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

    DEFF Research Database (Denmark)

    Fink Topsøe, Märte; Bergholt, Thomas; Ravn, Pernille;

    2016-01-01

    to benign hysterectomy is still missing. OBJECTIVE: To investigate the anti-hemorrhagic effect of prophylactic tranexamic acid in elective benign hysterectomy. STUDY DESIGN: A double-blinded randomized placebo-controlled trial was conducted at four Gynecological departments in Denmark from April 2013...... in 2004, 8% of all women in Denmark undergoing benign hysterectomy experienced a bleeding complication. Tranexamic acid is an anti-fibrinolytic agent that has shown to effectively reduce bleeding complications within other surgical and medical areas. However, knowledge on the drugs effect in relation...... to October 2014. A total of 332 women undergoing benign abdominal, laparoscopic or vaginal hysterectomy were included in the trial, and randomized to either 1 g of intravenous tranexamic acid or placebo at start of surgery. Chi-test and Student T-test statistical analyses were applied. RESULTS: The...

  4. Antifibrinolytics in liver surgery

    OpenAIRE

    Jalpa Makwana; Saloni Paranjape; Jyotsna Goswami

    2010-01-01

    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 indica...

  5. Oral nimodipine reduces prostaglandin and thromboxane production by arteries chronically exposed to a periarterial haematoma and the antifibrinolytic agent tranexamic acid.

    Science.gov (United States)

    Pickard, J D; Walker, V; Vile, J; Perry, S; Smythe, P J; Hunt, R

    1987-06-01

    The calcium antagonist nimodipine blocks the effects of many vasoconstrictors of cerebrovascular smooth muscle and may reduce the incidence of delayed cerebral ischaemia following subarachnoid haemorrhage though not necessarily by inhibiting the development of angiographic cerebral vasospasm. Post-haemorrhagic CSF contains abnormally large quantities of various eicosanoids that partly reflect enhanced production by cerebral arteries. Does nimodipine affect this process? The extra-arterial and intra-arterial production of PG6 keto-F1 alpha, PGE2, PGF2 alpha and TXB2 were measured in perfused common carotid arteries taken from rabbits in which the arteries had been ensheathed by blood clot in vivo for 7 days. All rabbits were given the antifibrinolytic agent tranexamic acid to retard resolution of the clot, and half were given oral nimodipine (2 mg/kg/day) for 10 days. Nimodipine significantly reduced the extra-arterial production of TXB2 during the third and fourth hours of perfusion and, less consistently, the production of PGF2 alpha, PGE2 and PG6 keto-F1 alpha. Lutrol, the solvent for nimodipine, had no such effect. PMID:3475405

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

    OpenAIRE

    WANG, Meng; Zheng, Xin-Feng; Jiang, Lei-Sheng

    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...

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

    Directory of Open Access Journals (Sweden)

    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.

  8. Antifibrinolytics in cardiac surgery

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    Achal Dhir

    2013-01-01

    Full Text Available Cardiac surgery exerts a significant strain on the blood bank services and is a model example in which a multi-modal blood-conservation strategy is recommended. Significant bleeding during cardiac surgery, enough to cause re-exploration and/or blood transfusion, increases morbidity and mortality. Hyper-fibrinolysis is one of the important contributors to increased bleeding. This knowledge has led to the use of anti-fibrinolytic agents especially in procedures performed under cardiopulmonary bypass. Nothing has been more controversial in recent times than the aprotinin controversy. Since the withdrawal of aprotinin from the world market, the choice of antifibrinolytic agents has been limited to lysine analogues either tranexamic acid (TA or epsilon amino caproic acid (EACA. While proponents of aprotinin still argue against its non-availability. Health Canada has approved its use, albeit under very strict regulations. Antifibrinolytic agents are not without side effects and act like double-edged swords, the stronger the anti-fibrinolytic activity, the more serious the side effects. Aprotinin is the strongest in reducing blood loss, blood transfusion, and possibly, return to the operating room after cardiac surgery. EACA is the least effective, while TA is somewhere in between. Additionally, aprotinin has been implicated in increased mortality and maximum side effects. TA has been shown to increase seizure activity, whereas, EACA seems to have the least side effects. Apparently, these agents do not differentiate between pathological and physiological fibrinolysis and prevent all forms of fibrinolysis leading to possible thrombotic side effects. It would seem prudent to select the right agent knowing its risk-benefit profile for a given patient, under the given circumstances.

  9. 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.

  10. Tranexamic Acid Diminishes Laser-Induced Melanogenesis

    OpenAIRE

    Kim, Myoung Shin; Bang, Seung Hyun; Kim, Jeong-Hwan; Shin, Hong-Ju; Choi, Jee-Ho; Chang, Sung Eun

    2015-01-01

    Background The treatment of post-inflammatory hyperpigmentation (PIH) remains challenging. Tranexamic acid, a well-known anti-fibrinolytic drug, has recently demonstrated a curative effect towards melasma and ultraviolet-induced PIH in Asian countries. However, the precise mechanism of its inhibitory effect on melanogenesis is not fully understood. Objective In order to clarify the inhibitory effect of tranexamic acid on PIH, we investigated its effects on mouse melanocytes (i.e., melan-a cel...

  11. 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

  12. Systematic review: tranexamic acid for upper gastrointestinal bleeding

    DEFF Research Database (Denmark)

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

    2008-01-01

    BACKGROUND: Tranexamic acid may reduce upper gastrointestinal bleeding and stabilize patients before endoscopic treatments. AIM: To review randomized trials on tranexamic acid for upper gastrointestinal bleeding. METHODS: Manual and electronic searches of The Cochrane Library, MEDLINE, EMBASE and...... were unclearly reported. Data from three of the included trials suggested that tranexamic acid did not significantly increase the risk of thromboembolic disease. CONCLUSIONS: The present review suggests that tranexamic acid may reduce all-cause mortality. However, because of limitations in the internal...

  13. Are antifibrinolytic drugs equivalent in reducing blood loss and transfusion in cardiac surgery? A meta-analysis of randomized head-to-head trials

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    Stokes Barrie J

    2005-07-01

    Full Text Available Abstract Background Aprotinin has been shown to be effective in reducing peri-operative blood loss and the need for re-operation due to continued bleeding in cardiac surgery. The lysine analogues tranexamic acid (TXA and epsilon aminocaproic acid (EACA are cheaper, but it is not known if they are as effective as aprotinin. Methods Studies were identified by searching electronic databases and bibliographies of published articles. Data from head-to-head trials were pooled using a conventional (Cochrane meta-analytic approach and a Bayesian approach which estimated the posterior probability of TXA and EACA being equivalent to aprotinin; we used as a non-inferiority boundary a 20% increase in the rates of transfusion or re-operation because of bleeding. Results Peri-operative blood loss was significantly greater with TXA and EACA than with aprotinin: weighted mean differences were 106 mls (95% CI 37 to 227 mls and 185 mls (95% CI 134 to 235 mls respectively. The pooled relative risks (RR of receiving an allogeneic red blood cell (RBC transfusion with TXA and EACA, compared with aprotinin, were 1.08 (95% CI 0.88 to 1.32 and 1.14 (95% CI 0.84 to 1.55 respectively. The equivalent Bayesian posterior mean relative risks were 1.15 (95% Bayesian Credible Interval [BCI] 0.90 to 1.68 and 1.21 (95% BCI 0.79 to 1.82 respectively. For transfusion, using a 20% non-inferiority boundary, the posterior probabilities of TXA and EACA being non-inferior to aprotinin were 0.82 and 0.76 respectively. For re-operation the Cochrane RR for TXA vs. aprotinin was 0.98 (95% CI 0.51 to 1.88, compared with a posterior mean Bayesian RR of 0.63 (95% BCI 0.16 to 1.46. The posterior probability of TXA being non-inferior to aprotinin was 0.92, but this was sensitive to the inclusion of one small trial. Conclusion The available data are conflicting regarding the equivalence of lysine analogues and aprotinin in reducing peri-operative bleeding, transfusion and the need for re

  14. Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain: a prospective triple-blinded randomized controlled trial

    OpenAIRE

    Paphon Sa-ngasoongsong; Thanaphot Channoom; Viroj Kawinwonggowit; Patarawan Woratanarat; Pongsthorn Chanplakorn; Bussanee Wibulpolprasert; Siwadol Wongsak; Umaporn Udomsubpayakul; Supaporn Wechmongkolgorn; Nantaporn Lekpittaya

    2011-01-01

    A high-dose local tranexamic acid has been introduced in total knee arthroplasty for bleeding control. We are not sure about the systemic absorption and side effects. The aim of this study was to evaluate the effect of low dosage of intra-articular tranexamic acid injection combined with 2-hour clamp drain in minimally bleeding computer-assisted surgery total knee replacement (CAS-TKR). A prospective randomized controlled trial was conducted in a total of 48 patients underwent CAS-TKR. The pa...

  15. Tranexamic acid for upper gastrointestinal bleeding

    DEFF Research Database (Denmark)

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

    2014-01-01

    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 tranexamic acid and 71 of 850 in the control group died (RR 0.60, 95% CI 0.42 to 0.87; P value 0.007; I² = 0%). The analysis was...... review will be much more informative in a few years. Further examination of tranexamic acid would require inclusion of high-quality randomised controlled trials. Timing of randomisation is essential to avoid attrition bias and to limit the number of withdrawals. Future trials may use a pragmatic design...... and should include all participants with suspected bleeding or with endoscopically verified bleeding, as well as a tranexamic placebo arm and co-administration of pump inhibitors and endoscopic therapy. Assessment of outcome measures in such studies should be clearly defined. Endoscopic examination...

  16. Efficacy of tranexamic acid as compared to aprotinin in open heart surgery in children

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    Nagarajan Muthialu

    2015-01-01

    Full Text Available Background: Coagulopathy is a major issue in children undergoing high-risk pediatric cardiac surgery. Use of anti-fibrinolytics is well documented in adults, but recently there are questions raised about safety and effectiveness of their use on routine use. Tranexamic acid is a potent anti-fibrinolytic, but its role is not fully understood in children. This study aims to study the benefits tranexamic acid in controlling postoperative bleeding in pediatric cardiac surgical patients. Methods and Results: Fifty consecutive children who underwent cardiac surgery were randomized prospectively to receive either aprotinin (Group A; n = 24 or tranexamic acid (Group B; n = 26 from September 2009 to February 2010 were studied. Primary end points were early mortality, postoperative drainage, reoperation for bleeding and complications. Mean age and body weight was smaller in Group A (Age: 48.55 vs. 64.73 months; weight 10.75 vs. 14.80 kg respectively. Group A had more cyanotic heart disease than Group B (87.5% vs. 76.92%. Mean cardiopulmonary bypass time (144.33 vs. 84.34 min and aortic cross-clamp time (78.5 vs. 41.46 min were significantly higher in group A. While the blood and products usage was significantly higher in Group A, there was no difference in indexed postoperative drainage in first 4, 8 and 12 h and postoperative coagulation parameters. Mean C-reactive protein was less in Group A than B and renal dysfunction was seen more in Group A (25% vs. 7.6%. Mortality in Group A was 16.66% and 7.6% in Group B. Conclusion: Anti-fibrinolytics have a definitive role in high-risk children who undergo open-heart surgery. Tranexamic acid is as equally effective as aprotinin with no additional increase in morbidity or mortality. Ultramini Abstract: Coagulopathy has been a major issue in pediatric cardiac surgery, and anti-fibrinolytics have been used fairly regularly in various settings. This study aims to evaluate the efficacy of tranexamic acid as compared

  17. 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.

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

    OpenAIRE

    Tanmay Padhi; Swetalina Pradhan

    2015-01-01

    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...

  19. Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain: a prospective triple-blinded randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Paphon Sa-ngasoongsong

    2011-10-01

    Full Text Available A high-dose local tranexamic acid has been introduced in total knee arthroplasty for bleeding control. We are not sure about the systemic absorption and side effects. The aim of this study was to evaluate the effect of low dosage of intra-articular tranexamic acid injection combined with 2-hour clamp drain in minimally bleeding computer-assisted surgery total knee replacement (CAS-TKR. A prospective randomized controlled trial was conducted in a total of 48 patients underwent CAS-TKR. The patients were randomly assigned to receive either of a mixed intra-articular solution of tranexamic acid 250 mg with physiologic saline (TXA group, or physiologic saline (control group and then followed by clamp drain for 2 hours. Postoperative blood loss was measured by three different methods as drainage volume, total hemoglobin loss and calculated total blood loss. Transfusion requirement and postoperative complications were recorded. All patients were screened for deep vein thrombosis and the functional outcomes were evaluated at 6 months after surgery. The mean postoperative drainage volume, total hemoglobin loss and calculated total blood loss in TXA group were 308.8 mL, 2.1 g/dL and 206.3 mL compared to 529.0 mL, 3.0 g/dL and 385.1 mL in the control group (P=0.0003, 0.0005 and <0.0001 respectively. Allogenic blood transfusion was needed for one patient (4.2% in TXA group and for eight patients (33.3% in the control group. Postoperative knee scores were not significantly different between groups. No deep vein thrombosis, infection or wound complication was detected in both groups. In this study, low dose intra-articular tranexamic acid injection combined with 2-hour clamping drain was effective for reducing postoperative blood loss and transfusion requirement in CAS-TKR without significant difference in postoperative complications or functional outcomes.

  20. Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain: a prospective triple-blinded randomized controlled trial

    Science.gov (United States)

    Sa-ngasoongsong, Paphon; Channoom, Thanaphot; Kawinwonggowit, Viroj; Woratanarat, Patarawan; Chanplakorn, Pongsthorn; Wibulpolprasert, Bussanee; Wongsak, Siwadol; Udomsubpayakul, Umaporn; Wechmongkolgorn, Supaporn; Lekpittaya, Nantaporn

    2011-01-01

    A high-dose local tranexamic acid has been introduced in total knee arthroplasty for bleeding control. We are not sure about the systemic absorption and side effects. The aim of this study was to evaluate the effect of low dosage of intra-articular tranexamic acid injection combined with 2-hour clamp drain in minimally bleeding computer-assisted surgery total knee replacement (CAS-TKR). A prospective randomized controlled trial was conducted in a total of 48 patients underwent CAS-TKR. The patients were randomly assigned to receive either of a mixed intra-articular solution of tranexamic acid 250 mg with physiologic saline (TXA group), or physiologic saline (control group) and then followed by clamp drain for 2 hours. Postoperative blood loss was measured by three different methods as drainage volume, total hemoglobin loss and calculated total blood loss. Transfusion requirement and postoperative complications were recorded. All patients were screened for deep vein thrombosis and the functional outcomes were evaluated at 6 months after surgery. The mean postoperative drainage volume, total hemoglobin loss and calculated total blood loss in TXA group were 308.8 mL, 2.1 g/dL and 206.3 mL compared to 529.0 mL, 3.0 g/dL and 385.1 mL in the control group (P=0.0003, 0.0005 and <0.0001 respectively). Allogenic blood transfusion was needed for one patient (4.2%) in TXA group and for eight patients (33.3%) in the control group. Postoperative knee scores were not significantly different between groups. No deep vein thrombosis, infection or wound complication was detected in both groups. In this study, low dose intra-articular tranexamic acid injection combined with 2-hour clamping drain was effective for reducing postoperative blood loss and transfusion requirement in CAS-TKR without significant difference in postoperative complications or functional outcomes. PMID:22053253

  1. 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

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

    Science.gov (United States)

    Keyhani, Sohrab; Esmailiejah, Ali Akbar; Abbasian, Mohammad Reza; Safdari, Farshad

    2016-01-01

    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=0.031). Also, the rate of transfusion was significantly greater in the control group (P=0.013). However, IV and topical groups did not differ significantly in terms of measured variables. No patient experienced a thromboembolic event in our study. Conclusion: Tranexamic acid is a useful antifibrinolytic drug to reduce postoperative blood loss, Hb drop, and rate of blood transfusion in patients undergoing total knee arthroplasty. The route of tranexamic acid administration did not affect the efficacy and safety. PMID:26894222

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

    Directory of Open Access Journals (Sweden)

    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.

  4. Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial

    OpenAIRE

    Sa-ngasoongsong, Paphon; Wongsak, Siwadol; Chanplakorn, Pongsthorn; Woratanarat, Patarawan; Wechmongkolgorn, Supaporn; Wibulpolprasert, Bussanee; Mulpruek, Pornchai; Kawinwonggowit, Viroj

    2013-01-01

    Background Recently, a number of studies using intra-articular application of tranexamic acid (IA-TXA), with different dosage and techniques, successfully reduced postoperative blood loss in total knee replacement (TKR). However, best of our knowledge, the very low dose of IA-TXA with drain clamping technique in conventional TKR has not been yet studied. This study aimed to evaluate the effectiveness and dose-response effect of two low-dose IA-TXA regimens in conventional TKR on blood loss an...

  5. Tranexamic acid in surgical treatment of scoliosis in children: A case report

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    Rakić Goran

    2016-01-01

    Full Text Available Introduction. Children who are subjected to surgical treatment for scoliosis usually end up receiving a lot of blood transfusions since they tend to lose one or more blood volumes during the surgery. Tranexamic acid is an antifibrinolytic agent, increasingly used in children to reduce perioperative blood loss in various settings, including corrective surgery of scoliosis. Case Report. A 12-year-old girl, weighing 44 kg, was admitted to our hospital for scoliosis correction. She had congenital scoliosis caused by congenital malformation of vertebrae. The surgery was performed under balanced general anesthesia. Two central and one peripheral line were cannulated in case massive transfusion would be required. Invasive monitoring was used, as well as prevention of hypothermia. Since massive blood loss was expected, bolus of tranexamic acid had been administered prior to the surgery. Tranexamic acid was given continuously in an intravenous infusion during the surgery. Blood loss was only 10 ml/kg, and since the hemoglobin value was borderline (89 g/l during the surgery, the patient received 10 ml/kg of packed red blood cells. The child was hemodynamically stable throughout the surgery. After the completion of surgery, which lasted for 5 hours, the patient was extubated in the operating room. Postoperatively, the patient was transferred to the surgical ward. Hemoglobin values were stable and there was no need for additional blood replacement. Conclusion. Extensive blood loss is common in pediatric scoliosis correction surgery, transfusion being unavoidable in the majority of cases. In our patient, tranexamic acid proved safe and effective in reducing peri-operative blood loss and transfusion requirement.

  6. Topical tranexamic acid as a promising treatment for melasma

    OpenAIRE

    Bahareh Ebrahimi; Farahnaz Fatemi Naeini

    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...

