of Patients into Emergency Medicine Clinical Trials

    OpenAIRE

    Cofield,Stacey; Conwit, Robin; Barsan, William; Quinn, James

    2010-01-01

    The emergency medicine and pre-hospital environments are unlike any other clinical environments and require special consideration to allow the successful implementation of clinical trials. This article reviews the specific issues involved in Emergency Medicine Clinical Trials (EMCT), and provides strategies from emergency medicine and non-emergency medicine trials to maximize recruitment and retention. While the evidence supporting some of these strategies is deficient, addressing recruitment...

  14. Challenges of randomized controlled trial design in plastic surgery.

    Science.gov (United States)

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  15. European randomized lung cancer screening trials: Post NLST.

    Science.gov (United States)

    Field, John K; van Klaveren, Rob; Pedersen, Jesper H; Pastorino, Ugo; Paci, Eugino; Becker, Nikolauss; Infante, Maurizo; Oudkerk, Matthijs; de Koning, Harry J

    2013-10-01

    Overview of the European randomized lung cancer CT screening trials (EUCT) is presented with regard to the implementation of CT screening in Europe; post NLST. All seven principal investigators completed a questionnaire on the epidemiological, radiological, and nodule management aspects of their trials at August 2010, which included 32,000 people, inclusion of UKLS pilot trial will reach 36,000. An interim analysis is planned, but the final mortality data testing is scheduled for 2015.

  16. Exploring Willingness to Participate in Clinical Trials by Ethnicity.

    Science.gov (United States)

    Pariera, Katrina L; Murphy, Sheila T; Meng, Jingbo; McLaughlin, Margaret L

    2016-09-07

    African-Americans and Hispanic-Americans are disproportionately affected by cancer, yet underrepresented in cancer clinical trials. Because of this, it is important to understand how attitudes and beliefs about clinical trials vary by ethnicity. A national, random sample of 860 adults was given an online survey about attitudes toward clinical trials. We examined willingness to participate in clinical trials, attitudes toward clinical trials, trust in doctors, attitudes toward alternative and complementary medicine, and preferred information channels. Results indicate that African-American and Hispanic-American participants have more negative attitudes about clinical trials, more distrust toward doctors, more interest in complementary and alternative medicine, and less willingness to participate in clinical trials than white/non-Hispanics, although specific factors affecting willingness to participate vary. The channels people turn to for information on clinical trials also varied by ethnicity. These results help explain the ethnic disparities in cancer clinical trial enrollment by highlighting some potential underlying causes and drawing attention to areas of importance to these groups.

  17. Clinical trials for stem cell transplantation: when are they needed?

    Science.gov (United States)

    Van Pham, Phuc

    2016-04-27

    In recent years, both stem cell research and the clinical application of these promising cells have increased rapidly. About 1000 clinical trials using stem cells have to date been performed globally. More importantly, more than 10 stem cell-based products have been approved in some countries. With the rapid growth of stem cell applications, some countries have used clinical trials as a tool to diminish the rate of clinical stem cell applications. However, the point at which stem cell clinical trials are essential remains unclear. This commentary discusses when stem cell clinical trials are essential for stem cell transplantation therapies.

  18. Gene therapy clinical trials worldwide to 2012 - an update.

    Science.gov (United States)

    Ginn, Samantha L; Alexander, Ian E; Edelstein, Michael L; Abedi, Mohammad R; Wixon, Jo

    2013-02-01

    To date, over 1800 gene therapy clinical trials have been completed, are ongoing or have been approved worldwide. Our database brings together global information on gene therapy clinical trials from official agency sources, published literature, conference presentations and posters kindly provided to us by individual investigators or trial sponsors. This review presents our analysis of clinical trials that, to the best of our knowledge, have been or are being performed worldwide. As of our June 2012 update, we have entries on 1843 trials undertaken in 31 countries. We have analysed the geographical distribution of trials, the disease indications (or other reasons) for trials, the proportions to which different vector types are used, and which genes have been transferred. Details of the analyses presented, and our searchable database are available on The Journal of Gene Medicine Gene Therapy Clinical Trials Worldwide website at: http://www.wiley.co.uk/genmed/clinical. We also provide an overview of the progress being made in clinical trials of gene therapy approaches around the world and discuss the prospects for the future.