  7. Blood Loss and Transfusion After Topical Tranexamic Acid Administration in Primary Total Knee Arthroplasty.

    Science.gov (United States)

    Wang, Hao; Shen, Bin; Zeng, Yi

    2015-11-01

    There has been much debate and controversy about the safety and efficacy of the topical use of tranexamic acid in primary total knee arthroplasty (TKA). The purpose of this study was to perform a meta-analysis to evaluate whether there is less blood loss and lower rates of transfusion after topical tranexamic acid administration in primary TKA. A systematic review of the electronic databases PubMed, CENTRAL, Web of Science, and Embase was undertaken. All randomized, controlled trials and prospective cohort studies evaluating the effectiveness of topical tranexamic acid during primary TKA were included. The focus of the analysis was on the outcomes of blood loss results, transfusion rate, and thromboembolic complications. Subgroup analysis was performed when possible. Of 387 studies identified, 16 comprising 1421 patients (1481 knees) were eligible for data extraction and meta-analysis. This study indicated that when compared with the control group, topical application of tranexamic acid significantly reduced total drain output (mean difference, -227.20; 95% confidence interval, -347.11 to -107.30; Pdeep venous thrombosis or pulmonary embolism due to tranexamic acid administration. Topical tranexamic acid was effective for reducing postoperative blood loss and transfusion requirements without increasing the prevalence of thromboembolic complications. PMID:26558665

  8. Use of Tranexamic acid is a cost effective method in preventing blood loss during and after total knee replacement

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    Umer Chaudhry Muhammad

    2011-05-01

    Full Text Available Abstract Background & Purpose Allogenic blood transfusion in elective orthopaedic surgery is best avoided owing to its associated risks. Total knee replacement often requires blood transfusion, more so when bilateral surgery is performed. Many strategies are currently being employed to reduce the amount of peri-operative allogenic transfusions. Anti-fibrinolytic compounds such as aminocaproic acid and tranexamic acid have been used systemically in perioperative settings with promising results. This study aimed to evaluate the effectiveness of tranexamic acid in reducing allogenic blood transfusion in total knee replacement surgery. Methodology This was a retrospective cohort study conducted on patients undergoing total knee replacement during the time period November 2005 to November 2008. Study population was 99 patients, of which 70 underwent unilateral and 29 bilateral knee replacement. Forty-seven patients with 62 (49.5% knees (group-I had received tranexamic acid (by surgeon preference while the remaining fifty-two patients with 66 (51.5% knees (group-II had did not received any tranexamic acid either pre- or post-operatively. Results The mean drop in the post-operative haemoglobin concentration in Group-II for unilateral and bilateral cases was 1.79 gm/dl and 2.21 gm/dl, with a mean post-operative drainage of 1828 ml (unilateral and 2695 ml (bilateral. In comparison, the mean drop in the post-op haemoglobin in Group-I was 1.49 gm/dl (unilateral and 1.94 gm/dl (bilateral, with a mean drainage of 826 ml (unilateral and 1288 ml (bilateral (p-value Interpretation Tranexamic acid is effective in reducing post-operative drainage and requirement of blood transfusion after knee replacement.

  9. 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

  10. Use of antifibrinolytic mouthwash solution in anticoagulated oral surgery patients

    OpenAIRE

    Dimova, Cena; Evrosimovska, Biljana; Papakoca, Kiro; Georgiev, Zlatko; Angelovska, Bistra; Ristoska, Sonja

    2012-01-01

    Introduction:The ordinary treatment of anticoagulated patients includes the interruption of anticoagulant therapy for oral surgery interventions to prevent hemorrhage. However, this practice may logically increase the risk of a potentially life-threatening thromboembolism, so this issue is still controversial. The aim of the study was to evaluate the antifibrinolitic mouthwash solution (tranexamic acid) as a local haemostatic modality after oral surgery interventions. Methods:To realize the a...

  11. Topical Application of Tranexamic Acid Reduces Postoperative Bleeding in Open-Heart Surgery: Myth or Fact

    International Nuclear Information System (INIS)

    Objective: To determine the efficacy of topical application of Tranexamic acid in controlling postoperative bleeding in open-heart surgery. Study Design: Double blind randomized control trial. Place and Duration of Study: Departments of Cardiac Surgery and Intensive Care of Armed Forces Institute of Cardiology and National Institute of Heart Diseases (AFIC-NIHD), Rawalpindi, Pakistan, from May to October 2011. Methodology: A total of 100 consecutive adult patients fulfilling the inclusion criteria undergoing elective on-pump cardiac surgeries were randomly divided in groups A and B. A study solution that contained 2.5 g of Tranexamic acid in 250 ml normal saline in group-A and equal amount of normal saline (placebo) in group-B was poured in the pericardial cavity over the mediastinal tissues before sternal closure. Postoperative bleeding was measured in both groups for 24 hours in the cardiac surgical ICU. Efficacy of Topical Tranexamic Acid / Placebo was measured in terms of mean postoperative bleeding in ml. Kindly again include these lines which seem to have been omitted in the final proof. Results: There was significant difference in the mean postoperative bleeding within 24 hours among the two groups 340.1 ± 112.4 ml in Tranexamic acid group vs. 665 ± 187.28 ml in placebo group (p < 0.001). Conclusion: Patients who did not have topical Tranexamic acid before chest closure had a significantly higher postoperative bleeding. Topical Tranexamic acid application is an effective and economical way for controlling non-surgical bleeding in patients undergoing cardiac surgery with cardiopulmonary bypass. (author)

  12. Comparison of topical use of protamine and tranexamic acid in surgical patients requiring cardio-pulmonary bypass

    International Nuclear Information System (INIS)

    To determine the effectiveness of local protamine in reducing post-operative blood loss compared to local tranexamic acid. Study Design: Randomized controlled trial. Place and Duration of Study: Armed Forces Institute of Cardiology/National Institute of Heart Diseases Rawalpindi from January 2011 to September 2011. Patients and Methods: One hundred and twenty cardiac surgical patients were randomly divided into two equal groups, one receiving local protamine while the other group receiving local tranexamic acid before chest closure. The efficiency was measured as post-operative blood loss and requirement of blood and blood products in the post-surgical ICU. Results: Average blood loss in protamine group was significantly less (252.97 ml) compared to tranexamic acid group (680.67 ml). Number of patients requiring no post-operative blood transfusion was significantly higher in protamine group (76.7%) compared to tranexamic acid group (53.3%). Conclusion: Local protamine is more effective in reducing post-operative blood loss than local tranexamic acid. (author)

  13. 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.

  14. Adsorption of tranexamic acid on hydroxyapatite: Toward the development of biomaterials with local hemostatic activity.

    Science.gov (United States)

    Sarda, Stéphanie; Errassifi, Farid; Marsan, Olivier; Geffre, Anne; Trumel, Catherine; Drouet, Christophe

    2016-09-01

    This work proposes to combine tranexamic acid (TAX), a clinically used antifibrinolytic agent, and hydroxyapatite (HA), widely used in bone replacement, to produce a novel bioactive apatitic biomaterial with intrinsic hemostatic properties. The aim of this study was to investigate adsorptive behavior of the TAX molecule onto HA and to point out its release in near physiological conditions. No other phase was observed by X-ray diffraction or transmission electron microscopy, and no apparent change in crystal size was detected. The presence of TAX on the powders was lightly detected on Raman spectra after adsorption. The adsorption data could be fitted with a Langmuir-Freundlich equation, suggesting a strong interaction between adsorbed molecules and the formation of multilayers. The concentration of calcium and phosphate ions in solution remained low and stable during the adsorption process, thus ion exchange during the adsorption process could be ruled out. The release of TAX was fast during the first hours and was governed by a complex process that likely involved both diffusion and dissolution of HA. Preliminary aPTT (activated partial thromboplastin time) hemostasis tests offered promising results for the development of osteoconductive apatitic biomaterials with intrinsic hemostatic properties, whether for dental or orthopedic applications. PMID:27207032

  15. The effects of topically applied tranexamic acid on reduction of post-laminectomy hemorrhage

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    Saberi H

    2010-12-01

    Full Text Available "n Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Topically applied tranexamic acid has been shown to decrease the amount of blood loss associated with major spinal surgical procedures. The aim of this study was to evaluate the effects of locally applied tranexamic acid in epidural space on post-laminectomy blood loss."n"nMethods: One hundred patients who were scheduled to undergo laminectomy in Imam Khomeini Hospital in Tehran, Iran were enrolled in a clinical trial. Patients were divided into two groups of unilateral one level (n=50 and bilateral two level (n=50 laminectomy according to the extent of surgery. Each group was randomly allocated into two groups of tranexamic acid (n=25 and control (n=25. At the end of the operation, 250mg tranexamic acid, with volume of 5ml or 5ml of normal saline were poured on the site of surgery. The blood volume drained during first and second 24hr, and overall hemorrhage, plus the duration of post operative hospitalization were compared between the two groups."n"nResults: The bleeding volume in the 1st 24hr was significantly less in tranexamic acid than control group (p=0.001. The bleeding volume in the 2nd 24hr was significantly less in tranexamic acid than control group (p=0.001. The hospital stay was less in

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

    OpenAIRE

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

    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 locali...

  17. 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.

  18. 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).

  19. 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. PMID:27133035

  20. 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.

  1. Tranexamic Acid and Hyaluronate/Carboxymethylcellulose Create Cell Injury

    OpenAIRE

    Yıldız, Elif; Yılmaz, Bayram; Dilbaz, Serdar; Üstün, Yusuf; Kumru, Selahattin

    2014-01-01

    Background and Objectives: Postoperative pelvic adhesions are associated with chronic pelvic pain, dyspareunia, and infertility. The aim of this study was to evaluate the adhesion prevention effects of tranexamic acid (TA) and hyaluronate/carboxymethylcellulose (HA/CMC) barrier in the rat uterine horn models on the basis of macroscopic and microscopic adhesion scores and histopathological as well as biochemical parameters of inflammation. Methods: Twenty-one Wistar rats were randomly divided ...

  2. Secapin, a bee venom peptide, exhibits anti-fibrinolytic, anti-elastolytic, and anti-microbial activities.

    Science.gov (United States)

    Lee, Kwang Sik; Kim, Bo Yeon; Yoon, Hyung Joo; Choi, Yong Soo; Jin, Byung Rae

    2016-10-01

    Bee venom contains a variety of peptide constituents that have various biological, toxicological, and pharmacological actions. However, the biological actions of secapin, a venom peptide in bee venom, remain largely unknown. Here, we provide the evidence that Asiatic honeybee (Apis cerana) secapin (AcSecapin-1) exhibits anti-fibrinolytic, anti-elastolytic, and anti-microbial activities. The recombinant mature AcSecapin-1 peptide was expressed in baculovirus-infected insect cells. AcSecapin-1 functions as a serine protease inhibitor-like peptide that has inhibitory effects against plasmin, elastases, microbial serine proteases, trypsin, and chymotrypsin. Consistent with these functions, AcSecapin-1 inhibited the plasmin-mediated degradation of fibrin to fibrin degradation products, thus indicating the role of AcSecapin-1 as an anti-fibrinolytic agent. AcSecapin-1 also inhibited both human neutrophil and porcine pancreatic elastases. Furthermore, AcSecapin-1 bound to bacterial and fungal surfaces and exhibited anti-microbial activity against fungi and gram-positive and gram-negative bacteria. Taken together, our data demonstrated that the bee venom peptide secapin has multifunctional roles as an anti-fibrinolytic agent during fibrinolysis and an anti-microbial agent in the innate immune response. PMID:27208884

  3. DOES TRANEXAMIC ACID REDUCE BLOOD LOSS IN OFF-PUMP CORONARY ARTERY BYPASS?

    OpenAIRE

    A. Mehr-Aein; M. Sadeghi M. Madani-Civi

    2006-01-01

    Tranexamic acid is now used on a routine basis for on-pump coronary artery bypass grafting (CABG). We assessed the hemostatic effects of tranexamic acid to decrease bleeding tendency and transfusion requirements in patients undergoing off-pump coronary artery bypass surgery (OPCAB). A total of 66 patients were enrolled to elective OPCAB in a double-blind, prospective randomized study. Of these, 33 patients received tranexamic acid (15 mg/kg before the infusion of heparin and 15 mg/kg after pr...

  4. Use of tranexamic acid for skin whitening and melasma therapy: A product review

    OpenAIRE

    Halimi Syafiqah Nadiah; Masood Hannah; Kah Seng Lee; Suhaidah Mohd Jofrry; Long Chiau Ming

    2016-01-01

    Purpose: The aim of this study is to assess the usage of tranexamic acid as skin whitening and melasma therapy. Methodology: An electronic search on PubMed, MEDLINE and Cochrane Library with keywords “tranexamic acid,” “oral,” “systemic,” “whitening,” “lightening,” and “melasma” was carried out. The literatures are summarized in the evidence tables. Further search on PBAC, UK, NFSA, SMC, CEDAC, MIMS, and Micromedex was performed for listing reviews of tranexamic acid. Results: The data ...

  5. 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.

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

    Directory of Open Access Journals (Sweden)

    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.

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

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    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.

  8. Comparison effect of intravenous tranexamic acid and misoprostol for postpartum haemorrhage

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    Farnaz Sahhaf

    2014-01-01

    Full Text Available Background: Postpartum haemorrhage (PPH is the third-most common cause of maternal death in the United States and it is still the first prevalent cause of maternal death in developing countries. Active prevention of haemorrhage with an uterotonic or other new drugs leads to a decrease in postpartum vaginal haemorrhage. The aim of this study was to compare anti-haemorrhagic effect of Tranexamic acid (TXA and Misoprostol for PPH. Patients and Methods: In a double-blinded randomised control clinical trial, 200 women were included after Caesarean or natural vaginal delivery with abnormal PPH. They were divided into two equal intervention and control groups. Effect of intravenous TXA and Misoprostol for postpartum haemorrhage was examined. Results: The mean age of patients was 26.7 ± 6.5 years which ranged from 14 to 43 years. The sonographic gestational age in the group treated with TXA was 37.7 ± 3.4 weeks and it was 37.4 ± 3.3 weeks for the other group (P = 0.44. The haemorrhage in the TXA and Misoprostol groups was 1.2 ± 0.33 litres and 1.18 ± 0.47 litres, respectively (P = 0.79. The haemoglobin levels after 6-12 hours of labour, in TXA group was more than that of the Misoprostol group, but this difference was not statistically significant (P = 0.22 and P = 0.21, respectively. Conclusion: Regarding to the superior results in Misoprostol group in one hand and lack of significant differences between two groups in haemorrhage during labour, post-partum haemoglobin level and discharge haemoglobin level, we can state that Misoprostol has no specific preferences to TXA, but more studies with greater population are needed.

  9. Use of tranexamic acid in primary total knee replacement: effects on perioperative blood loss

    Directory of Open Access Journals (Sweden)

    Daniel Volquind

    2016-06-01

    Full Text Available ABSTRACT BACKGROUND AND OBJECTIVES: The use of tranexamic acid in primary total knee replacement surgeries has been the subject of constant study. The strategies to reduce bleeding are aimed at reducing the need for blood transfusion due to the risks involved. In this study we evaluated the use of tranexamic acid in reducing bleeding, need for blood transfusion, and prevalence of postoperative deep vein thrombosis in primary total knee replacement. METHOD: 62 patients undergoing primary total knee replacement were enrolled in the study, from June 2012 to May 2013, and randomized to receive a single dose of 2.5 g of intravenous tranexamic acid (Group TA or saline (Group GP, 5 min before opening the pneumatic tourniquet, respectively. Hemoglobin, hematocrit, and blood loss were recorded 24 h after surgery. Deep vein thrombosis was investigated during patient's hospitalization and 15 and 30 days after surgery in review visits. RESULTS: There was no demographic difference between groups. Group TA had 13.89% decreased hematocrit (p = 0.925 compared to placebo. Group TA had a decrease of 12.28% (p = 0.898 in hemoglobin compared to Group GP. Group TA had a mean decrease of 187.35 mL in blood loss (25.32% compared to group GP (p = 0.027. The number of blood transfusions was higher in Group GP (p = 0.078. Thromboembolic events were not seen in this study. CONCLUSION: Tranexamic acid reduced postoperative bleeding without promoting thromboembolic events.

  10. Derivatization/chromophore introduction of tranexamic acid and its HPLC determination in pharmaceutical formulations

    Directory of Open Access Journals (Sweden)

    M. Ashfaq

    2015-04-01

    Full Text Available A viable cost-effective and isocratic approach employing C-18 column (250 mm × 4.6 mm, 5 μm based HPLC has been utilized to separate and estimate the drug, tranexamic acid in pharmaceutical formulations. Tranexamic acid contains no π-electrons to act as fluorophore or chromophore hence pre-column derivatization was performed with benzene sulfonyl chloride in aqueous medium at room temperature. The derivatized drug was then estimated using C-18 column by exploiting a 25:75 (v/v solvent mixture of acetonitrile and 0.1 M ammonium acetate (pH 5.0 as the mobile phase. The flow rate of mobile phase was 1 mL/min and detection was performed at a wavelength of 232 nm using UV detector. Retention time of tranexamic acid was 4.42 min. The method followed linear regression equation in the concentration range of 1–100 μg/mL with co-efficient of determination equal to 0.9994. The limit of detection and limit of quantitation were 0.3 and 1 μg/mL, respectively. The relative standard deviation and recovery ranges for tranexamic acid were found to be 0.11–2.47% and 97.60–103.25%, respectively. The suggested method is very sensitive and may have the potential to be used for tranexamic acid detection in medicinal formulations.

  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. 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.

  13. Suspected Transfusion Related Acute Lung Injury Improving following Administration of Tranexamic Acid: A Case Report

    OpenAIRE

    Stan Ryniak; Piotr Harbut; Anders Östlund; Andrzej Mysiak; Jan G. Jakobsson

    2014-01-01

    A 16-year-old woman with craniofacial injury developed severe acute respiratory failure under the primary reconstructive surgical procedure requiring several units of blood and plasma. A transfusion related acute lung injury (TRALI) was suspected and supportive treatment was initiated. Because of the severity of symptoms, acute extracorporeal membrane oxygenation (ECMO) was planned. During preparation for ECMO, a single intravenous dose, 1 g of tranexamic acid, was administered and a remarkab...

  14. Refractory status epilepticus after inadvertent intrathecal injection of tranexamic acid treated by magnesium sulfate.

    Science.gov (United States)

    Hatch, D M; Atito-Narh, E; Herschmiller, E J; Olufolabi, A J; Owen, M D

    2016-05-01

    We present a case of accidental injection of tranexamic acid during spinal anesthesia for an elective cesarean delivery. Immediately following intrathecal injection of 2mL of solution, the patient complained of severe back pain, followed by muscle spasm and tetany. As there was no evidence of spinal block, the medications given were checked and a 'used' ampoule of tranexamic acid was found on the spinal tray. General anesthesia was induced but muscle spasm and tetany persisted despite administration of a non-depolarizing muscle relaxant. Hemodynamic instability, ventricular tachycardia, and status epilepticus developed, which were refractory to phenytoin, diazepam, and infusions of thiopental, midazolam and amiodarone. Magnesium sulfate was administered postoperatively in the intensive care unit, following which the frequency of seizures decreased, eventually stopping. Unfortunately, on postoperative day three the patient died from cardiopulmonary arrest after an oxygen supply failure that was not associated with the initial event. This report underlines the importance of double-checking medications before injection in order to avoid a drug error. As well, it suggests that magnesium sulfate may be useful in stopping seizures caused by the intrathecal injection of tranexamic acid. PMID:26775897

  15. Bronchoscopic intratumoral injection of tranexamic acid to prevent excessive bleeding during multiple forceps biopsies of lesions with a high risk of bleeding: a prospective case series

    International Nuclear Information System (INIS)

    Significant bleeding may occur following endobronchial forceps biopsy or brushing of necrotic or hypervascular tumors in the airways. In some cases, methods such as endobronchial instillation of iced saline lavage and epinephrine may fail to control bleeding. The present study evaluated the efficacy and safety of a new bronchoscopic technique using intratumoral injection of tranexamic acid (IIT) for control of bleeding during forceps biopsy in patients with endobronchial tumors with a high risk of bleeding. The study was a prospective case series carried out in a single center. Bronchoscopic IIT was performed in those patients who had endoscopically visible tumoral lesions with persistent active bleeding following the first attempt at bronchoscopic sampling. Tranexamic acid (TEA) was injected through a 22-gauge Wang cytology needle into the lesion in nominal doses of 250–500 mg. After 2–3 minutes, multiple forceps biopsy specimens were obtained from the lesion. Of the 57 consecutive patients included in the study, 20 patients (35.1%) underwent bronchoscopic IIT. The first attempt in 18 patients was endobronchial forceps biopsy (EBB), and because of a high risk of bleeding, the first attempt for the remaining two patients, who were on continuous dual antiplatelet therapy (aspirin and clopidogrel), employed endobronchial needle aspiration (EBNA) as a precautionary measure. Following IIT, subsequent specimens were obtained using EBB in all patients. Multiple forceps biopsy specimens (3–10) were obtained from the lesions (8 necrotic and 12 hypervascular) without incurring active bleeding. The following histopathologic diagnoses were made: squamous cell carcinoma (n = 14), adenocarcinoma (n = 2), small-cell lung cancer (n = 3), and malignant mesenchymal tumor (n = 1). No side effects of TEA were observed. Bronchoscopic IIT is a useful and safe technique for controlling significant bleeding from a forceps biopsy procedure and can be considered as a pre

  16. Fibrinolytic Inhibitors in Off-pump Coronary Surgery: A Prospective, Randomized, Double-Blind TAP Study (Tranexamic Acid, Aprotinin, Placebo)

    Czech Academy of Sciences Publication Activity Database

    Vaněk, T.; Jareš, M.; Fajt, R.; Straka, Z.; Jirásek, K.; Kolesár, M.; Brůček, P.; Malý, Marek

    2005-01-01

    Roč. 28, č. 4 (2005), s. 563-568. ISSN 1010-7940 Source of funding: V - iné verejné zdroje Keywords : tranexamic acid * protinin * off-pump coronary artery bypass * hemostasis Subject RIV: BB - Applied Statistics, Operational Research Impact factor: 1.802, year: 2005

  17. 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

  18. 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

  19. Efficacy and Safety of Tranexamic Acid in Bilateral Total Knee Replacement: A Meta-Analysis and Systematic Review

    OpenAIRE

    He, Peiheng; Zhang, Ziji; Li, Yumin; Wang, Hua; Xu, Dongliang

    2015-01-01

    Background Tranexamic acid (TXA) has been well documented to reduce blood loss and transfusion requirements in patients undergoing unilateral total knee arthroplasty (TKA). However, the efficacy and safety of TXA in simultaneous bilateral TKA have not been clearly defined. The aim of our study was to systematically review the existing evidence regarding the role of TXA in patients undergoing simultaneous bilateral TKA. Material/Methods A systematic search of all studies published through June...

  20. 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; Holm, Gitte; Jacobsen, Tine W; Gebuhr, Peter

    2003-01-01

    . PATIENTS AND METHODS: 40 patients were randomized to tranexamic acid (10 mg/kg given as a bolus intravenous injection, followed by a continuous infusion of 1 mg/kg/hour for 10 hours) or placebo (20 mL saline given intravenously) 15 minutes before the incision. We recorded the peroperative and postoperative......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...... blood losses at removal of the drain 24 hours after the operation and the number of blood transfusions. RESULTS: Patients receiving tranexamic acid had a mean peroperative blood loss of 480 mL versus 622 mL in patients receiving placebo (p = 0.3), a postoperative blood loss of 334 mL versus 609 mL (p...

  1. Tranexamic acid for control of blood loss in bilateral total knee replacement in a single stage

    Directory of Open Access Journals (Sweden)

    Mandeep S Dhillon

    2011-01-01

    Full Text Available Background: Tranexamic acid (TEA reduces blood loss and red cell transfusions in patients undergoing unilateral total knee arthroplasty (TKA. However, there is not much literature regarding the use of TEA in patients undergoing bilateral TKA in a single stage and the protocols for administration of TEA in such patients are ill-defined. Materials and Methods: We carried out a case control study evaluating the effect of TEA on postoperative hemoglobin (Hb, total drain output, and number of blood units transfused in 52 patients undergoing bilateral TKA in a single stage, and compared it with 56 matched controls who did not receive TEA. Two doses of TEA were administered in doses of 10 mg / kg each (slow intravenous (IV infusion, with the first dose given just before tourniquet release of the first knee and the second dose three hours after the first one. Results: A statistically significant reduction in the total drain output and requirement of allogenic blood transfusion in cases who received TEA, as compared to the controls was observed. The postoperative Hb and Hb at the time of discharge were found to be lower in the control group, and this result was found to be statistically significant. Conclusion: TEA administered in patients undergoing single stage bilateral TKA helped reduce total blood loss and decreased allogenic blood transfusion requirements. This might be particularly relevant, where facilities such as autologous reinfusion might not be available.

  2. 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

  3. 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; Holm, Gitte; Jacobsen, Tine W; Gebuhr, Peter Henrik

    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...

  4. 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.

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

    Directory of Open Access Journals (Sweden)

    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

  6. 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

    OpenAIRE

    Paphon Sa-ngasoongsong; Pongsthorn Chanplakorn; Siwadol Wongsak; Krisorn Uthadorn; Tanapong Panpikoon; Paisan Jittorntam; Katcharin Aryurachai; Pantap Angchaisukisiri; Viroj Kawinwonggowit

    2015-01-01

    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 th...

  7. 氨甲环酸与抑肽酶对心脏手术血液保护的Meta分析%Effects of tranexamic acid and aprotinin on blood-conservation in heart surgery: a meta-analysis

    Institute of Scientific and Technical Information of China (English)

    叶博; 张国荣; 范勤; 曹晨; 魏国

    2011-01-01

    目的 系统评价氨甲环酸与抑肽酶在体外循环心脏手术中的血液保护效果.方法 检索Medline、PubMed、中国期刊全文数据库、中国生物医学文献数据库中氨甲环酸与抑肽酶对CPB心脏手术患者血液保护的随机对照研究文献,收集各研究中的血小板、凝血指标、血红蛋白、血细胞比容、术中出血量、术后24 h纵隔心包引流量、输血例数、术后并发症及术后近期死亡例数.计数资料采用优势比和95%可信区间表示,计量资料采用加权平均值和95%可信区间(CI)表示,所有计算和统计用RevMan 4.2.10软件完成,异质性检验采用χ2和I2完成.结果 符合标准的文献共16篇,3 393例患者.分析显示,与抑肽酶相比,氨甲环酸术后24 h纵隔心包引流量偏多(WMD=-65.28 CI:-103.92,-26.65 P=0.0009),但术后肾功能障碍患者例数明显较少(OR=1.36 CI:1.11,1.67 P=0.03),而血小板计数、凝血指标、血红蛋白值、术中出血量、成分输血例数均无显著差异(P>0.05).结论 在体外循环心脏手术中,氨甲环酸的血液保护效果比抑肽酶稍差,但其安全性能高,不易引起肾功能损害.%Objective To systematically evaluate the effect of tranexamic acid and aprotinin on blood conservation in open heart surgery with cardiopulmonary bypass.Methods A systematic overview and Meta - analysis were undertaken on all the randomized controlled trials of tranexamic acid and aprotinin in heart surgery from MEDLINE, PubMed, CNKI and CMB disk, with all the data as to platelets, coagulation indexes, hemoglobin ( Hb ), hematocrit ( Hct ), intraoperative hemorrhage volume, postoperative 24 h mediastinal pericardial drainage, cases of blood transfusion, postoperative complications and recent postoperative deaths.The weighted mean difference ( WMD ) with 95% confidence intervals ( CI ) for continuous data and odds ratio ( OR ) with 95% CI for dichotomous data were calculated.Statistical analysis was

  8. 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. PMID:23931279

  9. Evaluations of topical application of tranexamic acid on post-operative blood loss in off-pump coronary artery bypass surgery

    OpenAIRE

    Habibollah Hosseini; Ali Akbar Rahimianfar; Mohammad Hassan Abdollahi; Mohammad Hossein Moshtaghiyoon; Mahdi Haddadzadeh; Asefeh Fekri; Kazem Barzegar; Fatemeh Rahimianfar

    2014-01-01

    Objective: One of the major complications of cardiac surgery is the presence of post-operative bleeding. The aim of the present study was to investigate the topical application of tranexamic acid in the pericardial cavity on post-operative bleeding in off-pump coronary artery bypass graft (CABG) surgery. Materials and Methods: This study was on 71 patients who underwent off-pump CABG. The anesthesia and surgery methods were the same for all patients. Patients were assigned to two equal groups...

  10. 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

    Science.gov (United States)

    Sa-ngasoongsong, Paphon; Chanplakorn, Pongsthorn; Wongsak, Siwadol; Uthadorn, Krisorn; Panpikoon, Tanapong; Jittorntam, Paisan; Aryurachai, Katcharin; Angchaisukisiri, Pantap; Kawinwonggowit, Viroj

    2015-01-01

    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. PMID:26583092

  11. 氨甲环酸治疗黄褐斑的研究进展%Research progress of tranexamic acid in treatment of chloasma

    Institute of Scientific and Technical Information of China (English)

    李健和; 胡焰; 赵子影; 刘新义; 彭六保; 易利丹

    2013-01-01

    More and more clinical studies have shown that oral and (or) local administration of tranexamic acid as either monotherapy or adjunctive therapy is effective and safe for chloasma patients.The mechanism of its action is related with tyrosinase.It may interfere with the catalysis of tyrosinase by producing competition with tyrosine directly or may inhibit melanin synthesis in melanocytes by interfering with the interaction of melanocytes and keratinocytes for reducing the activity of tyrosinase through inhibition of the plasminogen/plasmin system.%越来越多的临床研究表明,口服和(或)局部给予氨甲环酸治疗黄褐斑疗效良好,不良反应小,可单独或联合其他药物或方法进行治疗.其作用机制与酪氨酸酶相关,可能直接与酪氨酸竞争,干扰酪氨酸酶对酪氨酸代谢的催化作用;也可能通过抑制纤溶酶原-纤溶酶系统干扰黑色素细胞和角化细胞的相互作用,降低酪氨酸酶的活性,从而抑制黑色素细胞黑色素的合成.

  12. Tranexamic Acid renovate skin texture in damaged skin%氨甲环酸对损伤后皮肤纹理的修复作用

    Institute of Scientific and Technical Information of China (English)

    袁超; 王学民; 谈益妹; 杨丽洁; 高延瑞

    2013-01-01

    Objective To determine whether or not Tranexamic Acid (TA) could renovate skin texture in damaged skin. Methods Two kinds of damaged skin models were set up and subjected to the repeated application of SLS (sodium lauryl sulfate) and irradiation of UVB (ultraviolet B). TA -induced changes in skin were detected by Visioscan 98. Results After 3, 7 and 14 days of application, TA can significantly increase all the Texture Parameters in SLS application, and only increase the Energy in UVB irradiation. TA could improve the SESM and SEW in two damaged skin models. Conclusion These experiments suggest that TA can significant improve skin texture in damaged skin.%目的:探讨氨甲环酸对化学损伤和物理损伤后皮肤纹理的修复作用.方法:5% SLS溶液反复涂抹形成化学损伤模型,3MED照射后形成物理损伤模型.两种不同皮肤损伤模型同时应用5%氨甲环酸水溶液进行涂抹.应用皮肤扫描仪对氨甲环酸组和自我修复组的皮肤纹理改变进行14天观察.结果:氨甲环酸可有效改善化学损伤后质地参数,物理损伤中仅可改善NRJ;氨甲环酸可改善两种损伤后的皮肤表面光滑度和细纹.结论:氨甲环酸在14天内对因化学或物理损伤引起的皮肤表面纹理有显著改善作用.

  13. 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 ...

  14. 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 ...

  15. Participating in Clinical Trials

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

  16. Significant improvement in crow's feet after treatment with Jet-M and a mixed solution of copper-GHK, oligo-hyaluronic acid, rhodiolar extract, tranexamic acid, and β-glucan (GHR formulation).

    Science.gov (United States)

    Byun, Sang-Young; Chae, Je-Byeong; Na, Jung-Im; Park, Kyoung-Chan

    2016-10-01

    Jet-M (Tav-Tech Ltd., Israel) is an instrument for skin resurfacing. When it sprays microdroplets of solution or shoots air on the skin, exfoliation and stretching of superficial layers can occur. Thus, it will increase percutaneous absorption of vitamins and other cosmetic agents. A cosmetic preparation containing copper-glycyl-L-histidyl-L-lysine, oligo-hyaluronic acid, rhodiolar extract, tranexamic acid, and β-glucan was used with Jet-M in one patient. Anesthesia was not administered and there was no pain during the treatment. A male aged 59 years was treated once a week for 12 weeks. In the clinical photographs, wrinkles around the treated eye were greatly decreased. Skin biopsies were taken from treated and untreated areas. Hematoxylin and eosin and Masson's trichrome staining showed increased collagen production in the upper dermis. On the other hand, collagen IV production was slightly increased. Fibrillin-1 and procollagen type 1 were greatly increased and tropoelastin was also increased. There was no adverse effect during and after treatment. PMID:27064823

  17. Participating in Clinical Trials

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    Full Text Available Home > Health topics A-Z > Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks ... centers across the country. The National Institutes of Health funds much of this basic research. Screening Trials ...

  18. Participating in Clinical Trials

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    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, ...

  19. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  20. 初次单侧骨水泥型全膝关节置换:氨甲环酸使用方式对失血量的影响%Primary unilateral cemented total knee arthroplasty:effect of tranexamic acid usage on blood loss

    Institute of Scientific and Technical Information of China (English)

    侯振扬; 苏长征; 庞涛; 吕东; 朱彪; 孙义玲; 李振; 柴星宇; 许正文

    2015-01-01

      结果与结论:B组及C组患者显性失血量和隐性失血量均较A组明显减少,差异有显著性意义(P0.05),在隐性失血量方面B组显著小于C组(P OBJECTIVE:To explore and discuss the effect of tranexamic acid and different usage methods on blood loss in the perioperative period of primary unilateral cemented total knee arthroplasty. METHODS:Sixty patients who were candidates for unilateral cemented total knee replacement in the Second Department of Joint Sports Medicine, Tengzhou Central People’s Hospital, from January 2013 to June 2014, were included in this study. Al patients were randomly divided into three groups. Group A (n=20):patients were injected with 100 mL normal saline through intravenous drip when the operation began, and then with 10 mL normal saline through intra-articular injection after skin closure. Group B (n=20):patients were injected with 10 mg/kg tranexamic acid which was dissolved in 100 mL normal saline when the operation began, and then with 10 mL normal saline through intra-articular injection after skin closure. Group C (n=20):patients were injected with 100 mL normal saline when the operation began, and then with 500 mg tranexamic acid dissolved in 10 mL normal saline through intra-articular injection after skin closure. The dominant blood loss, hidden blood loss, blood transfusion ratio and per capita of each group were compared. Clinical symptoms of pulmonary embolism and lower limb deep vein thrombosis were observed. Doppler ultrasound examine on lower extremity would be performed if necessary. RESULTS AND CONCLUSION:Dominant and hidden blood loss of patients from groups B and C were significantly lower than that of patients from group A (P0.05), the hidden blood loss in group B was significantly less than that in group C (P<0.05). The transfusion population and ratio of patients from groups B and C were significantly lower than that of patients from group A (P<0.05). In al three groups, no deep

  1. Participating in Clinical Trials

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    Full Text Available ... Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ... lifestyle changes, such as exercising more, getting more sleep, keeping mentally active, or eating nutritious foods, can ...

  2. Participating in Clinical Trials

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    Full Text Available ... Participating in Clinical Trials: About Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms ... with Your Doctor Taking Medicines The information in this topic was provided by the National Library of ...

  3. Participating in Clinical Trials

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    Full Text Available ... that could identify a disease in its early stages. Usually, trial participants must show signs of the ... Trials Clinical trials of drugs are usually described based on their phase. The U.S. Food and Drug ...

  4. Participating in Clinical Trials

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    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 ...

  5. Participating in Clinical Trials

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    Full Text Available ... Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose of ...

  6. Towards sustainable clinical trials

    OpenAIRE

    Group, Sustainable Trials Study

    2007-01-01

    Currently, few researchers think about the carbon footprint of their trial. The Sustainable Trials Study Group reports that clinical trials are carbon intensive and suggests ways to make them more efficient

  7. Participating in Clinical Trials

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    Full Text Available ... on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study that involves human subjects. The purpose ...

  8. Participating in Clinical Trials

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    Full Text Available ... 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 ...

  9. Clinical Trials in Vision Research

    Science.gov (United States)

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

  10. Clinical trials of homoeopathy.

    OpenAIRE

    Kleijnen, J.; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURE...

  11. Clinical Trial Results: A Clinical Trial Bazaar!

    OpenAIRE

    Fojo, Antonio Tito; Bates, Susan E.

    2014-01-01

    The Oncologist’s Clinical Trial Results section welcomes both positive and negative results in an effort to share information, speed discovery, and inform the field. Clinical Trial Results submissions have shown how succinctly the salient features of a submission can be presented, with more in-depth information to be found online.

  12. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... determine if the drug can be approved for use. A Phase I trial tests an experimental treatment ... the correct drug dosage. A Phase II trial uses more people (100 to 300). While the emphasis ...

  13. Participating in Clinical Trials

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    Full Text Available ... the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  14. Participating in Clinical Trials

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    Full Text Available ... Clinical Trials In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical ... researchers may gather information about experimental treatments, their risks, and how well they work compare existing therapies ...

  15. 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.

  16. 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.

  17. Participating in Clinical Trials

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    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is ...

  18. Participating in Clinical Trials

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    Full Text Available ... topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials About Clinical Trials A Research Study With Human Subjects A clinical trial is a research study ...

  19. AIDS Clinical Trials Group Network

    Science.gov (United States)

    ... Center Statistical and Data Management Center Glossaries Sites Clinical Trials About the Trial Process Trials Open to Enrollment Recent Study Results Access to Published Data Clinical Trials Resources Committees Executive Scientific Resource Community General Information ...

  20. 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.

  1. Overexpectation and Trial Massing

    OpenAIRE

    Sissons, Heather T.; Miller, Ralph R.

    2009-01-01

    Three experiments were conducted to examine the interaction of overexpectation treatment and trial massing using a Pavlovian fear conditioning procedure with rats. In first-order conditioning, Experiment 1 found the overexpectation effect (i.e., decreased conditioned responding to a cue after compound training when the elements were previously reinforced), the trial spacing effect (i.e., decreased responding to a cue when reinforced trials are massed), and a counteraction between overexpectat...

  2. Compliance in clinical trials.

    OpenAIRE

    Pullar, T; Kumar, S; Feely, M

    1989-01-01

    Compliance with treatment can be an important determinant of the outcome of clinical trials. To date there is no completely satisfactory method of measuring compliance and some of the most widely used methods are inadequate. The various methods of measuring compliance and how they have been applied to clinical trials are described, and improvements in the standard of the measurement and reporting of compliance in clinical trials are suggested.

  3. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ... 000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, they ...

  4. 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...

  5. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... can include imaging tests that produce pictures of what is inside the body laboratory tests that check samples of blood, urine, or other body tissues genetic tests that look for genes linked to some types of disease. Diagnostic Trials In diagnostic trials, researchers ...

  6. Participating in Clinical Trials

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    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... for more information Scientists usually do years of experiments in the laboratory and in animals before they even consider testing an experimental treatment ...

  7. 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...

  8. Miscanthus production field trials

    Energy Technology Data Exchange (ETDEWEB)

    Jones, B. [University Coll., Dublin (Ireland)

    1993-12-31

    Under the E.C. Joule program in 1989, a European network started on 18 sites a replicated production trial of an asian plant to produce biomass. The trials show that it is possible to successfully establish a Miscanthus crop under a wide range of climatic and edaphic conditions in Europe. Tests and results are presented. (TEC).