  19. Trial order and retention interval in human predictive judgment.

    Science.gov (United States)

    Stout, Steven C; Amundson, Jeffrey C; Miller, Ralph R

    2005-12-01

    The influences of order of trial type and retention interval on human predictive judgments were assessed for a cue that was reinforced on half of its training presentations. Subjects observed 10 cue-outcome presentations (i.e., reinforced trials) and 10 cue-alone presentations (i.e., nonreinforced trials) in one of three different orders: all nonreinforced trials followed by all reinforced trials(latent inhibition), reinforced and nonreinforced trials interspersed (partial reinforcement), or al lreinforced trials followed by all nonreinforced trials (extinction). Ratings were based mainly on the most recent event type (i.e., a recency effect) when the test occurred immediately after training but were based mainly on initial event types (i.e., a primacy effect) when the test occurred after a 48-h delay. The subjects tested both immediately and with a long retention interval did not exhibit this shift to primacy (i.e., the recency effect persisted). These results demonstrate noncatastrophic forgetting and the flexible use of trial order information in predictive judgments.

  20. Adult cancer clinical trials that fail to complete: an epidemic?

    Science.gov (United States)

    Stensland, Kristian D; McBride, Russell B; Latif, Asma; Wisnivesky, Juan; Hendricks, Ryan; Roper, Nitin; Boffetta, Paolo; Hall, Simon J; Oh, William K; Galsky, Matthew D

    2014-09-01

    The number and diversity of cancer therapeutics in the pipeline has increased over the past decade due to an enhanced understanding of cancer biology and the identification of novel therapeutic targets. At the same time, the cost of bringing new drugs to market and the regulatory burdens associated with clinical drug development have progressively increased. The finite number of eligible patients and limited financial resources available to evaluate promising new therapeutics represent rate-limiting factors in the effort to translate preclinical discoveries into the next generation of standard therapeutic approaches. Optimal use of resources requires understanding and ultimately addressing inefficiencies in the cancer clinical trials system. Prior analyses have demonstrated that a large proportion of trials initiated by the National Cancer Institute (NCI) Cooperative Group system are never completed. While NCI Cooperative Group trials are important, they represent only a small proportion of all cancer clinical trials performed. Herein, we explore the problem of cancer clinical trials that fail to complete within the broader cancer clinical trials enterprise. Among 7776 phase II-III adult cancer clinical trials initiated between 2005-2011, we found a seven-year cumulative incidence of failure to complete of approximately 20% (95% confidence interval = 18% to 22%). Nearly 48000 patients were enrolled in trials that failed to complete. These trials likely contribute little to the scientific knowledge base, divert resources and patients from answering other critical questions, and represent a barrier to progress.

  1. On Trials by Deities%神判考析

    Institute of Scientific and Technical Information of China (English)

    徐晓光

    2012-01-01

    神判作为一种法文化现象,在世界很多民族中都曾普遍存在过。从神判工具性角度做新的分类,将自远古开始的神兽判归为“触角”神判;将殷商的甲骨占卜神判定为“纹理”神判;将少数民族中的涝沸判、铁火判划为“烫伤”神判等,同时对各种神判现象进行文化分析。%As a phenomenon of legal culture, trials by deities are commonly practiced by many nations of the world. Based on the uses of tools in the process, the present study is to make new classifications of such trials, treating the trials with divine animals in ancient time as Antennae Trials, the trials with tortoise shells in the Shang Dynasty as Texture Trials and the trials in the means of boiling water or burning irons of minorities as Burns Trials. Cultural analyses are made to varied trial phenomena.

  2. [Effect of the GCP Directive on academic drug trials

    DEFF Research Database (Denmark)

    Berendt, L.; Hakansson, C.; Bach, K.F.;

    2008-01-01

    Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials. However, a steady decline...... was observed over the entire period. Presumably, the introduction of GCP did not entail a decline because of the presence of GCP units at university hospitals. Thus, researchers can conduct clinical drug trials under the same regulations as drug companies Udgivelsesdato: 2008/8/11...