  9. 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 ...

  10. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P; Christensen, I; Denis, L

    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...

  11. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... In This Topic About Clinical Trials Risks and Benefits Terms to Know Finding a Clinical Trial Informed ... years of experiments in the laboratory and in animals before they even ... this early research occurs at universities and medical centers across the ...

  12. Participating in Clinical Trials

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    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... IV trial for drugs or devices takes place after the U.S. Food and Drug Administration approves their ...

  13. CLINICAL TRIALS.GOV

    Science.gov (United States)

    ClinicalTrials.gov 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 and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medi...

  14. 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 ...

  15. Participating in Clinical Trials

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    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 ...

  16. Participating in Clinical Trials

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    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, ...

  17. Participating in Clinical Trials

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    Full Text Available ... radiotherapy. Click for more information Scientists usually do years of experiments in the laboratory and in animals ... term side effects. This phase can last several years. A Phase III trial gathers more information about ...

  18. Participating in Clinical Trials

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    Full Text Available ... Drug Administration typically requires Phase 1, 2 and 3 trials to be conducted to determine if the ... subjects usually ranges from several hundred to about 3,000 people. If the U.S. Food and Drug ...

  19. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

    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 eac...

  20. Clinical Trial Basics

    Science.gov (United States)

    ... Human Services Search the NIH Website NIH Employee Intranet Staff Directory En Español Site Menu Home Health ... am thinking about participating? Xsandra/iStock Risks and benefits Clinical trials involve risks, just as routine medical ...

  1. Participating in Clinical Trials

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    Full Text Available ... was provided by the National Library of Medicine Topic last reviewed: December 2013 For an enhanced version of this page please turn Javascript on. Participating in Clinical Trials ...

  2. Participating in Clinical Trials

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    Full Text Available ... ways of finding a disease before symptoms occur. These methods, often called screening tests, can include imaging ... getting a disease or a specific medical problem. These trials find out if lifestyle changes, such as ...

  3. Participating in Clinical Trials

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    Full Text Available ... Researchers may study the role of caregivers, support groups, and various types of social interventions. Supportive care ... trial tests an experimental treatment on a small group of often healthy people (20 to 80), to ...

  4. 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...

  5. Participating in Clinical Trials

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    Full Text Available ... Learn More Participating in Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in ...

  6. Participating in Clinical Trials

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    Full Text Available ... in this topic was provided by the National Library of Medicine Topic last reviewed: December 2013 For ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ...

  7. 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.

  8. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Videos quiz yourself MedlinePlus for More Information National Institute on Aging Related Topics Talking with Your Doctor Taking Medicines The information in this topic was provided by the National ...

  9. Complementary and Alternative Medicine Cancer Clinical Trials

    Science.gov (United States)

    ... Introduction Cancer CAM Clinical Trials Introduction What are clinical trials? A clinical trial is one of the final ... and effective. What are the different types of clinical trials? Treatment trials test new treatments (like a new ...

  10. Adaptive trial designs.

    Science.gov (United States)

    Lai, Tze Leung; Lavori, Philip William; Shih, Mei-Chiung

    2012-01-01

    We review adaptive designs for clinical trials, giving special attention to the control of the Type I error in late-phase confirmatory trials, when the trial planner wishes to adjust the final sample size of the study in response to an unblinded analysis of interim estimates of treatment effects. We point out that there is considerable inefficiency in using the adaptive designs that employ conditional power calculations to reestimate the sample size and that maintain the Type I error by using certain weighted test statistics. Although these adaptive designs have little advantage over familiar group-sequential designs, our review also describes recent developments in adaptive designs that are both flexible and efficient. We also discuss the use of Bayesian designs, when the context of use demands control over operating characteristics (Type I and II errors) and correction of the bias of estimated treatment effects. PMID:21838549

  11. Participating in Clinical Trials

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    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... experimental treatment on a small group of often healthy people (20 to 80), to judge its safety ...

  12. Participating in Clinical Trials

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    Full Text Available ... to find out if an 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 ... universities and medical centers across the country. The National Institutes of ...

  13. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... care trials, researchers look for ways to make life better for people living with a life threatening disease or chronic health problem. The goal ... to obtain preliminary data on whether the drug works in people who have a certain disease or ...

  14. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    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...

  15. Randomized clinical trial

    DEFF Research Database (Denmark)

    Olesen, Anne Estrup; Nielsen, Lecia Møller; Larsen, Isabelle Myriam;

    2015-01-01

    : The study was a randomized, double-blinded, placebo-controlled, crossover trial in healthy males. Esophageal electrical, thermal, mechanical, and chemical stimulations were performed, pain perception was rated, and referred pain areas were drawn. Sensitization was induced by intraluminal esophageal acid...

  16. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... are usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, ... hundred to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial ...

  17. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... Reports Clinician Tools Clinician Tools Home Guidelines and Best Practices Topic Reviews Algorithms, Screens, Toolkits Provider Education Provider ... about federally and privately supported clinical research in human volunteers. Site gives information about a trial's purpose, who may participate, locations, and phone ... Forms State and Local Resources Strat Plan FY 2014-2020 VA Plans, Budget, & ...

  18. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... usually described based on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 ... to about 3,000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, ...

  19. 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 b...

  20. 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 ...

  1. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

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

    2015-01-01

    the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... starting enrolment before 2010 to 63.2% after 2010 (24/38, P randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...

  2. 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....... consisting of cardiovascular death, non-fatal stroke or myocardial infarction and hospitalisation for congestive heart failure. Patient selection and study procedures followed the previous HOPE trial. In the parallel TRANSCEND study, nearly 6.000 patients, all intolerant to ACE inhibition, were subjected...

  3. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

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

    2015-01-01

    members voted we calculated the median score among the nine members of the working group who completed the score. The document includes 25 recommendations regarding randomization, blocking and stratification, blinding, enhancing accuracy of patient-reported outcomes (PRO), selecting a study population and......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...... reporting of clinical trials for knee OA we initially drafted recommendations through an iterative process. Members of the working group included representatives from industry and academia. After the working group members reviewed a final draft, they scored the appropriateness for recommendations. After the...

  4. a randomized, controlled trial

    OpenAIRE

    Reinecke, Franziska

    2010-01-01

    The polycystic ovarian syndrome (PCOS) is characterized by hyperandrogenism and associated with obesity and impaired glucose metabolism. Despite the high prevalence of PCOS and the considerable clinical impact, the precise interplay between metabolism and hyperandrogenemia is not entirely clear. To analyse the effects of intravenous lipid and heparin infusion on circulating androgen levels in healthy women, we performed a randomized controlled cross-over trial. 12 healthy young women durin...

  5. Randomised clinical trial

    DEFF Research Database (Denmark)

    Meineche-Schmidt, V.; Christensen, E.; Bytzer, P.

    2011-01-01

    Background: Response to proton pump inhibitor (PPI) treatment in dyspepsia is unpredictable. Aim: To identify symptoms associated with response to esomeprazole in order to target patients for empirical treatment. Methods: Eight hundred and five uninvestigated, primary care patients with upper GI ....... Conclusions In patients with uninvestigated dyspepsia, PPI responders can be reliably identified by a simple pocket chart using symptoms and patient characteristics (ClinicalTrials.gov NCT00318968). © 2010 Blackwell Publishing Ltd....

  6. NATO SOCMET trials

    Science.gov (United States)

    Jenden, C. M.

    1993-11-01

    During 1993, Canada, France, Germany and the United Kingdom will be participating in the Smoke and Obscurants Countermeasures Materials Evaluation Tests (SOCMET). The tests will be carried out under the auspices of the NATO Army Armaments Group, AC/225, Panel VI, Sub-Panel 7 whose interests include multispectral smoke screening systems. The tests will comprise two sets of trials; one under cold climate conditions in Quebec, Canada, during February/March 1993 and the other in temperate conditions in Bourges, France during September 1993. This paper provides an insight into the management and aims of SOCMET. The evaluations will be seeking to identify candidate materials which create effective obscurant screens in the visible, infrared and millimetric bands of the electromagnetic spectrum. These materials will be disseminated through a range area dispersal. A key element of the trials will be the evaluation of field test instrumentation which may eventually lead to the development of standardized evaluation techniques. Following the trials, a scientific workshop will be held to review the results. A final report will be presented to NATO which will form the basis of future collaborative developments on multispectral screening systems leading towards standard NATO documentation on smoke and obscurant systems.

  7. Coagulation factor concentrate-based therapy for remote damage control resuscitation (RDCR): a reasonable alternative?

    Science.gov (United States)

    Maegele, Marc

    2016-04-01

    The concept of remote damage control resuscitation (RDCR) is still in its infancy and there is significant work to be done to improve outcomes for patients with life-threatening bleeding secondary to injury. The prehospital phase of resuscitation is critical and if shock and coagulopathy can be rapidly minimized before hospital admission this will very likely reduce morbidity and mortality. The optimum transfusion strategy for these patients is still highly debated and the potential implications of the recently published pragmatic, randomize, optimal platelet, and plasma ratios trial (PROPPR) for RDCR have been reviewed. Identifying the appropriate transfusion strategy is mandatory before adopting prehospital hemostatic resuscitation strategies. An alternative approach is based on the early administration of coagulation factor concentrates combined with the antifibrinolytic tranexamic acid (TXA). The three major components to this approach in the context of RDCR target the following steps to achieve hemostasis: 1) stop (hyper)fibrinolysis; 2) support clot formation; and 3) increase thrombin generation. Strong evidence exists for the use of TXA. The data from the prospective fibrinogen in trauma induced coagulopathy (FIinTIC) study will inform on the prehospital use of fibrinogen in bleeding trauma patients. Deficits in thrombin generation may be addressed by the administration of prothrombin complex concentrates. Handheld point-of-care devices may be able to support and guide the prehospital and remote use of intravenous hemostatic agents including coagulation factor concentrates along with clinical presentation, assessment, and the extent of bleeding. Combinations may even be more effective for bleeding control. More studies are urgently needed. PMID:27100752

  8. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-10-01

    Gateways to clinical trials is a guide to the most recent 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(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (+)-Dapoxetine hydrochloride, (S)-Tenatoprazole sodium salt monohydrate 19-28z, Acotiamide hydrochloride hydrate, ADV-TK, AE-37, Aflibercept, Albinterferon alfa-2b, Aliskiren fumarate, Asenapine maleate, Axitinib; Bavituximab, Becatecarin, beta-1,3/1,6-Glucan, Bevacizumab, Bremelanotide; Calcipotriol/betamethasone dipropionate, Casopitant mesylate, Catumaxomab, CDX-110, Cediranib, CMD-193, Cositecan; Darinaparsin, Denosumab, DP-b99, Duloxetine hydrochloride; E75, Ecogramostim, Elacytarabine, EMD-273063, EndoTAG-1, Enzastaurin hydrochloride, Eplerenone, Eribulin mesilate, Esomeprazole magnesium, Etravirine, Everolimus, Ezetimibe; Faropenem daloxate, Febuxostat, Fenretinide; Ghrelin (human); I-131 ch-TNT-1/B, I-131-3F8, Iclaprim, Iguratimod, Iloperidone, Imatinib mesylate, Inalimarev/Falimarev, Indacaterol, Ipilimumab, Iratumumab, Ispinesib mesylate, Ixabepilone; Lapatinib ditosylate, Laquinimod sodium, Larotaxel dehydrate, Linezolid, LOR-2040; Mapatumumab, MKC-1, Motesanib diphosphate, Mycophenolic acid sodium salt; NK-012; Olanzapine pamoate, Oncolytic HSV, Ortataxel; Paclitaxel nanoparticles, Paclitaxel poliglumex, Paliperidone palmitate, Panitumumab, Patupilone, PCV-9, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pertuzumab, Picoplatin, Pimavanserin tartrate, Pimecrolimus, Plerixafor hydrochloride, PM-02734, Poly I:CLC, PR1, Prasugrel, Pregabalin, Progesterone caproate, Prucalopride, Pumosetrag hydrochloride; RAV-12, RB-006, RB-007, Recombinant human erythropoietin alfa, Rimonabant, Romidepsin; SAR-109659, Satraplatin, Sodium butyrate; Tadalafil, Talampanel, Tanespimycin, Tarenflurbil, Tariquidar

  9. 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

  10. Gateways to clinical trials.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2010-11-01

    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 Thomson Reuters Integrity(SM), the drug discovery and development portal, http://www.thomsonreutersintegrity.com. This issue focuses on the following selection of drugs: Abatacept, Adalimumab, AdCD40L, Adefovir, Aleglitazar, Aliskiren fumarate, AM-103, Aminolevulinic acid methyl ester, Amlodipine, Anakinra, Aprepitant, Aripiprazole, Atazanavir sulfate, Axitinib; Belimumab, Bevacizumab, Bimatoprost, Bortezomib, Bupropion/naltrexone; Calcipotriol/betamethasone dipropionate, Certolizumab pegol, Ciclesonide, CYT-997; Darbepoetin alfa, Darunavir, Dasatinib, Desvenlafaxine succinate, Dexmethylphenidate hydrochloride cogramostim; Eltrombopag olamine, Emtricitabine, Escitalopram oxalate, Eslicarbazepine acetate, Eszopiclone, Etravirine, Everolimus-eluting coronary stent, Exenatide, Ezetimibe; Fenretinide, Filibuvir, Fludarabine; Golimumab; Hepatitis B hyperimmunoglobulin, HEV-239, HP-802-247, HPV-16/18 AS04, HPV-6/11/16/18, Human albumin, Human gammaglobulin; Imatinib mesylate, Inotuzumab ozogamicin, Invaplex 50 vaccine; Lapatinib ditosylate, Lenalidomide, Liposomal doxorubicin, Lopinavir, Lumiliximab, LY-686017; Maraviroc, Mecasermin rinfabate; Narlaprevir; Ocrelizumab, Oral insulin, Oritavancin, Oxycodone hydrochloride/naloxone; Paclitaxel-eluting stent, Palonosetron hydrochloride, PAN-811, Paroxetine, Pazopanib hydrochloride, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Pitavastatin calcium, Posaconazole, Pregabalin, Prucalopride succinate; Raltegravir potassium, Ranibizumab, RHAMM R3 peptide, Rosuvastatin calcium; Salclobuzic acid sodium salt, SCY-635, Selenate sodium, Semapimod hydrochloride, Silodosin, Siltuximab, Silybin, Sirolimus-eluting stent, SIR-Spheres, Sunitinib malate; Tapentadol hydrochloride, Tenofovir disoproxil

  11. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.; Finch, C. F.; Bennell, K. L.; Story, B.; Spindler, K.; Kemp, J.; Lohmander, L. S.

    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...... regarding the research question, research design, study participants, randomization, baseline characteristics, intervention, outcome measurement, analysis, implementation, cost evaluation, reporting and future considerations including the impact on development of PTOA. Methodological recommendations for...... will facilitate between study comparisons to inform best practice in injury prevention that will have the greatest public health impact....

  12. Gateways to clinical trials.

    Science.gov (United States)

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

    2002-01-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses, which has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the world's first drug discovery and development portal, providing information on study design, treatments, conclusions and references. This issue focuses on the following selection of drugs: Abacavir sulfate; abciximab; abetimus sodium; adalimumab; aldesleukin; almotriptan; alteplase; amisulpride; amitriptyline hydrochloride; amoxicillin trihydrate; atenolol; atorvastatin calcium; atrasentan; Beclometasone dipropionate; bosentan; Captopril; ceftriaxone sodium; cerivastatin sodium; cetirizine hydrochloride; cisplatin; citalopram hydrobromide; Dalteparin sodium; darusentan; desirudin; digoxin; Efalizumab; enoxaparin sodium; ertapenem sodium; esomeprazole magnesium; estradiol; ezetimibe; Famotidine; farglitazar; fluorouracil; fluticasone propionate; fosamprenavir sodium; Glibenclamide; glucosamine sulfate; Heparin sodium; HSPPC-96; hydrochlorothiazide; Imatinib mesilate; implitapide; Lamivudine; lansoprazole; lisinopril; losartan potassium; l-Propionylcarnitine; Melagatran; metformin hydrochloride; methotrexate; methylsulfinylwarfarin; Nateglinide; norethisterone; Olmesartan medoxomil; omalizumab; omapatrilat; omeprazole; oseltamivir phosphate; oxatomide; Pantoprazole; piperacillin sodium; pravastatin sodium; Quetiapine hydrochloride; Rabeprazole sodium; raloxifene hydrochloride; ramosetron hydrochloride; ranolazine; rasburicase; reboxetine mesilate; recombinant somatropin; repaglinide; reteplase; rosiglitazone; rosiglitazone maleate; rosuvastatin calcium; Sertraline; simvastatin; sumatriptan succinate; Tazobactam sodium; tenecteplase; tibolone; tinidazole; tolterodine tartrate; troglitazone; Uniprost; Warfarin sodium; Ximelagatran. PMID:11980386

  13. Japan nuclear ship sea trial

    Energy Technology Data Exchange (ETDEWEB)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko [Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment] [and others

    1992-01-01

    The sea trial of the first Japan nuclear Ship `MUTSU` was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).

  14. Japan nuclear ship sea trial

    Energy Technology Data Exchange (ETDEWEB)

    Yamazaki, Hiroshi; Kitamura, Toshikatus; Mizushima, Toshihiko (Japan Atomic Energy Research Inst., Mutsu, Aomori (Japan). Mutsu Establishment) (and others)

    1992-01-01

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author).

  15. Japan nuclear ship sea trial

    International Nuclear Information System (INIS)

    The sea trial of the first Japan nuclear Ship 'MUTSU' was conducted from the end of October to December in 1990. The purpose of the sea trial was to verify the nuclear propulsive performances and maneuverabilities. The present report describes the results of the sea trial. These results are classified into four items: 1. Speed test and engineering performance tests 2. Maneuvering performance tests 3. Vibration tests 4. Other tests. Acceptable performances were demonstrated, as expected in the original design. The experience of the use of the Global Positioning System (GPS), which were newly adopted for the sea trial, is also reported. (author)

  16. The FOCUS trial

    DEFF Research Database (Denmark)

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

    2015-01-01

    BACKGROUND: Cognitive deficits are a distinct feature among people at ultra-high risk (UHR) for psychosis and pose a barrier to functional recovery. Insufficient evidence exists on how to ameliorate these cognitive deficits in patients at UHR for psychosis and hence improve daily living and quality...... the cognitive training to their everyday lives. Follow-up assessments will be conducted at 6 and 12 months after randomisation. The primary outcome is the composite score on the Brief Assessment of Cognition in Schizophrenia at cessation of treatment after 6 months. Secondary outcomes are social and......-blinded clinical 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...

  17. 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)

  18. 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...

  19. Topics in clinical trial management

    NARCIS (Netherlands)

    B.A. Kirwan (Bridget Anne)

    2004-01-01

    textabstractThe aim of this thesis is to show how clinical trial conduct can be managed while respecting the underlying scientific principles. Chapter 2 describes the main results of PICO (PImobendan in COngestive heart failure), a trial which investigated a positive inotropic agent in patients with

  20. Market trials of irradiated chicken

    International Nuclear Information System (INIS)

    The potential market for irradiated chicken breasts was investigated using a mail survey and a retail trial. Results from the mail survey suggested a significantly higher level of acceptability of irradiated chicken than did the retail trial. A subsequent market experiment involving actual purchases showed levels of acceptability similar to that of the mail survey when similar information about food irradiation was provided

  1. 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

  2. Quinapril decreases antifibrinolytic and prooxidative potential of propofol in arterial thrombosis in hypertensive rats.

    Science.gov (United States)

    Wojewodzka-Zelezniakowicz, Marzena; Kisiel, Wioleta; Kramkowski, Karol; Gromotowicz-Poplawska, Anna; Zakrzeska, Agnieszka; Stankiewicz, Adrian; Kolodziejczyk, Patrycjusz; Szemraj, Janusz; Ladny, Jerzy Robert; Chabielska, Ewa

    2016-04-01

    Angiotensin converting enzyme inhibitors and propofol both exert hypotensive action and may affect hemostasis. We investigated the influence of quinapril and propofol on hemodynamics and hemostasis in renal-hypertensive rats with induced arterial thrombosis. Two-kidney, one clip hypertensive rats were treated with quinapril (3.0 mg/kg for 10 days), and then received propofol infusion (15 mg/kg/h) during ongoing arterial thrombosis. The hemodynamic and hemostatic parameters were assayed. Quinapril exerted a hypotensive effect increasing after propofol infusion. Quinapril showed an antithrombotic effect with the platelet adhesion reduction, fibrinolysis enhancement and oxidative stress reduction. Propofol did not influence thrombosis; however, it inhibited fibrinolysis and showed prooxidative action. The effect of propofol on fibrinolysis and oxidative stress was significantly lower in quinapril-pretreated rats. Mortality was increased among rats treated with both drugs together. Our study demonstrates that pretreatment with quinapril reduced the adverse effects of propofol on hemostasis. Unfortunately, co-administration of both drugs potentiated hypotension in rats, which corresponds to higher mortality. PMID:27169890

  3. 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. |

  4. Gateways to clinical trials.

    Science.gov (United States)

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

    2005-06-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables 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: Abiraterone acetate, acyline, adalimumab, adenosine triphosphate, AEE-788, AIDSVAX gp120 B/B, AK-602, alefacept, alemtuzumab, alendronic acid sodium salt, alicaforsen sodium, alprazolam, amdoxovir, AMG-162, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, aminophylline hydrate, anakinra, anecortave acetate, anti-CTLA-4 MAb, APC-8015, aripiprazole, aspirin, atazanavir sulfate, atomoxetine hydrochloride, atorvastatin calcium, atrasentan, AVE-5883, AZD-2171; Betamethasone dipropionate, bevacizumab, bimatoprost, biphasic human insulin (prb), bortezomib, BR-A-657, BRL-55730, budesonide, busulfan; Calcipotriol, calcipotriol/betamethasone dipropionate, calcium folinate, capecitabine, capravirine, carmustine, caspofungin acetate, cefdinir, certolizumab pegol, CG-53135, chlorambucil, ciclesonide, ciclosporin, cisplatin, clofarabine, clopidogrel hydrogensulfate, clozapine, co-trimoxazole, CP-122721, creatine, CY-2301, cyclophosphamide, cypher, cytarabine, cytolin; D0401, darbepoetin alfa, darifenacin hydrobromide, DASB, desipramine hydrochloride, desloratadine, desvenlafaxine succinate, dexamethasone, didanosine, diquafosol tetrasodium, docetaxel, doxorubicin hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecallantide, efalizumab, efavirenz, eletriptan, emtricitabine, enfuvirtide, enoxaparin sodium, estramustine phosphate sodium, etanercept, ethinylestradiol, etonogestrel, etonogestrel/ethinylestradiol, etoposide, exenatide; Famciclovir, fampridine, febuxostat, filgrastim, fludarabine phosphate, fluocinolone acetonide, fluorouracil, fluticasone propionate

  5. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  6. 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. PMID:24857086

  7. 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.)

  8. 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.

  9. The ALCHEMIST Lung Cancer Trial

    Science.gov (United States)

    A collection of material about the ALCHEMIST lung cancer trial that will examine tumor tissue from patients with early-stage, completely resected lung cancer for gene mutations in the EGFR and ALK genes, and a

  10. Types of Treatment: Clinical Trials

    Science.gov (United States)

    ... Previous Article Palliative Care Next Article How a Clinical Trial Works Follow us Subscribe to a newsletter This field is required ... Fundraising Disclosure Refund Policy Work for LLS Contact Us Email Subscription Center

  11. Global warming on trial

    International Nuclear Information System (INIS)

    Jim Hansen, a climatologist at NASA's Goddard Space Institute, is convinced that the earth's temperature is rising and places the blame on the buildup of greenhouse gases in the atmosphere. Unconvinced, John Sununu, former White House chief of staff, doubts that the warming will be great enough to produce serious threat and fears that measures to reduce the emissions would throw a wrench into the gears that drive the Unites States' troubled economy. During his three years at the White House, Sununu's view prevailed, and although his role in the debate has diminished, others continue to cast doubt on the reality of global warming. A new lobbying group called the Climate Council has been created to do just this. Burning fossil fuels is not the only problem; a fifth of emissions of carbon dioxide now come from clearing and burning forests. Scientists are also tracking a host of other greenhouse gases that emanate from a variety of human activities; the warming effect of methane, chlorofluorocarbons and nitrous oxide combined equals that of carbon dioxide. Although the current warming from these gases may be difficult to detect against the background noise of natural climate variation, most climatologists are certain that as the gases continue to accumulate, increases in the earth's temperature will become evident even to skeptics. If the reality of global warming were put on trial, each side would have trouble making its case. Jim Hansen's side could not prove beyond a reasonable doubt that carbon dioxide and other greenhouse gases have warmed the planet. But neither could John Sununu's side prove beyond a reasonable doubt that the warming expected from greenhouse gases has not occurred. To see why each side would have difficulty proving its case, this article reviews the arguments that might be presented in such a hearing

  12. Collaborative trial on groundwater sampling

    OpenAIRE

    Ghestem, Jean Philippe; Fisicaro, Paula; Champion, Rachel

    2011-01-01

    The trial presented here was conducted by BRGM in collaboration with LNE under the work program AQUAREF 2009 with the support of ONEMA. This is a collaborative trial on groundwater sampling and on field physico chemical measurement. It is not a proficiency test. He had three goals: * Observe and evaluate the practices of groundwater sampling to improve future guides, standards and specifications. * Assess the impact of sampling on variability of results. * Study the accuracy of field measurem...

  13. Decision analysis and bioequivalence trials

    OpenAIRE

    Lindley, Dennis V.

    1998-01-01

    It is argued that the determination of bioequivalence involves a decision, and is not purely a problem of inference. A coherent method of decision-making is examined in detail for a simple trial of bioequivalence. The result is shown to differ seriously from the inferential method, using significance tests, ordinarily used. The reason for the difference is explored. It is shown how the decision-analytic method can be used in more complicated and realistic trials and the case...

  14. Malaria Diagnostics in Clinical Trials

    OpenAIRE

    Murphy, Sean C.; Shott, Joseph P.; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V. Ann

    2013-01-01

    Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wi...

  15. Acupuncture trials and informed consent

    OpenAIRE

    Miller, F. G.; Kaptchuk, T J

    2007-01-01

    Participants are often not informed by investigators who conduct randomised, placebo‐controlled acupuncture trials that they may receive a sham acupuncture intervention. Instead, they are told that one or more forms of acupuncture are being compared in the study. This deceptive disclosure practice lacks a compelling methodological rationale and violates the ethical requirement to obtain informed consent. Participants in placebo‐controlled acupuncture trials should be provided an accurate disc...

  16. Common statistical concerns in clinical trials

    OpenAIRE

    Evans, Scott R.

    2010-01-01

    Statistics are an integral part of clinical trials. Elements of statistics span clinical trial design, data monitoring, analyses, and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of clinical trials. This manuscript outlines common statistical concerns in clinical trials that are important for clinicians to understand.

  17. 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...

  18. Interventional trials in atypical parkinsonism.

    Science.gov (United States)

    Eschlböck, S; Krismer, F; Wenning, G K

    2016-01-01

    Atypical parkinson disorders (APD) are rapidly progressive neurodegenerative diseases with a variable clinical presentation that may even mimic Parkinson's disease. Multiple system atrophy (MSA), progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) are commonly summarized under this umbrella term. Significant developments in research have expanded knowledge and have broadened available symptomatic treatments, particularly for the treatment of neurogenic orthostatic hypotension. Nonetheless, symptomatic support still remains limited in all of these disorders. Currently, there exists no effective treatment to delay disease progression and disease-modifying trials have failed to provide coherent and convincing results. Recent trials of rasagiline (in MSA), rifampicin (in MSA), tideglusib (in PSP) and davunetide (in PSP) reported negative results. Nevertheless, large cohorts of patients were recruited for interventional studies in the last few years which improved our understanding of trial methodology in APDs immensely. In addition, remarkable progress in basic research has been reported recently and will provide a solid foundation for future therapeutic trials. In this review, we will summarize published randomized, placebo-controlled clinical trials (RCTs) in APDs. Additionally, the design of ongoing and unpublished interventions will be presented. PMID:26421389

  19. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

    OpenAIRE

    Prayle, A.P.; Hurley, M.N.; Smyth, Alan R

    2012-01-01

    Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Design Registry based study of clinical trial summaries. Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one...

  20. POST - SURGICAL WOUND CARE IN ORTHOPEDICS: ROLE OF TRANEXAMIC ACID

    Directory of Open Access Journals (Sweden)

    Anil

    2015-04-01

    Full Text Available Post - surgical infections constitutes a major cause of morbidity and mortality in post - operative patients in orthopaedics . Most of these are hospital acquired and organisms being resistant to major antibiotics and patients are not in a condition to be discharged from hospital. The aim of the present study was to analyze the role of Tranexaemic acid in prevention of wound inf ection in post - operative patients. A total of 120 patients were taken of which 30 each were operated for spine , intertrochanteric fractures , bipolar hemiarthroplasty and general orthopaedics ( F orearm plating , distal humeral plating , philos. Age of the pat ient were taken between 18 to 65 years. Males formed about 60% of the patients. Duration from injury to surgery was 3.56 days. Two patients out of 60 on tranexaemic acid were infected whereas 4 out of 60 patients who were not given the medicine were infected. The drug proves to be also effective in reducing wound dehiscence rate , need of prolonged antibiotics and thus overall reduces the postoperative morbidity in pa tients.

  1. Is tranexamic acid effective for acute upper gastrointestinal bleeding?

    Directory of Open Access Journals (Sweden)

    Sebastián Flores

    2015-12-01

    Full Text Available La hemorragia digestiva alta corresponde a una emergencia médico-quirúrgica debido a la alta morbilidad y mortalidad que conlleva. El ácido tranexámico, un antifibrinolítico, podría ayudar a lograr un control precoz del sangrado, sin embargo existe controversia sobre su real utilidad. Utilizando la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en 30 bases de datos, identificamos cinco revisiones sistemáticas que en conjunto incluyen ocho estudios aleatorizados. Realizamos un metanálisis y tablas de resumen de los resultados utilizando el método GRADE. Concluimos que el ácido tranexámico probablemente disminuye el resangrado y la mortalidad, y no aumenta los efectos adversos tromboembólicos en pacientes con hemorragia digestiva alta.

  2. Is tranexamic acid effective for acute upper gastrointestinal bleeding?

    OpenAIRE

    Sebastián Flores; Carolina Avilés; Gabriel Rada

    2015-01-01

    La hemorragia digestiva alta corresponde a una emergencia médico-quirúrgica debido a la alta morbilidad y mortalidad que conlleva. El ácido tranexámico, un antifibrinolítico, podría ayudar a lograr un control precoz del sangrado, sin embargo existe controversia sobre su real utilidad. Utilizando la base de datos Epistemonikos, la cual es mantenida mediante búsquedas en 30 bases de datos, identificamos cinco revisiones sistemáticas que en conjunto incluyen ocho estudios aleatorizados. Realizam...

  3. Use of tranexamic acid in anticoagulated oral surgery patients

    OpenAIRE

    Dimova, Cena; Papakoca, Kiro; Kovacevska, Ivona; Kamceva, Gordana

    2010-01-01

    INTRODUCTIONS: The oral surgeons are frequently asked to manage patients who are receiving oral anticoagulants. The goal of treatment is to minimize the risk of hemorrhage while continuing to protect the patient against thromboembolism formation. The ordinary treatment includes the interruption of anticoagulant therapy for oral surgery interventions to prevent hemorrhage. AIM:However, this practice may logically increase the risk of a potentially life-threatening thromboembolism. Thus, thi...

  4. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian; Perko, Mario J; Lund, Jens T; Andersen, Lars Willy; Madsen, Jan Kyst; Hughes, Pia; Steinbrüchel, Daniel A

    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...

  5. Trials with a Strain Gauge.

    Science.gov (United States)

    Auty, Geoff

    1996-01-01

    Describes an attempt to match the goals of the practical demonstration of the use of a strain gauge and the technical applications of science and responding to student questions in early trials, while keeping within the level of electronics in advanced physics. (Author/JRH)

  6. Ongoing clinical trials in AKI.

    Science.gov (United States)

    Faubel, Sarah; Chawla, Lakhmir S; Chertow, Glenn M; Goldstein, Stuart L; Jaber, Bertrand L; Liu, Kathleen D

    2012-05-01

    AKI is an important public health issue. AKI is a common hospital complication associated with increased in-hospital and long-term mortality, extensive morbidity (including prolonged hospital length of stay), and an estimated annual cost of at least $10 billion in the United States. At present, no specific therapy has been developed to prevent AKI, hasten recovery of kidney function, or abrogate the deleterious systemic effects of AKI. However, recent progress includes establishing a consensus definition of AKI and discovery of novel biomarkers that may allow early detection of AKI. Furthermore, significant insights into the pathophysiology of AKI and its deleterious systemic effects have been gleaned from animal studies. Urgently needed are large, definitive randomized clinical trials testing interventions to prevent and/or treat AKI. This review summarizes and analyzes current ongoing clinical trials registered with clinicaltrials.gov that address prevention or management of AKI. The purpose of this review is to provide a resource for people interested in potential prophylactic and therapeutic approaches to patient care and investigators hoping to plan and execute the next round of randomized clinical trials. Finally, this review discusses research needs that are not addressed by the current clinical trials portfolio and suggests key areas for future research in AKI. PMID:22442183

  7. 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...... discussed by a group of trialists. This review focuses on the arguments for conducting posttrial database studies and presents examples of studies in which posttrial knowledge generation has been substantial. Possible strategies to ensure successful trial database or biobank generation are discussed, in...

  8. 25 CFR 11.314 - Jury trials.

    Science.gov (United States)

    2010-04-01

    ... Criminal Procedure § 11.314 Jury trials. (a) A defendant has a right, upon demand, to a jury trial in any criminal case: (1) That is punishable by a maximum sentence of one year incarceration; or (2) In which...

  9. 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 ...

  10. Strategies to improve retention in randomised trials

    OpenAIRE

    Brueton, V. C.; Tierney, J.; Stenning, S; Harding, S; Meredith, S.; Nazareth, I; Rait, G

    2013-01-01

    Background Loss to follow-up from randomised trials can introduce bias and reduce study power, affecting the generalisability, validity and reliability of results. Many strategies are used to reduce loss to follow-up and improve retention but few have been formally evaluated. Objectives To quantify the effect of strategies to improve retention on the proportion of participants retained in randomised trials and to investigate if the effect varied by trial strategy and trial setting. Search met...

  11. Sample Size Estimation in Clinical Trial

    OpenAIRE

    Tushar Vijay Sakpal

    2010-01-01

    Every clinical trial should be planned. This plan should include the objective of trial, primary and secondary end-point, method of collecting data, sample to be included, sample size with scientific justification, method of handling data, statistical methods and assumptions. This plan is termed as clinical trial protocol. One of the key aspects of this protocol is sample size estimation. The aim of this article is to discuss how important sample size estimation is for a clinical trial, and a...

  12. Data considerations in ischemic stroke trials

    OpenAIRE

    Liebeskind, David S.; Feldmann, Edward

    2014-01-01

    Data drive the analyses of any ischemic stroke trial, culminating in the main results and potential next steps. The distinct purpose of a given trial, advancing a novel treatment or examining routine clinical practice, determines the nature of essential data elements. Information gathering for an effective trial depends on ample data, adequate infrastructure, and properly planned statistical analyses. This review highlights the fact that successful future trials will require appropriate exper...

  13. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    HIV Prevention HIV/AIDS Clinical Trials (Last updated 9/15/2015; last reviewed 9/15/2015) Key Points HIV/AIDS clinical ... safe and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help ...

  14. 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.

  15. Enhancing Adherence in Clinical Exercise Trials.

    Science.gov (United States)

    O'Neal, Heather A.; Blair, Steven N.

    2001-01-01

    Discusses exercise adherence from the perspective of adhering to an exercise treatment in a controlled trial, focusing on: adherence (to intervention and measurement); the development of randomized clinical trials; exemplary randomized clinical trials in exercise science (exercise training studies and physical activity interventions); and study…

  16. 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…

  17. What Are Clinical Trials? | NIH MedlinePlus the Magazine

    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 ...

  18. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  19. Quality of Variational Trial States

    CERN Document Server

    Lucha, Wolfgang; Lucha, Wolfgang; Schoberl, Franz F.

    1999-01-01

    Besides perturbation theory (which clearly requires the knowledge of the exact unperturbed solution), variational techniques represent the main tool for any investigation of the eigenvalue problem of some semibounded operator H in quantum theory. For a reasonable choice of the employed trial subspace of the domain of H, the lowest eigenvalues of H usually can be located with acceptable precision whereas the trial-subspace vectors corresponding to these eigenvalues approximate, in general, the exact eigenstates of H with much less accuracy. Accordingly, various measures for the accuracy of the approximate eigenstates derived by variational techniques are scrutinized. In particular, the matrix elements of the commutator of the operator H and (suitably chosen) different operators with respect to degenerate approximate eigenstates of H obtained by variational methods are proposed as new criteria for the accuracy of variational eigenstates. These considerations are applied to precisely that Hamiltonian for which t...

  20. Human clinical trials in antiepileptogenesis

    OpenAIRE

    Mani, Ram; Pollard, John; Dichter, Marc A.

    2011-01-01

    Blocking the development of epilepsy (epileptogenesis) is a fundamental research area with the potential to provide large benefits to patients by avoiding the medical and social consequences that occur with epilepsy and lifelong therapy. Human clinical trials attempting to prevent epilepsy (antiepileptogenesis) have been few and universally unsuccessful to date. In this article, we review data about possible pathophysiological mechanisms underlying epileptogenesis, discuss potential intervent...

  1. -ctgov-: A suite of Stata commands for reporting trial results to ClinicalTrials.gov

    OpenAIRE

    Phil Schumm; Theodore Karrison

    2014-01-01

    In response to the 1997 Food and Drug Administration Modernization Act (FDAMA), the National Institutes of Health (NIH) established ClinicalTrials.gov, an online, publicly-accessible registry for clinical trials. The 2007 Food and Drug Administration Amendments Act (FDAAA) broadened the scope of eligible trials, added outcomes reporting as a requirement, and established penalties for non-compliance. Although ClinicalTrials.gov increased the transparency with which clinical trials are conducte...

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

    OpenAIRE

    Ross, Joseph S.; Mulvey, Gregory K.; Hines, Elizabeth M.; Nissen, Steven E.; Krumholz, Harlan M.

    2009-01-01

    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 ...

  3. Automated Information Extraction of Key Trial Design Elements from Clinical Trial Publications

    OpenAIRE

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

    2008-01-01

    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...