  3. Placebos used in clinical trials for Chinese herbal medicine.

    Science.gov (United States)

    Qi, Guan D; We, Ding A; Chung, Leung P; Fai, Cheng K

    2008-06-01

    One of the important components in randomized Controlled Trial (RCT) is blinding. The gold standard of clinical trials is to achieve a double blind design. However, only a small number of randomized controlled trials in traditional Chinese medicine have been reported, most of them are of poor quality in methodology including placebo preparation and verification. The purpose of the article is to review the validity of placebo used in blinded clinical trials for Chinese herbal medicine (CHM) in recent years and related patents. We searched the Wanfang Database (total of 827 Chinese journals of medicine and/or pharmacy, from 1999 to 2005) and 598 full-length articles related to placebo clinical trials were found. 77 placebo blinded clinical trials for Chinese medicine were extracted by manual search from the 598 articles. After reviewing the 77 full-length articles, we found that nearly half of the clinical trials did not pay attention to the physical quality of the testing drug and placebo and whether they were of comparable physical quality. The rest provided very limited placebo information so that blinding assurance could not be assumed. Only 2 articles (2.6%) specifically validated the comparability between the testing drug and the placebo. Researchers in Chinese medicine commonly ignored the quality of the placebo in comparison to the test drug. This may be causing bias in the clinical trials. Quality specifications and evaluation of the placebo should deserve special attention to reduce bias in randomized controlled trials in TCM study.

  4. New generation of breast cancer clinical trials implementing molecular profiling

    Institute of Scientific and Technical Information of China (English)

    Dimitrios Zardavas; Martine Piccart-Gebhart

    2016-01-01

    The implementation of molecular profiling technologies in oncology deepens our knowledge for the molecular landscapes of cancer diagnoses, identifying aberrations that could be linked with specific therapeutic vulnerabilities. In particular, there is an increasing list of molecularly targeted anticancer agents undergoing clinical development that aim to block specific molecular aberrations. This leads to a paradigm shift, with an increasing list of specific aberrations dictating the treatment of patients with cancer. This paradigm shift impacts the field of clinical trials, since the classical approach of having clinico-pathological disease characteristics dictating the patients' enrolment in oncology trials shifts towards the implementation of molecular profiling as pre-screening step. In order to facilitate the successful clinical development of these new anticancer drugs within specific molecular niches of cancer diagnoses, there have been developed new, innovative trial designs that could be classified as follows: i) longitudinal cohort studies that implement (or not) "nested" downstream trials, 2) studies that assess the clinical utility of molecular profiling, 3) "master" protocol trials, iv) "basket" trials, v) trials following an adaptive design. In the present article, we review these innovative study designs, providing representative examples from each category and we discuss the challenges that still need to be addressed in this era of new generation oncology trials implementing molecular profiling. Emphasis is put on the field of breast cancer clinical trials.

  5. Phase 0 Trials: Expediting the Development of Chemoprevention Agents

    OpenAIRE

    Kummar, Shivaani; Doroshow, James H.

    2011-01-01

    Phase 0 trials are first-in-human clinical trials performed under the Exploratory IND [investigational new drug] Guidance of the US Food and Drug Administration. Unlike traditional phase I trials, these studies have no therapeutic or diagnostic intent but instead aim to provide only pharmacokinetic and/or pharmacodynamic data to inform the next step in developing an agent. We discuss the role that such trials, including one reported by Reid et al. (beginning on page XXX in this issue of the j...

  6. Open-access clinical trial registries: the Italian scenario

    Directory of Open Access Journals (Sweden)

    Mosconi Paola

    2012-10-01

    Full Text Available Abstract Background Citizens, patients and their representatives are increasingly insisting on working with health professionals to organize and discuss research protocols. The International Committee of Medical Journal Editors recommended setting up a public clinical trial registry where anyone can find key information about a trial. Around the world, governments have, in fact, now begun to legislate mandatory disclosure of all clinical trials. The aims of the present survey were to assess the availability of clinical trial registries for Italian citizens and to examine the transparency of the data items reported. Methods The availability of open-access clinical trial registries was surveyed on a sample of 182 websites, including research institutes and centers of excellence (IRCCS-teaching hospitals, hospitals and associations. For each registry we downloaded a sample of two trials to assess the correspondence of the data items reported. Results from the Italian and international registries were compared. Results Fifteen percent of the sample had an open-access registry of clinical trials. Comparison of the data items available, in terms of completeness and transparency, from institutional and international registries indicated wide variability. Conclusions Italian citizens, patients and their associations have scant access to local registries of clinical trials, and international registries are generally more informative. On the European level, advocacy and lobby actions are needed among citizens and patients to boost the diffusion of open-access clinical trial registries without language barriers, thereby facilitating participation, access to information, and the coordination of clinical research.