  4. Potential Representation - Global vs. Local Trial Functions

    Science.gov (United States)

    Michel, Volker

    2014-05-01

    Many systems of trial functions are available for representing potential fields on the sphere or parts of the sphere. We distinguish global trial functions (such as spherical harmonics) from localized trial functions (such as spline basis functions, scaling functions, wavelets, and Slepian functions). All these systems have their own pros and cons. We discuss the advantages and disadvantages of several selected systems of trial functions and propose criteria for their applicability. Moreover, we present an algorithm which is able to combine different types of trial functions. This yields a sparser solution which combines the features of the different basis systems which are used.

  5. Effects of tranexamic acid impregnated gelatin sponge on postoperative bleeding after multi-segment lumbar vertebra surgery%氨甲环酸浸渍明胶海绵对腰椎手术患者术后出血的影响

    Institute of Scientific and Technical Information of China (English)

    张嘉男; 刘继军; 贺欣; 孟羿彬; 黄云飞; 吴起宁; 高林; 杨光; 郝定均

    2015-01-01

    背景:腰椎手术相关并发症的防治逐渐得到重视,但如何减少术后引流量较大导致的输血及住院时间延长鲜有报道。目的:探讨氨甲环酸(TXA)浸渍可吸收明胶海绵局部止血对腰椎多节段手术患者术后引流量及住院时间的影响。方法:本前瞻、随机对照研究纳入2013年7月至2014年12月行双节段腰椎后路减压融合术的患者80例。在关闭切口前随机将浸有氨甲环酸的明胶海绵应用于腰椎显露伤口中(试验组)或不做该止血措施(对照组)。手术均由同一主刀医师完成。比较两组术后总引流量、引流终止时间、术后住院时间、再入院人数及术后并发症。结果:共73例患者完成本研究,试验组35例,对照组38例。两组患者年龄、性别、体重指数、手术时间、术中失血量、术中输血例数、术中输血量无显著差异(P>0.05)。试验组的术后平均总引流量、引流时间及术后平均住院时间均显著少于对照组([213±127]ml vs [329±152]ml,[2.5±0.3]d vs [3.5±0.3]d,[3.1±0.7]d vs [4.1±0.7]d,P<0.05)。两组病例在出院后30 d内未出现局部用药相关的不良反应,未发现因相关并发症再入院者。结论:腰椎多节段手术中采用氨甲环酸浸渍可吸收明胶海绵止血可显著减少术后引流量,并缩短患者住院时长。%Background: The prevention and treatment of the complications of lumbar operation was gotten attention gradually. But how to reduce the postoperative wound volume of drainage and shorten the hospitalization time was reported rarely. Objective:To investigate clinical outcome of tranexamic acid (TXA) impregnated absorbable gelatin sponge for postopera-tive stop bleeding and hospitalization time in patients with surgical treatment of lumbar vertebrae. Methods: The consecutive 80 patients undergoing two-segment lumbar posterior decompression and intervertebral fusion from July

  6. 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...

  7. 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.

  8. Market Trials of Irradiated Spices

    International Nuclear Information System (INIS)

    Full text: The objectives of the experiment were to disseminate irradiated retail foods to the domestic publics and to test consumer acceptance on irradiated ground chilli and ground pepper. Market trials of irradiated ground chilli and ground pepper were carried out at 2 local markets and 4 in Bangkok and Nontaburi in 2005-2007. Before the start of the experiment, processing room, gamma irradiation room and labels of the products were approved by Food and Drug Administration, Thailand. 50 grams of irradiated products were packaged in plastic bags for the market trials. 688 and 738 bags of ground chilli and ground pepper were sold, respectively. Questionnaires distributed with the products were commented by 59 consumers and statistically analyzed by experimental data pass program. 88.1 and 91.4 percents of the consumers were satisfied with the quality and the price, respectively. 79.7% of the consumers chose to buy irradiated ground chilli and ground pepper because they believed that the quality of irradiated products were better than that of non-irradiated ones. 91.5% of the consumers would certainly buy irradiated chilli and pepper again. Through these market trials, it was found that all of the products were sold out and the majority of the consumers who returned the questionnaires was satisfied with the irradiated ground chilli and ground pepper and also had good attitude toward irradiated foods

  9. Acceptance Checklist for Clinical Effectiveness Pilot Trials: a systematic approach.

    OpenAIRE

    Charlesworth, G.; Burnell, K.; Hoe, J.; Orrell, M; Russell, I

    2013-01-01

    Conducting a pilot trial is important in preparing for, and justifying investment in, the ensuing larger trial. Pilot trials using the same design and methods as the subsequent main trial are ethically and financially advantageous especially when pilot and main trial data can be pooled. For explanatory trials in which internal validity is paramount, there is little room for variation of methods between the pilot and main trial. For pragmatic trials, where generalisability or external validity...

  10. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-01-01

    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. PMID:23561044

  11. 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.

  12. 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

  13. Contraceptive development and clinical trials.

    Science.gov (United States)

    Fraser, I S

    1986-02-01

    This article provides an overview of the contraceptive development process, with particular emphasis on the importance of clinical trials. Development of a new contraceptive drug begins with chemical synthesis of a large number of substances that may have antifertility effects. Before human trials are considered, drugs must undergo a complex process of animal toxicology testing. Such studies assess acute, subacute, and chronic toxicity. Once a drug has passed the initial screening process, human testing must follow a logical sequence of clinical trials: phase I, pharmacology testing; phase II, initial assessment of efficacy, safety, acceptability, and ease of use; phase III, acurate assessment of efficacy, side effects, and reasons for discontinuation under controlled conditions; and phase IV, evaluation of effectiveness under field conditions. When these have been satisfactorily completed, a detailed marketing application must be submitted to the drug regulatory agency in each country. The process of assessment of the application often takes as long as 2 years. Once marketing approval has been received, there is still a need for postmarketing surveillance of the performance of the new contraceptive method. In many cases, a careful program of training is required. Among the research and recording strategies for postmarketing surveillance are voluntary recording of possible adverse reactions, longterm prospective cohort studies, retrospective case-control studies, and registered release. As controls on the safety and performance of new contraceptive methods are being tightened, the time scale and costs of development are increasing. The time from the 1st synthesis of a drug to marketing approval often takes 13-14 years and costs US$25-50 million. Since the patent life of a new substance is limited to 17 years in most countries, pharmaceutical companies have little time to recoup development costs, which has caused fewer new methods to be developed. PMID:3708511

  14. Melanoma vaccines: trials and tribulations

    Directory of Open Access Journals (Sweden)

    Dillman RO

    2013-10-01

    Full Text Available Robert O Dillman1,21Hoag Cancer Institute and Hoag Institute for Research and Education, Newport Beach, CA, USA; 2University of California Irvine, Irvine, CA, USAAbstract: Metastatic melanoma has been a target of immunotherapy for more than 4 decades. Three immunotherapeutics have received regulatory approval for treating melanoma: interferon-alpha, interleukin-2, and ipilimumab. The antitumor mechanisms of these products depend on enhancing existing immune responses, including autoimmune effects. The combination of autologous, cytotoxic T-lymphocytes plus high-dose interleukin-2 is a promising patient-specific therapy, but has limited clinical application. Other approaches include vaccines targeting melanoma-associated antigens, and patient-specific vaccines that utilize autologous tumor. Non-patient-specific vaccine approaches target melanocyte differentiation antigens (eg, tyrosinase, Melan-A, gp100, antigens identified by cytotoxic T-lymphocytes (eg, NY-Eso-1, Melan-A/Mart-1, Mage-3, and antigens originally identified by murine monoclonal antibodies (gangliosides, gp97, gp225. Self-renewing cells in tumor cell lines may represent tumor stem cells, but vaccines derived from allogeneic tumor cell lines have yielded disappointing results in randomized trials. Patient-specific vaccines can be derived from bulk autologous tumor or autologous tumor cell lines, and intratumoral injections of immunostimulatory fusion products have shown promise. While technically more complex to manufacture, patient-specific vaccines derived from autologous tumor cell lines have the potential to target tumor stem cells and overcome interpatient tumor cell heterogeneity. This article reviews sources of melanoma-associated antigens, costimulatory agents, and clinical trial results for various melanoma vaccines. Comparing Phase II trials is difficult because of the wide range of vaccine strategies and the differences in study patient populations; therefore, randomized

  15. The L'Aquila trial

    OpenAIRE

    Cocco, M.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Cultrera, G.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Amato, A.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; Braun, T.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Cerase, A.; Dipartimento di Comunicazione e Ricerca Sociale, Univ. La Sapienza, Roma, Italy; Margheriti, L.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; Bonaccorso, A.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Catania, Catania, Italia; Demartin, M..; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; De Martini, P. M.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Galadini, F.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Meletti, C.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Milano-Pavia, Milano, Italia; Nostro, C.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione CNT, Roma, Italia; Pacor, F.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Milano-Pavia, Milano, Italia; Pantosti, D.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Roma1, Roma, Italia; Pondrelli, S.; Istituto Nazionale di Geofisica e Vulcanologia, Sezione Bologna, Bologna, Italia

    2015-01-01

    The first stage of the trial in L’Aquila (Italy) ended with a conviction of seven experts, convened by the head of Civil Protection on 31 March 2009, for multiple manslaughter and serious injuries. They were sentenced to six years in jail, perpetual interdiction from public office and a fine of several million euros to be paid to the victims of the earthquake of 6 April 2009 (moment magnitude 6.3) for having caused, by their negligent conduct, the death of 29 persons and the injury of seve...

  16. Lessons from the SYNTAX trial

    OpenAIRE

    Alamri, Hussein S.; Alotaiby, Mohammed; ALmoghairi, Abdulrahman; El Oakley, Rieda M.

    2010-01-01

    Despite the fact that CABG is the standard of care for patients with multivessel coronary arteries and/or left main stem stenosis, PCI has become a rival to CABG in patients with multivessel coronary artery disease or left main disease. However, the need for repeat revascularization, in-stent stenosis and thrombosis remain the achilis heal of PCI. SYNTAX trial randomized patients with left main disease and/or three-vessel disease to PCI with TAXus stent or CABG with the concept that PCI is no...

  17. 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. PMID:26593118

  18. Mobiilipeligrafiikan optimointi : Case: Trials Frontier

    OpenAIRE

    Palmi, Daniel

    2013-01-01

    Opinnäytetyön tavoitteena on tuoda esille merkittävimmät tekniikat ja seikat peligrafiikan optimointiin 3d-graafikon näkökulmasta. Oppimani tekniikat liittyvät tiiviisti Trials Frontier – mobiilipeliin, joka on kirjoitushetkellä kehitteillä Redlynx Ubisoft -studiossa. Olen projektis-sa 3d-graafikkona ja luonut peliin suurimman osan 3d-objekteista. Projektin parissa on työn kautta tullut opittua monia tekniikoita reaaliaikaisen grafiikan optimointiin ja esitän tässä opinnäytetyössä keskeisimmä...

  19. Trial and Numerical Analysis of Specimen Pipelay

    Institute of Scientific and Technical Information of China (English)

    何炎平; 邓德衡; 谭家华; 顾敏童

    2002-01-01

    Subsea pipelay has a relatively long history. In recent years, there has been a domestic need for the laying of largediameter thin wall pipes. A land-based trial for the large diameter thin wall specimen pipe is described in this paper. Re-gression analysis is performed for the trial data and the formula derived can express the trial data very well. Numericalanalysis is adopted to compute various trial conditions. Then the numerical model is revised with the trial results, whichare consistent with each other. After summarization of the results of trial and numerical analysis, the characteristics aredescribed of the spatial configuration during the laying of the pipe and it is concluded that the maximum strain appearsaround the center of the raised pipeline. In the end, a reference standard, which limits the maximum stress below theyield stress is provided.

  20. Civil society perspectives on negative biomedical HIV prevention trial results and implications for future trials.

    Science.gov (United States)

    Essack, Zaynab; Koen, Jennifer; Slack, Catherine; Lindegger, Graham; Newman, Peter A

    2012-01-01

    Community engagement is crucial to ongoing development and testing of sorely needed new biomedical HIV prevention technologies. Yet, negative trial results raise significant challenges for community engagement in HIV prevention trials, including the early termination of the Cellulose Sulfate microbicide trial and two Phase IIb HIV vaccine trials (STEP and Phambili). The present study aimed to explore the perspectives and experiences of civil society organization (CSO) representatives regarding negative HIV prevention trial results and perceived implications for future trials. We conducted in-depth interviews with 14 respondents from a broad range of South African and international CSOs, and analyzed data using thematic analysis. CSO representatives reported disappointment in response to negative trial results, but acknowledged such outcomes as inherent to clinical research. Respondents indicated that in theory negative trial results seem likely to impact on willingness to participate in future trials, but that in practice people in South Africa have continued to volunteer. Negative trial results were described as having contributed to improving ethical standards, and to a re-evaluation of the scientific agenda. Such negative results were identified as potentially impacting on funding for trials and engagement activities. Our findings indicate that trial closures may be used constructively to support opportunities for reflection and renewed vigilance in strategies for stakeholder engagement, communicating trial outcomes, and building research literacy among communities; however, these strategies require sustained resources for community engagement and capacity-building. PMID:22360605

  1. 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

  2. Traversing the Translational Trail for Trials

    OpenAIRE

    Steeves, John D.; John L. K. Kramer; Zariffa, Jose

    2012-01-01

    The principles of spinal cord injury clinical trial programs are briefly reviewed as one example of the challenge faced by most human studies of neurologically directed therapeutic interventions, including rehabilitation strategies. Different trial protocols are reviewed, as are inclusion/exclusion criteria for study subjects, the choice of clinical endpoints, and the statistical approaches that might be used in a trial program. Potential factors that might confound the accurate interpretatio...

  3. Clinical trials: innovation, progress and controversy

    OpenAIRE

    Martin GS

    2011-01-01

    Greg S MartinDepartment of Pulmonary, Allergy and Critical Care, Emory University, Atlanta, Georgia, USAThe Open Access Journal of Clinical Trials began in 2009 with the goal of being an authoritative, open access source for international, peer-reviewed publications in the field of human research and clinical trials. Since then, the Open Access Journal of Clinical Trials has published approximately 30 high-quality articles on original research, innovative reviews, and critical commentaries. T...

  4. The Clinical Trials Transformation Initiative (CTTI)

    OpenAIRE

    Alberto Grignolo

    2011-01-01

    The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership created in 2007 between the United States Food and Drug Administration (FDA) and Duke University for the purpose of identifying practices that will increase the quality and efficiency of clinical trials. The initiative was generated from the realization that the clinical trials system in the United States has been suffering as a result of increasingly longer study start-up times, slowing enrollment of patient...

  5. Methodological Issues in Negative Symptom Trials

    OpenAIRE

    Marder, Stephen R.; Daniel, David G; Alphs, Larry; Awad, A George; Richard S E Keefe

    2011-01-01

    Individuals from academia, the pharmaceutical industry, and the US Food and Drug Administration used a workshop format to discuss important methodological issues in the design of trials of pharmacological agents for improving negative symptoms in schizophrenia. The issues addressed included the need for a coprimary functional measure for registration trials; the characteristics of individuals who should enter negative symptom trials; the optimal duration for a proof-of-concept or registration...

  6. Strategies and Endpoints of Antifibrotic Drug Trials

    OpenAIRE

    Torok, Natalie; Jonathan A Dranoff; Schuppan, Detlef; Friedman, Scott L.

    2015-01-01

    There is an urgent need to develop antifibrotic therapies for chronic liver disease, and to clarify which endpoints in antifibrotic trials will be acceptable to regulatory agencies. AASLD sponsored an endpoints conference to help accelerate the efficient testing of antifibrotic agents and to develop recommendations on clinical trial design for liver fibrosis. In this review we summarize the salient and novel elements of this conference and provide directions for future clinical trial design. ...

  7. Potential bias in ophthalmic pharmaceutical clinical trials

    OpenAIRE

    Paul Varner

    2008-01-01

    Paul VarnerJohn J Pershing Veterans’ Administration Medical Center, Poplar Bluff, Missouri, USAAbstract: To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data an...

  8. 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

  9. 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.

  10. 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 a...... 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...

  11. 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 a...... 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...

  12. Clinical trials with fast neutrons in Europe

    International Nuclear Information System (INIS)

    There is an increasing number of European centres with facilities for fast neutron treatment. To prepare protocols for multi-centre trials and to make treatment results intercomparable, many obstacles have to be overcome. A provision for two dose levels in the neutron treatment arm of a trial could enable the estimation of the local cure rate for an acceptable late complication rate. The considerations on which future trials are based as well as the main characteristics of trials in progress in Europe are reported. (author)

  13. Relational Dynamics in Perception: Impacts on Trial-to-trial Variation

    OpenAIRE

    Shimon Marom

    2011-01-01

    We show that trial-to-trial variability in sensory detection of a weak visual stimulus is dramatically diminished when rather than presenting a fixed stimulus contrast, fluctuations in a subject's judgment are matched by fluctuations in stimulus contrast. This attenuation of fluctuations does not involve a change in the subject's psychometric function. The result is consistent with the interpretation of trial-to-trial variability in this sensory detection task being a high-level meta-cognitiv...

  14. Carbon cost of pragmatic randomised controlled trials: retrospective analysis of sample of trials

    OpenAIRE

    Lyle, Katy; Dent, Louise; Bailey, Sally; Kerridge, Lynn; Roberts, Ian; Milne, Ruairidh

    2009-01-01

    Objective To calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from a sample of pragmatic randomised controlled trials. Design Retrospective analysis. Data source Internal data held by NIHR Evaluation, Trials and Studies Coordinating Centre. Studies included All eligible pragmatic randomised controlled trials funded by the NIHR Health Technology Assessment programme during 2002 and 2003. Main outcome measure CO2 equivalents for trial activities calculated w...

  15. Making trials matter: pragmatic and explanatory trials and the problem of applicability

    OpenAIRE

    Treweek Shaun; Zwarenstein Merrick

    2009-01-01

    Abstract Randomised controlled trials are the best research design for decisions about the effect of different interventions but randomisation does not, of itself, promote the applicability of a trial's results to situations other than the precise one in which the trial was done. While methodologists and trialists have rightly paid great attention to internal validity, much less has been given to applicability. This narrative review is aimed at those planning to conduct trials, and those aimi...

  16. The L'Aquila trial

    Science.gov (United States)

    Amato, Alessandro; Cocco, Massimo; Cultrera, Giovanna; Galadini, Fabrizio; Margheriti, Lucia; Nostro, Concetta; Pantosti, Daniela

    2013-04-01

    The first step of the trial in L'Aquila (Italy) ended with a conviction of a group of seven experts to 6 years of jail and several million euros refund for the families of the people who died during the Mw 6.3 earthquake on April 6, 2009. This verdict has a tremendous impact on the scientific community as well as on the way in which scientists deliver their expert opinions to decision makers and society. In this presentation, we describe the role of scientists in charge of releasing authoritative information concerning earthquakes and seismic hazard and the conditions that led to the verdict, in order to discuss whether this trial represented a prosecution to science, and if errors were made in communicating the risk. Documents, articles and comments about the trial are collected in the web site http://processoaquila.wordpress.com/. We will first summarize what was the knowledge about the seismic hazard of the region and the vulnerability of L'Aquila before the meeting of the National Commission for Forecasting and Predicting Great Risks (CGR) held 6 days before the main shock. The basic point of the accusation is that the CGR suggested that no strong earthquake would have occurred (which of course was never mentioned by any seismologist participating to the meeting). This message would have convinced the victims to stay at home, instead of moving out after the M3.9 and M3.5 earthquakes few hours before the mainshock. We will describe how the available scientific information was passed to the national and local authorities, and in general how the Italian scientific Institution in charge of seismic monitoring and research (INGV), the Civil Protection Department (DPC) and the CGR should interact according to the law. As far as the communication and outreach to the public, the scientific Institutions as INGV have the duty to communicate scientific information. Instead, the risk management and the definition of actions for risk reduction is in charge of Civil

  17. Lessons learned from benchmark orthopaedic trials.

    Science.gov (United States)

    Swiontkowski, Marc F; Agel, Julie

    2012-07-18

    Benchmark trials in orthopaedics are designed to address a question of substantial interest to clinicians and patients. They are also designed to have prospective data collection, an adequate sample size, an appropriate duration of follow-up based on the injury or treatment under study, blinded adjudication of the outcome variables, appropriate statistical analyses, and widespread and effective dissemination of the information learned in the trial. There are multiple lessons to be gleaned from these trials: (1) Identifying an engaging and relevant clinical question will make it easier to identify centers that are willing to participate. (2) Individual site leadership, both of the overall project and at the individual site, is critical to the success of any trial. (3) Not every trial needs to have a randomized design; observational trials can provide data that will impact clinical care. (4) Patients should understand the long-term goals of the project when they are enrolled so that they have a sense of the importance of their role in the study. (5) Follow-up rates that are >90% are possible for orthopaedic trials, but effort and money are required to achieve this. (6) Patients who do not agree to be randomized should be enrolled as subjects in a parallel observational design if it is available. (7) Blinded adjudication of the outcome variables is recommended whenever feasible. (8) Partnership with the academic community is mandatory for the success of industry-funded, phase-3 United States Food and Drug Administration trials. (9) Intention-to-treat analysis and as-treated analysis should be reported. Benchmark orthopaedic trials can and will change clinical practice, but detailed planning must occur to ensure that the results are believable and relevant to the orthopaedic community. These trials are time-consuming and expensive, but with the use of careful initial planning and continued oversight during the trial, Level-I evidence will be obtained and will be useful

  18. A Public Trial De Novo

    DEFF Research Database (Denmark)

    Vedel, Jane Bjørn; Gad, Christopher

    2011-01-01

    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......” 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.” 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....

  19. 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....

  20. 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...

  1. The Child and Adolescent Psychiatry Trials Network

    Science.gov (United States)

    March, John S.; Silva, Susan G.; Compton, Scott; Anthony, Ginger; DeVeaugh-Geiss, Joseph; Califf, Robert; Krishnan, Ranga

    2004-01-01

    Objective: The current generation of clinical trials in pediatric psychiatry often fails to maximize clinical utility for practicing clinicians, thereby diluting its impact. Method: To attain maximum clinical relevance and acceptability, the Child and Adolescent Psychiatry Trials Network (CAPTN) will transport to pediatric psychiatry the practical…

  2. 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.

  3. Homo Economicus and the Salem Witch Trials.

    Science.gov (United States)

    Mixon, Franklin G., Jr.

    2000-01-01

    Provides background information on the Salem Witch Trials (Salem, Massachusetts) and the medical explanation of the young village girls' behavior in Salem called ergotism (bread poisoning). Presents an economic interpretation of those trials, stating that the ministers employed religious beliefs about witchcraft to maintain their churchs' monopoly…

  4. Recruitment, Retention, and Blinding in Clinical Trials

    OpenAIRE

    Page, Stephen J.; Persch, Andrew C.

    2013-01-01

    The recruitment and retention of participants and the blinding of participants, health care providers, and data collectors present challenges for clinical trial investigators. This article reviews challenges and alternative strategies associated with these three important clinical trial activities. Common recruiting pitfalls, including low sample size, unfriendly study designs, suboptimal testing locations, and untimely recruitment are discussed together with strategies for overcoming these b...

  5. Controversy, Trials, and Crime--Oh My!

    Science.gov (United States)

    Rott, Kim

    2006-01-01

    Teenagers' innate interest with the justice system is one of the reasons that so many high school literary classics teem with criminals, controversial issues, and trials. Novels such as "To Kill a Mockingbird," "A Separate Peace," "The Crucible," and "Twelve Angry Men" feature high-impact trials. In the author's desire to tap into this interest,…

  6. 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.

  7. Randomization in clinical trials: conclusions and recommendations.

    Science.gov (United States)

    Lachin, J M; Matts, J P; Wei, L J

    1988-12-01

    The statistical properties of simple (complete) randomization, permuted-block (or simply blocked) randomization, and the urn adaptive biased-coin randomization are summarized. These procedures are contrasted to covariate adaptive procedures such as minimization and to response adaptive procedures such as the play-the-winner rule. General recommendations are offered regarding the use of complete, permuted-block, or urn randomization. In a large double-masked trial, any of these procedures may be acceptable. For a given trial, the relative merits of each procedure should be carefully weighed in relation to the characteristics of the trial. Important considerations are the size of the trial, overall as well as within the smallest subgroup to be employed in a subgroup-specific analysis, whether or not the trial is to be masked, and the resources needed to perform the proper randomization-based permutational analysis. PMID:3203526

  8. Why are clinical trials necessary in India?

    Science.gov (United States)

    Poongothai, Subramani; Unnikrishnan, Ranjit; Balasubramanian, Jeyakumar; Nair, Mohan Damodaran; Mohan, Viswanathan

    2014-01-01

    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. PMID:24741480

  9. 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.

  10. 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.

  11. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  12. Design and analyses of clinical trials

    International Nuclear Information System (INIS)

    The course will use RTOG studies to illustrate design and analysis issues for phase I, phase II, and phase III trials. The issues discussed will include types of statistical errors, the selection of study endpoints, choice of the appropriate study population, determination of sample sizes, randomization, and plans for statistical analyses. Estimation of the sample sizes will be discussed for both absolute survival (alive or dead) and cause specific failure (local failure). For phase III trials, Data Monitoring Committees are now widely used in multi-centered trials. Their main purpose is to determine if there are sufficient evidence to terminate a study for efficacy or safety reasons. The results of two such terminated trials will be used to illustrate the DMC's function. The question of when should a trial be reported at medical meeting and in the literature will be explored. The emphasis will be on concepts and statistical notations will be kept to a minimum

  13. Obtaining evidence by a single well-powered trial or several modestly powered trials.

    Science.gov (United States)

    IntHout, Joanna; Ioannidis, John Pa; Borm, George F

    2016-04-01

    There is debate whether clinical trials with suboptimal power are justified and whether results from large studies are more reliable than the (combined) results of smaller trials. We quantified the error rates for evaluations based on single conventionally powered trials (80% or 90% power) versus evaluations based on the random-effects meta-analysis of a series of smaller trials. When a treatment was assumed to have no effect but heterogeneity was present, the error rates for a single trial were increased more than 10-fold above the nominal rate, even for low heterogeneity. Conversely, for meta-analyses on a series of trials, the error rates were correct. When selective publication was present, the error rates were always increased, but they still tended to be lower for a series of trials than single trials. We conclude that evidence of efficacy based on a series of (smaller) trials, may lower the error rates compared with using a single well-powered trial. Only when both heterogeneity and selective publication can be excluded, a single trial is able to provide conclusive evidence. PMID:23070590

  14. Efficacy, effectiveness, and behavior change trials in exercise research

    OpenAIRE

    Courneya Kerry S

    2010-01-01

    Abstract Background The widespread incorporation of behavioral support interventions into exercise trials has sometimes caused confusion concerning the primary purpose of a trial. The purpose of the present paper is to offer some conceptual and methodological distinctions among three types of exercise trials with a view towards improving their design, conduct, reporting, and interpretation. Discussion Exercise trials can be divided into "health outcome trials" or "behavior change trials" base...

  15. 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....

  16. The Cooperative Landscape of Multinational Clinical Trials.

    Science.gov (United States)

    Hsiehchen, David; Espinoza, Magdalena; Hsieh, Antony

    2015-01-01

    The scale and nature of cooperative efforts spanning geopolitical borders in clinical research have not been elucidated to date. In a cross-sectional study of 110,428 interventional trials registered in Clinicaltrials.gov, we characterized the evolution, trial demographics, and network properties of multinational clinical research. We reveal that the relative growth of international collaboratives has remained stagnant in the last two decades, although clinical trials have evolved to become much larger in scale. Multinational clinical trials are also characterized by higher patient enrollments, industry funding, and specific clinical disciplines including oncology and infectious disease. Network analyses demonstrate temporal shifts in collaboration patterns between countries and world regions, with developing nations now collaborating more within themselves, although Europe remains the dominant contributor to multinational clinical trials worldwide. Performances in network centrality measures also highlight the differential contribution of nations in the global research network. A city-level clinical trial network analysis further demonstrates how collaborative ties decline with physical distance. This study clarifies evolving themes and highlights potential growth mechanisms and barriers in multinational clinical trials, which may be useful in evaluating the role of national and local policies in organizing transborder efforts in clinical endeavors. PMID:26103155

  17. Barriers to Recruitment of Rural Patients in Cancer Clinical Trials

    OpenAIRE

    Virani, Shamsuddin; Burke, Lola; Remick, Scot C.; Abraham, Jame

    2011-01-01

    Rates of clinical trial participation are lower among patients in rural areas. Oncologists should be trained to address patient concerns regarding clinical trial availability, utility, and accessibility.

  18. Biomarkers for Alzheimer's disease therapeutic trials.

    Science.gov (United States)

    Hampel, Harald; Wilcock, Gordon; Andrieu, Sandrine; Aisen, Paul; Blennow, Kaj; Broich, K; Carrillo, Maria; Fox, Nick C; Frisoni, Giovanni B; Isaac, Maria; Lovestone, Simon; Nordberg, Agneta; Prvulovic, David; Sampaio, Christina; Scheltens, Philip; Weiner, Michael; Winblad, Bengt; Coley, Nicola; Vellas, Bruno

    2011-12-01

    The development of disease-modifying treatments for Alzheimer's disease requires innovative trials with large numbers of subjects and long observation periods. The use of blood, cerebrospinal fluid or neuroimaging biomarkers is critical for the demonstration of disease-modifying therapy effects on the brain. Suitable biomarkers are those which reflect the progression of AD related molecular mechanisms and neuropathology, including amyloidogenic processing and aggregation, hyperphosphorylation, accumulation of tau and neurofibrillary tangles, progressive functional, metabolic and structural decline, leading to neurodegeneration, loss of brain tissue and cognitive symptoms. Biomarkers should be used throughout clinical trial phases I-III of AD drug development. They can be used to enhance inclusion and exclusion criteria, or as baseline predictors to increase the statistical power of trials. Validated and qualified biomarkers may be used as outcome measures to detect treatment effects in pivotal clinical trials. Finally, biomarkers can be used to identify adverse effects. Questions regarding which biomarkers should be used in clinical trials, and how, are currently far from resolved. The Oxford Task Force continues and expands the work of our previous international expert task forces on disease-modifying trials and on endpoints for Alzheimer's disease clinical trials. The aim of this initiative was to bring together a selected number of key international opinion leaders and experts from academia, regulatory agencies and industry to condense the current knowledge and state of the art regarding the best use of biological markers in Alzheimer's disease therapy trials and to propose practical recommendations for the planning of future AD trials. PMID:21130138

  19. Eosinophilic esophagitis: trials and tribulations.

    Science.gov (United States)

    Allen, Katrina J; Heine, Ralf G

    2011-08-01

    Eosinophilic esophagitis (EE) is a recently recognized form of pan-esophagitis, which is characterized by the presence of at least 15 eosinophils per high power field on esophageal histology. EE is closely associated with atopic disorders and occurs predominantly in male patients. Young children are more likely to be sensitized to food allergens whilst aeroallergen sensitization predominates in older children and adults--a pattern reminiscent of the "atopic march". EE presents with a diverse range of gastrointestinal symptoms, including regurgitation, vomiting, feeding difficulties or refusal in infancy, in addition to dysphagia and food bolus impaction in older children and adults. The diagnosis may also be ascertained incidentally in patients undergoing gastroscopy for other suspected gastrointestinal conditions, such as gastroesophageal reflux disease or celiac disease. Complications mainly relate to subepithelial remodeling and fibrosis which may result in dysmotility, dysphagia and esophageal strictures. The proportion of EE patients at risk of these complications is unknown due to a paucity of data on the natural history of EE. There are only few randomized controlled trials assessing the efficacy of treatment modalities for EE, which currently either involve food allergen elimination or use of swallowed aerosolized corticosteroids. This article aims to discuss the complex issues of the diagnosis and long-term management that confront clinicians who care for children with EE. PMID:21415771

  20. Field trials at Bikini Atoll

    International Nuclear Information System (INIS)

    Last year's report summarized the status of both the long on-going soil and plant sampling programs (initiated by LLNL in 1978) and the field experiments aimed at reducing radionuclide levels in food plants to acceptable levels. In the current report the two are combined into a single summary table, indicating for each field trial or survey the results to date, information expected by the spring of 1988, and projection, if any, for continuation beyond FY1988. This table is therefore a comprehensive survey of the program and accordingly the individual items in it have been coded to facilitate reference to them. Analytical results from field studies installed in 1985 and 1986 are now providing much new information, briefly described below. In part, these results bear out or enlarge the hypotheses that prompted the studies. They also suggest how some treatments may be modified or combined for greater effectiveness. We shall discuss here certain groups of studies of immediate interest that deal with the blocking effects of potassium and other ions on cesium-137 uptake by plants, the effect of removing topsoil (excavation), cultural studies which involve the manipulation of the subsoil, plus some others

  1. 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.

  2. 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. PMID:25065958

  3. 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

  4. African HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North American trials.

    OpenAIRE

    Nandi Siegfried; Michael Clarke; Jimmy Volmink; Lize Van der Merwe

    2008-01-01

    BACKGROUND: Adherence to good methodological quality is necessary to minimise bias in randomised conrolled trials (RCTs). Specific trial characteristics are associated with better trial quality, but no studies to date are specific to HIV/AIDS or African trials. We postulated that location may negatively impact on trial quality in regions where resources are scarce. METHODS: 1) To compare the methodological quality of all HIV/AIDS RCTs conducted in Africa with a random sample of similar trials...

  5. A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov

    OpenAIRE

    Bell, Stuart A; Tudur Smith, Catrin

    2014-01-01

    Objectives To provide a comprehensive characterisation of rare disease clinical trials registered in ClinicalTrials.gov, and compare against characteristics of trials in non-rare diseases. Design Registry based study of ClinicalTrials.gov registration entries. Methods The ClinicalTrials.gov registry comprised 133,128 studies registered to September 27, 2012. By annotating medical subject heading descriptors to condition terms we could identify rare and non-rare disease trials. A total of 24,0...

  6. Efficacy, effectiveness, and behavior change trials in exercise research

    Directory of Open Access Journals (Sweden)

    Courneya Kerry S

    2010-11-01

    Full Text Available Abstract Background The widespread incorporation of behavioral support interventions into exercise trials has sometimes caused confusion concerning the primary purpose of a trial. The purpose of the present paper is to offer some conceptual and methodological distinctions among three types of exercise trials with a view towards improving their design, conduct, reporting, and interpretation. Discussion Exercise trials can be divided into "health outcome trials" or "behavior change trials" based on their primary outcome. Health outcome trials can be further divided into efficacy and effectiveness trials based on their potential for dissemination into practice. Exercise efficacy trials may achieve high levels of exercise adherence by supervising the exercise over a short intervention period ("traditional" exercise efficacy trials or by the adoption of an extensive behavioral support intervention designed to accommodate unsupervised exercise and/or an extended intervention period ("contemporary" exercise efficacy trials. Exercise effectiveness trials may emanate from the desire to test exercise interventions with proven efficacy ("traditional" exercise effectiveness trials or the desire to test behavioral support interventions with proven feasibility ("contemporary" exercise effectiveness trials. Efficacy, effectiveness, and behavior change trials often differ in terms of their primary and secondary outcomes, theoretical models adopted, selection of participants, nature of the exercise and comparison interventions, nature of the behavioral support intervention, sample size calculation, and interpretation of trial results. Summary Exercise researchers are encouraged to clarify the primary purpose of their trial to facilitate its design, conduct, and interpretation.

  7. Single Institution Feasibility Trials - Cancer Imaging Program

    Science.gov (United States)

    Within the CIP program, the current R21 mechanism provides potential funding for small, single institution feasibility trials. The current announcement is titled In Vivo Cancer Imaging Exploratory/Developmental Grants.

  8. 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 and...

  9. 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

  10. Survival in prostate cancer prevention trial detailed

    Science.gov (United States)

    In the NCI-sponsored Prostate Cancer Prevention Trial, initial findings from a decade ago showed that the drug finasteride significantly reduced the risk of prostate cancer, but among those who did develop prostate cancer, paradoxically, the drug was asso

  11. 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.

  12. 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...

  13. Problems for clinical trial with fast neutrons

    International Nuclear Information System (INIS)

    It has been confirmed through a clinical trial that the local control rate for radioresistant tumors or locally advanced tumors would be improved by applying such a high LET radiations. The treatment policy for various diseases candidated to this trial has reached an agreement among the oncologists. On the other hand, there were some problems to promote fast neutron therapy. These were as follows. (a) Evaluation of late effects of the normal tissues in the relation with local control of the tumors. (b) Promotion of a randomized clinical trial for accurate evaluation of the results. (c) Development of a system for high LET radiation therapy, including distribution of the machines. From this trial, improvement of the dose distribution for fast neutrons was urgently recommended in order to apply the special features of high LET radiations in radiotherapy. (author)

  14. Importance of Children in Clinical Trials

    Science.gov (United States)

    ... the time. Can we predict which drugs work differently in adults and children? No. The differences in ... to participate in a clinical trial, you should learn the key facts about it. To help you ...

  15. 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...

  16. Recruitment to publicly funded trials — Are surgical trials really different?

    OpenAIRE

    Cook, Jonathan A; Ramsay, Craig R; Norrie, John

    2008-01-01

    Background Good recruitment is integral to the conduct of a high-quality randomised controlled trial. It has been suggested that recruitment is particularly difficult for evaluations of surgical interventions, a field in which there is a dearth of evidence from randomised comparisons. While there is anecdotal speculation to support the inference that recruitment to surgical trials is more challenging than for medical trials we are unaware of any formal assessment of this. In this paper, we co...

  17. Formative research in clinical trial development: attitudes of patients with arthritis in enhancing prevention trials

    OpenAIRE

    Taylor, Holly A.; Sugarman, Jeremy; Pisetsky, David S; Bathon, Joan

    2007-01-01

    In preparation for randomised controlled trials (RCTs) of disease‐modifying antirheumatic drugs in patients with early inflammatory arthritis (EIA), formative research was conducted to enhance the design of such trials. The objectives of this research were to (1) determine patients' educational needs as they relate to the necessary elements of informed consent; and (2) assess patients' interest in enrolling in a hypothetical prevention trial. In‐depth interviews were conducted with nine patie...

  18. Barriers to recruitment for surgical trials in head and neck oncology: a survey of trial investigators

    OpenAIRE

    Kaur, Geetinder; Hutchison, Iain; Mehanna, Hisham; Williamson, Paula; Shaw, Richard; Tudur Smith, Catrin

    2013-01-01

    Objectives Many randomised trials in surgery suffer from recruitment rates that lag behind projected targets. We aim to identify perceived barriers to recruitment among these pioneering trials in the field of head and neck cancer surgery. Design Recruiting centres to all three trials (Selective Elective Neck Dissection (SEND), Positron Emission Tomography (PET)-Neck and Hyperbaric Oxygen in the Prevention of Osteoradionecrosis (HOPON)) were contacted by email by the chief investigators. Respo...