  7. Phases I–III Clinical Trials Using Adult Stem Cells

    Directory of Open Access Journals (Sweden)

    Ricardo Sanz-Ruiz

    2010-01-01

    Full Text Available First randomized clinical trials have demonstrated that stem cell therapy can improve cardiac recovery after the acute phase of myocardial ischemia and in patients with chronic ischemic heart disease. Nevertheless, some trials have shown that conflicting results and uncertainties remain in the case of mechanisms of action and possible ways to improve clinical impact of stem cells in cardiac repair. In this paper we will examine the evidence available, analyze the main phase I and II randomized clinical trials and their limitations, discuss the key points in the design of future trials, and depict new directions of research in this fascinating field.

  8. Recruitment and Retention of Patients into Emergency Medicine Clinical Trials

    Science.gov (United States)

    Cofield, Stacey; Conwit, Robin; Barsan, William; Quinn, James

    2010-01-01

    The emergency medicine and pre-hospital environments are unlike any other clinical environments and require special consideration to allow the successful implementation of clinical trials. This article reviews the specific issues involved in Emergency Medicine Clinical Trials (EMCT), and provides strategies from emergency medicine and non-emergency medicine trials to maximize recruitment and retention. While the evidence supporting some of these strategies is deficient, addressing recruitment and retention issues with specific strategies will help researchers deal with these issues in their funding applications and in turn develop the necessary infrastructure to participate in emergency medicine clinical trials. PMID:21040112

  9. The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS trial, an investigator initiated trial

    Directory of Open Access Journals (Sweden)

    Ongolo-Zogo Pierre

    2011-06-01

    Full Text Available Abstract Conducting clinical trials in developing countries often presents significant ethical, organisational, cultural and infrastructural challenges to researchers, pharmaceutical companies, sponsors and regulatory bodies. Globally, these regions are under-represented in research, yet this population stands to gain more from research in these settings as the burdens on health are greater than those in developed resourceful countries. However, developing countries also offer an attractive setting for clinical trials because they often have larger treatment naive populations with higher incidence rates of disease and more advanced stages. These factors can present a reduction in costs and time required to recruit patients. So, balance needs to be found where research can be encouraged and supported in order to bring maximum public health benefits to these communities. The difficulties with such trials arise from problems with obtaining valid informed consent, ethical compensation mechanisms for extremely poor populations, poor health infrastructure and considerable socio-economic and cultural divides. Ethical concerns with trials in developing countries have received attention, even though many other non-ethical issues may arise. Local investigator initiated trials also face a variety of difficulties that have not been adequately reported in literature. This paper uses the example of the Cameroon Mobile Phone SMS trial to describe in detail, the specific difficulties encountered in an investigator-initiated trial in a developing country. It highlights administrative, ethical, financial and staff related issues, proposes solutions and gives a list of additional documentation to ease the organisational process.

  10. Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

    OpenAIRE

    Grant, Sean P.; Evan Mayo-Wilson; Melendez-Torres, G. J.; Paul Montgomery

    2013-01-01

    BACKGROUND: Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVE/DESIGN: We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. DATA SOURCES: (1) To identify reporting guidelines, we systematically searched multiple electronic databases and ...

  11. The Proportion of Fixed Interval Trials to Probe Trials Affects Acquisition of the Peak Procedure Fixed Interval Timing Task

    OpenAIRE

    2007-01-01

    A common procedure for studying the ability of animals to time is the peak procedure. With the peak procedure animals are first trained on a fixed interval schedule (i.e., 30 seconds). After the animals have been well trained on the fixed interval schedule, probe trials are introduced. On probe trials the stimulus is presented longer (i.e., 90 seconds) and the animal does not receive reinforcement for responding. When animals are first presented with probe trials responding remains flat follo...

  12. A pragmatic multi-centred randomised controlled trial of yoga for chronic low back pain: Trial protocol

    OpenAIRE

    Cox, Helen; Tilbrook, Helen; Aplin, John; Chuang, Ling-Hsiang; Hewitt, Catherine; Jayakody, Shalmini; Semlyen, Anna; Soares, Marta O; Torgerson, David; Trewhela, Alison; Watt, Ian; Worthy, Gill

    2010-01-01

    A systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a randomised controlled trial (RCT) to determine the effectiveness and cost-effectiveness of Yoga for chronic Low Back Pain, which is...

  13. Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme

    Directory of Open Access Journals (Sweden)

    Raftery James

    2011-05-01

    Full Text Available Abstract Background Previous research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios. Methods Data on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each trial's primary results was classified into six categories; 1 statistically significant in favour of the new treatment, 2 statistically significant in favour of the control treatment 3 true negative, 4 truly inconclusive, 5 inconclusive in favour of new treatment or 6 inconclusive in favour of control treatment. Trials were classified by comparing the 95% confidence interval for the difference in primary outcome to the difference specified in the sample size calculation. The results were compared with Djulbegovic's analysis of NCI trials. Results Data from 51 superiority trials were included, involving over 48,000 participants and a range of diseases and interventions. 85 primary comparisons were available because some trials had more than two randomised arms or had several primary outcomes. The new treatment had superior results (whether significant or not in 61% of the comparisons (52/85 95% CI 49.9% to 71.6%. The results were conclusive in 46% of the comparisons (19% statistically significant in favour of the new treatment, 5% statistically significant in favour of the control and 22% true negative. The results were classified as truly inconclusive (i.e. failed to answer the question asked for 24% of comparisons (20/85. HTA trials included fewer truly inconclusive and statistically significant results and more results rated as true negative than NCI trials. Conclusions The pattern of results in HTA trials is similar to that of the National Cancer Institute portfolio. Differences that

  14. The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial

    Directory of Open Access Journals (Sweden)

    2007-10-01

    Full Text Available Abstract Background Caesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years – about 20–25% in many developed countries. Rates in other parts of the world vary widely. A variety of surgical techniques for all elements of the caesarean section operation are in use. Many have not yet been rigorously evaluated in randomised controlled trials, and it is not known whether any are associated with better outcomes for women and babies. Because huge numbers of women undergo caesarean section, even small differences in post-operative morbidity rates between techniques could translate into improved health for substantial numbers of women, and significant cost savings. Design CORONIS is a multicentre, fractional, factorial randomised controlled trial and will be conducted in centres in Argentina, Ghana, India, Kenya, Pakistan and Sudan. Women are eligible if they are undergoing their first or second caesarean section through a transverse abdominal incision. Five comparisons will be carried out in one trial, using a 2 × 2 × 2 × 2 × 2 fractional factorial design. This design has rarely been used, but is appropriate for the evaluation of several procedures which will be used together in clinical practice. The interventions are: • Blunt versus sharp abdominal entry • Exteriorisation of the uterus for repair versus intra-abdominal repair • Single versus double layer closure of the uterus • Closure versus non-closure of the peritoneum (pelvic and parietal • Chromic catgut versus Polyglactin-910 for uterine repair The primary outcome is death or maternal infectious morbidity (one or more of the following: antibiotic use for maternal febrile morbidity during postnatal hospital stay, antibiotic use for endometritis, wound infection or peritonitis or further operative procedures; or blood transfusion. The sample size required is 15,000 women in total; at least 7,586 women

  15. DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    van de Wall Bryan JM

    2010-08-01

    Full Text Available Abstract Background Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. Methods/design The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management. Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used. The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. Discussion Considering the high incidence and the

  16. Individual nutrition therapy and exercise regime: A controlled trial of injured, vulnerable elderly (INTERACTIVE trial

    Directory of Open Access Journals (Sweden)

    Whitehead Craig

    2008-02-01

    Full Text Available Abstract Background Proximal femoral fractures are amongst the most devastating consequences of osteoporosis and injurious accidental falls with 25–35% of patients dying in the first year post-fracture. Effective rehabilitation strategies are evolving however, despite established associations between nutrition, mobility, strength and strength-related functional outcomes; there has been only one small study with older adults immediately following fragility fracture where a combination of both exercise and nutrition have been provided. The aim of the INTERACTIVE trial is to establish whether a six month, individualised exercise and nutrition program commencing within fourteen days of surgery for proximal femur fracture, results in clinically and statistically significant improvements in physical function, body composition and quality of life at an acceptable level of cost and resource use and without increasing the burden of caregivers. Methods and Design This randomised controlled trial will be performed across two sites, a 500 bed acute hospital in Adelaide, South Australia and a 250 bed acute hospital in Sydney, New South Wales. Four hundred and sixty community-dwelling older adults aged > 70 will be recruited after suffering a proximal femoral fracture and followed into the community over a 12-month period. Participants allocated to the intervention group will receive a six month individualised care plan combining resistance training and nutrition therapy commencing within 14 days post-surgery. Outcomes will be assessed by an individual masked to treatment allocation at six and 12 months. To determine differences between the groups at the primary end-point (six months, ANCOVA or logistic regression will be used with models adjusted according to potential confounders. Discussion The INTERACTIVE trial is among the first to combine nutrition and exercise therapy as an early intervention to address the serious consequence of rapid deconditioning

  17. ATLAS Canada lightpath data transfer trial

    CERN Document Server

    Kost, C J; Caron, B; Hong, W

    2003-01-01

    Emerging grids play a significant role in the computational, data, storage, and network requirements of high energy physics experiments coming online in the next few years. One such requirement, the bulk transfer of data over advanced high speed optical networks is necessary as such experiments are highly distributed with resources and participants from research laboratories and institutions spanning the globe. This trial at the iGrid 2002 conference attempts to stress the feasibility of high speed bulk data transfer over an end-to-end lightpath, a dedicated point-to-point optical link. Specifically, the objective was to transfer 1 TB of Monte Carlo data from TRIUMF in Vancouver, Canada, to CERN in Geneva, Switzerland. A rate equivalent to transferring a full CD of data every 8 s was achieved. (15 refs).

  18. Drug interactions in controlled clinical trials.

    Science.gov (United States)

    Gershon, S

    1982-12-01

    As much information as possible should be obtained in clinical trials to assess possible interactions between test drugs and concomitant medications prescribed for other medical indications. Side effect profiles were compared in patients taking buspirone, mean = 20 mg/day; diazepam, 20 mg/day; clorazepate, 23 mg/day; and placebo, with or without concomitant medications. Approximately 1,000 anxious patients were included in the analysis; 700 received buspirone. The use of a variety of common medications did not affect the side effect profile in the buspirone, clorazepate, and placebo groups, but did increase the incidence of side effects in the diazepam group. The increased incidence of sedation noted with diazepam and clorazepate, however, was not due to concomitant medication.

  19. Calculating Outsourcing Strategies and Trials of Strength

    DEFF Research Database (Denmark)

    Christensen, Mark; Skærbæk, Peter; Tryggestad, Kjell

    was termed ‘internal optimization’ to first increase efficiency and be followed by anticipated sequential tenders to test the free market against internal provision. This option implied a time perspective where outsourcing, if not economically feasible, would be postponed and subsequently tested...... demonstrates the power of projects and their use of accounting calculation. We study how the two options emerged and were valued differently by the supra-national outsourcing program and the local Defense projects over 22 years and how that valuation process involved accounting. Drawing on Actor-Network Theory...... we show how the two strategic options emerged and were pitted against each other in what Latour and Callon describe as ‘trials of strength’. The contribution of the paper is in four parts: 1. highlights how accounting inscriptions take part in formulating, evaluating and advancing different...

  20. News from the Library: Knovel trial period

    CERN Multimedia

    CERN Library

    2014-01-01

    Knovel is a Web-based database integrating technical information with analytical and search tools. It is specifically aimed at the engineering community, offering validated content derived from the most trusted sources.   Knovel combines the functionalities of an e-book platform and a search engine querying a plurality of online databases. These functionalities are complemented by analytical tools that permit the extraction and manipulation of data from e-book content. Knovelʼs tools - including its interactive tables and graphs - not only help users to find information hidden in complex graphs, equations and tables quickly, but also to analyse and manipulate data as easily as sorting a spreadsheet. Using either simple keywords or full Boolean queries, Knovel searches across different data sets to find the information engineers need, however deeply it may be buried. For more information please visit why.knovel.com and the corresponding Youtube channel. A trial period of Knovel for the whol...