  19. Randomization in substance abuse clinical trials

    OpenAIRE

    Woolson Robert F; Hedden Sarra L; Malcolm Robert J

    2006-01-01

    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 distribu...

  20. Midwest Vegetable Trial Report for 2015

    OpenAIRE

    Maynard, Elizabeth

    2016-01-01

    This is a compilation of 19 research trial reports from six land-grant universities in the midwestern United States. Crops include bok choy, cantaloupe, cucumber, pepper, pumpkin, sweet corn, squash, tomato, and watermelon. Several crops were evaluated in high tunnels or hoophouses. Most trials evaluated different cultivars or varieties, including one investigating cantaloupe variety influence on cucumber beetle presence and incidence of bacterial wilt. Four reports addressed specific growing...

  1. Consumers’ Trial Buying Process of Service Innovation.

    OpenAIRE

    Peltonen, Laura

    2013-01-01

    The aim of this thesis was to investigate and give a deeper understanding of consumers’ trial buying process of a service innovation in an online environment. More specifically, this thesis tries to clarify the connection between consumers’ adoption decisions, external influences and the service experience of an innovation in an online environment. A trial buying process was studied in order to increase the case company HOK-Elanto’s knowledge of how their customers make adoption decisions whe...

  2. 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.

  3. Reference bias in reports of drug trials.

    OpenAIRE

    Dickersin, K

    1987-01-01

    Articles published before 1985 describing double blind trials of two or more non-steroidal anti-inflammatory drugs in rheumatoid arthritis were examined to see whether there was any bias in the references they cited. Althogether 244 articles meeting the criteria were found through a Medline search and through examining the reference lists of the articles retrieved. The drugs compared in the studies were classified as new or as control drugs and the outcome of the trial as positive or not posi...

  4. Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials

    Directory of Open Access Journals (Sweden)

    Delaney Brendan

    2010-04-01

    Full Text Available Abstract Background Trials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternative methods using a randomized trial, 'nested' in an ongoing 'host' trial. There are potential scientific, logistical and ethical obstacles to such studies. Methods Telephone interviews were undertaken with four groups of stakeholders (funders, principal investigators, trial managers and ethics committee chairs to explore their views on the practicality and acceptability of undertaking nested trials of recruitment methods. These semi-structured interviews were transcribed and analysed thematically. Results Twenty people were interviewed. Respondents were familiar with recruitment difficulties in primary care and recognised the case for 'nested' studies to build an evidence base on effective recruitment strategies. However, enthusiasm for this global aim was tempered by the challenges of implementation. Challenges for host studies included increasing complexity and management burden; compatibility between the host and nested study; and the impact of the nested study on trial design and relationships with collaborators. For nested recruitment studies, there were concerns that host study investigators might have strong preferences, limiting the nested study investigators' control over their research, and also concerns about sample size which might limit statistical power. Nested studies needed to be compatible with the main trial and should be planned from the outset. Good communication and adequate resources were seen as important. Conclusions Although research on recruitment was welcomed in principle, the issue of which study had control of key decisions emerged as critical. To address this concern, it appeared important to align the interests of both host and nested studies and to reduce the burden of hosting a recruitment trial. These

  5. 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....

  6. Marketing and clinical trials: a case study

    OpenAIRE

    Entwistle Vikki A; Snowdon Claire; Garcia Jo; Knight Rosemary C; Shakur Haleema; Elbourne Diana R; Roberts Ian; Francis David; McDonald Alison M; Grant Adrian M; Campbell Marion K

    2007-01-01

    Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, o...

  7. Relational Dynamics in Perception: Impacts on trial-to-trial variation

    Directory of Open Access Journals (Sweden)

    Shimon Marom

    2011-04-01

    Full Text Available We show that trial-to-trial variability in sensory detection of a weak visual stimulus is dramatically diminished when rather than presenting a fixed stimulus contrast, fluctuations in a subject's judgment are matched by fluctuations in stimulus contrast. This attenuation of fluctuations does not involve a change in the subject's psychometric function. The result is consistent with the interpretation of trial-to-trial variability in this sensory detection task being a high-level meta-cognitive control process that explores for something that our brains are so used to: subject-object relational dynamics.

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

    International Nuclear Information System (INIS)

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. 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, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  9. 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.

  10. 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....

  11. A Quality Analysis of Randomized Controlled Trials about Erectile Dysfunction

    OpenAIRE

    Chung, Jae Hoon; Lee, Jeong Woo; Jo, Jung Ki; Kim, Kyu Shik; Lee, Seung Wook

    2013-01-01

    Purpose A low quality clinical trial could produce errors, and these errors could, in turn, distort the results of the clinical trial. To avoid applying distorted results of trials clinically, a quality analysis of clinical trials is needed. Materials and Methods We selected randomized controlled trials (RCTs) about erectile dysfunction (ED) conducted in Korea using Medline and KoreaMed. Quality assessment of selected RCTs was performed using three assessment tools (Jadad scales, van Tulder s...

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

    OpenAIRE

    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 drug development. This thesis focuses on three important aspects of clinical trials in depression: clinical endpoints, data analysis and trial design-related factors.

  13. 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

  14. Mind the gap: An empirical study of post-trial access in HIV biomedical prevention trials.

    Science.gov (United States)

    Haire, Bridget; Jordens, Christopher

    2015-08-01

    The principle of providing post-trial access for research participants to successful products of that research is widely accepted and has been enshrined in various declarations and guidelines. While recent ethical guidelines recognise that the responsibility to provide post-trial access extends to sponsors, regulators and government bodies as well as to researchers, it is the researchers who have the direct duty of care to participants. Researchers may thus need to act as advocates for trial participants, especially where government bodies, sponsors, and regulatory bodies have complex interests vested in decisions about whether or not new interventions are made available, how, and to whom. This paper provides an empirical account of post-trial access in the context of HIV prevention research. It describes both access to the successful products of research and the provision antiretroviral drugs for trial participants who acquire HIV. First, we provide evidence that, in the current system, there is considerable variation in the duration and timeliness of access. We then argue that by analysing the difficulties faced by researchers to this point, and their efforts to meet this obligation, much can be learned about how to secure post-trial access in HIV biomedical preventions trials. While researchers alone have a limited obligation, their advocacy on behalf of trial participants may be necessary to call the other parties to account. PMID:26193849

  15. Rape Trial Coverage on Trial: The Myth, the Reality, the Result.

    Science.gov (United States)

    Drucker, Susan J.; Hunold, Janice Platt

    Coverage of the New Bedford Massachusetts "Big Dan's Tavern Rape Trial" by Cable News Network (CNN) television cameras was ostensibly for educational purposes, to examine how rape victims are treated in court and how the judicial process works in general. However, the sensational nature of the trial strongly suggests that it was televised only to…

  16. Quality of clinical trials: A moving target

    Directory of Open Access Journals (Sweden)

    Arun Bhatt

    2011-01-01

    Full Text Available Quality of clinical trials depends on data integrity and subject protection. Globalization, outsourcing and increasing complexicity of clinical trials have made the target of achieving global quality challenging. The quality, as judged by regulatory inspections of the investigator sites, sponsors/contract research organizations and Institutional Review Board, has been of concern to the US Food and Drug Administration, as there has been hardly any change in frequency and nature of common deficiencies. To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include: personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention, and reporting and corrective and preventive action. With an objective to improve quality, the FDA has planned new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems. The FDA has partnered with Duke University for Clinical Trials Transformation Initiative, which will conduct research projects on design principles, data quality and quantity including monitoring, study start-up, and adverse event reporting. These recent initiatives will go a long way in improving quality of clinical trials.

  17. 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.

  18. 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...

  19. 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. PMID:8856824

  20. The future of neonatal therapeutic trials.

    Science.gov (United States)

    Stephenson, T; Budge, H

    2006-07-01

    Neonatology has undoubtedly benefited from clinical trials. Nevertheless, more treatments based on inadequate experimental evidence are given than those that are supported by a validated evidence base. Clinicians seeking the basis for their current and future clinical practice are faced with challenges in the shadow of recent UK legislation and government recommendations. All patients must be protected from inappropriate research, but the benefits of regulations must be appropriately balanced with those of properly conducted clinical trials. It is ethically difficult both to persist with treatments of unproven benefit and unknown harm and to deny infants potentially valuable therapies. It is important that trials are conducted within the new legislative framework, but their future may rest with innovative solutions and the determination of all involved in the process. PMID:16790737

  1. 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.

  2. 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 and...... social actors besides those on trial. Viewing corruption as the thematic focus of the media texts, this wider scope of enquiry into the mensalão affair allows us to see that media, political actors and institutions use cases of corruption for much more than mere condemnation of transgressions: The...

  3. 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

  4. Therapeutic trials in digital osteoarthritis. A critical review.

    Science.gov (United States)

    Trêves, R; Maheu, E; Dreiser, R L

    1995-06-01

    Although common, hand osteoarthritis is controversial and rarely used as a model for clinical trials in osteoarthritis. We found only 13 therapeutic trials conducted in digital or trapeziometacarpal osteoarthritis between 1983 and 1994. Eleven of these trials were published. Seven were on nonsteroidal antiinflammatory drugs given either per os (two trials, meclofenamate and ibuprofen) or percutaneously (one trial each on etofenamate, ibuprofen, and ketoprofen gel, and two trials on niflumic acid gel), three were on symptomatic slow-acting drugs (glycosaminoglycanes in two trials and chondroitin sulfate in one), and three were on miscellaneous agents (the muscle relaxant idrocilamide, as a gel; the antisubstance P agent capsaicin, also as a gel; and a spa treatment). We have reviewed the methodology and findings of these trials with the goal of determining the optimal approach to realize better standardized trials in the next future for identifying symptomatic slow-acting drugs and/or "chondroprotective" agents with beneficial effects in digital osteoarthritis. PMID:7583181

  5. 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...

  6. 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.

  7. Crowd psychology in South African murder trials.

    Science.gov (United States)

    Colman, A M

    1991-10-01

    South African courts have recently accepted social psychological phenomena as extenuating factors in murder trials. In one important case, eight railway workers were convicted of murdering four strike breakers during an industrial dispute. The court accepted conformity, obedience, group polarization, deindividuation, bystander apathy, and other well-established psychological phenomena as extenuating factors for four of the eight defendants, but sentenced the others to death. In a second trial, death sentences of five defendants for the "necklace" killing of a young woman were reduced to 20 months imprisonment in the light of similar social psychological evidence. Practical and ethical issues arising from expert psychological testimony are discussed. PMID:1746773

  8. 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.

  9. General pretrial publicity in sexual assault trials.

    Science.gov (United States)

    Woody, William Douglas; Viney, Wayne

    2007-10-01

    An experiment was designed to explore effects of general pretrial publicity in sexual assault trials. Four pretrial publicity conditions (no publicity, neutral news media, prodefendant, and antidefendant) in the form of simulated newspaper articles were presented to 356 participants. Participants subsequently read a mock rape trial summary and reported verdicts. In the absence of pretrial publicity related to sexual assault, women were more likely than men to convict the defendant, but the presence of sexual assault pretrial publicity in any form eliminated sex differences in conviction rates. PMID:18175495

  10. 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. PMID:25904313

  11. 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.

  12. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units

    Directory of Open Access Journals (Sweden)

    Russell Ian T

    2008-11-01

    Full Text Available Abstract Background There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC does not require a standard operating procedure (SOP for economic evaluation as a prerequisite for trial unit registration. We judge that such a SOP facilitates the integration of health economics into trials. Methods A collaboration between health economists and trialists at Bangor University led to the development of a SOP for economic evaluation alongside pragmatic trials, in addition to the twenty SOPs required by UKCRC for registration, which include randomisation, data management and statistical analysis. Results Our recent telephone survey suggests that no other UKCRC-registered trials unit currently has an economic SOP. Conclusion We argue that UKCRC should require, from all Trials Units undertaking economic evaluation and seeking registration or re-registration, a SOP for economic evaluation as one of their portfolio of supporting SOPs.

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

    Science.gov (United States)

    de Xivry J-J, Orban; de Xivry, Jean-Jacques Orban

    2013-01-01

    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. PMID:23776593

  14. Chelation therapy after the Trial to Assess Chelation Therapy: results of a unique trial

    OpenAIRE

    Maria D. Avila; Escolar, Esteban; Lamas, Gervasio A.

    2014-01-01

    Purpose of review EDTA chelation therapy has been in off-label use for the treatment of atherosclerosis. We review the results of the first large-scale randomized trial of this treatment. Recent findings The trial to assess chelation therapy was a $30 million National Institutes of Health-funded study of the safety and efficacy of EDTA-based chelation infusions in 1708 post-myocardial infarction (MI) patients. The trial to assess chelation therapy demonstrated a significant (P = 0.035) 18% re...

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

    OpenAIRE

    Lois Biener; Eunyoung Song; Sutfin, Erin L.; John Spangler; Mark Wolfson

    2015-01-01

    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 ...

  16. Stroke Prevention Trials in Sickle Cell Anemia

    OpenAIRE

    J Gordon Millichap

    2006-01-01

    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.

  17. Applied Behavior Analysis: Beyond Discrete Trial Teaching

    Science.gov (United States)

    Steege, Mark W.; Mace, F. Charles; Perry, Lora; Longenecker, Harold

    2007-01-01

    We discuss the problem of autism-specific special education programs representing themselves as Applied Behavior Analysis (ABA) programs when the only ABA intervention employed is Discrete Trial Teaching (DTT), and often for limited portions of the school day. Although DTT has many advantages to recommend its use, it is not well suited to teach…

  18. Ethical issues in postauthorization drug trials

    NARCIS (Netherlands)

    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 con

  19. Cluster Randomized Trials with Treatment Noncompliance

    Science.gov (United States)

    Jo, Booil; Asparouhov, Tihomir; Muthen, Bengt O.; Ialongo, Nicholas S.; Brown, C. Hendricks

    2008-01-01

    Cluster randomized trials (CRTs) have been widely used in field experiments treating a cluster of individuals as the unit of randomization. This study focused particularly on situations where CRTs are accompanied by a common complication, namely, treatment noncompliance or, more generally, intervention nonadherence. In CRTs, compliance may be…

  20. 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.

  1. Clinical Trials in Male Hormonal Contraception

    OpenAIRE

    Nieschlag E

    2011-01-01

    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 depo...

  2. Randomized controlled trials of COX-2 inhibitors

    DEFF Research Database (Denmark)

    Stefansdottir, Gudrun; De Bruin, Marie L; Knol, Mirjam J;

    2011-01-01

    BACKGROUND: Naproxen, ibuprofen and diclofenac are frequently used as comparators in randomized controlled trials (RCTs) on the safety and efficacy of cyclooxygenase (COX)-2 inhibitors. Different comparator doses may influence the results of RCTs. It has been hypothesized that RCTs of COX-2...

  3. Unit: Petroleum, 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 petroleum developed for the Australian Science Education Project. The package contains the teacher's edition of the written material and a script for a film entitled "The Extraordinary Experience of Nicholas Nodwell" emphasizing the uses of petroleum and petroleum products in daily life and designed to…

  4. 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.

  5. Blast densification trials for oilsands tailings

    Energy Technology Data Exchange (ETDEWEB)

    Port, A. [Klohn Crippen Berger Ltd., Vancouver, BC (Canada); Martens, S. [Klohn Crippen Berger Ltd., Calgary, AB (Canada); Eaton, T. [Shell Canada Ltd., Calgary, AB (Canada)

    2010-07-01

    The Shell Canada Muskeg River Mine External Tailings Facility (ETF) is an upstream constructed tailings facility located near Fort McMurray, Alberta. Raises have incrementally stepped out over the beach since construction of the starter dam and deposition within standing water has left some parts of the beach in a loose state. In order to assess the effectiveness of blast densification, a blast densification trial program that was conducted in 2006 at the ETF. The primary purpose of the test program was to determine the effectiveness of blast densification in tailings containing layers and zones of bitumen. The paper described the site characterization and explosive compaction trial program, with particular reference to test layout; drilling methodology; and blasting and timing sequence. The paper also described the instrumentation, including the seismographs; high pressure electric piezometers; low pressure electric piezometers; vibrating wire piezometers; inclinometers; settlement gauges; and surveys. Trial observations and post-trial observations were also presented. It was concluded that controlled blasting techniques could be used to safely induce liquefaction in localized areas within the tailings deposit, with a resulting increase in the tailings density. 5 refs., 1 tab., 14 figs.

  6. New EORTC clinical trials for BNCT

    International Nuclear Information System (INIS)

    Due to ethical reasons, a separated optimization of the two components of BNCT in the frame of clinical investigations can only be performed applying the whole binary system. The ongoing trial at HFR (High Flux Reactor Petten) has proven the feasibility of BNCT under defined conditions. On that basis the European Commission supported a comprehensive research project on boron imaging including three further clinical studies. In the first trial the boron uptake related to the blood boron concentration and surrounding normal tissue in various solid tumours will be examined using BSH (Sodiumborocaptate), BPA (Boronophenylalanine) or both in order to explore tumour entities, which may gain benefit from BNCT. The major objectives of the second trial are to define the maximum tolerated single and cumulative dose, and the dose limiting toxicity of BSH. The third clinical trial, a phase II study is designed to evaluate the anti-tumour effect of fractionated BNCT at the Petten treatment facility against cerebral metastasis of malignant melanoma using BPA. (author)

  7. Review of the optic neuritis treatment trial

    International Nuclear Information System (INIS)

    The Optic Neuritis Treatment Trial (ONTT) is a multicenter controlled clinical trial. The primary objective of this trial is to assess the efficacy of corticosteroids in the treatment of optic neuritis. Treatment with intravenous methylprednisolone resulted in a more rapid return of the visual function to normal. Oral prednisone alone was associated with a significantly increased risk of recurrent optic neuritis. The trial also provided invaluable information about the clinical profile of optic neuritis and its relationship to Multiple Sclerosis (MS). At 6 months after the initial optic neuritis attack, a 12-month follow-up of patients was begun and the data collected during this period indicated that visual acuity was more than 20/20 in 69%, 20/40 in 93%, and 20/200 or less in only 3% of the patients. The risk of MS within 10 years after the first episode of optic neuritis was 56% among patients who were found to have had one or more characteristic white-matter lesions at baseline, as compared to only 22% for patients who had no observable lesions at baseline. (author)

  8. Building data quality into clinical trials.

    Science.gov (United States)

    Crerand, William J; Lamb, Jana; Rulon, Vera; Karal, Bilun; Mardekian, Jack

    2002-01-01

    Meaningful data begin with the collection process. Pharmaceutical companies are using several different strategies in clinical trials to ensure the highest quality of data. This article will examine these approaches, with an emphasis on case report form development through database release. PMID:12432815

  9. 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

  10. Pipeline Decommissioning Trial AWE Berkshire UK - 13619

    Energy Technology Data Exchange (ETDEWEB)

    Agnew, Kieran [AWE, Aldermaston, Reading, RG7 4PR (United Kingdom)

    2013-07-01

    This Paper details the implementation of a 'Decommissioning Trial' to assess the feasibility of decommissioning the redundant pipeline operated by AWE located in Berkshire UK. The paper also presents the tool box of decommissioning techniques that were developed during the decommissioning trial. Constructed in the 1950's and operated until 2005, AWE used a pipeline for the authorised discharge of treated effluent. Now redundant, the pipeline is under a care and surveillance regime awaiting decommissioning. The pipeline is some 18.5 km in length and extends from AWE site to the River Thames. Along its route the pipeline passes along and under several major roads, railway lines and rivers as well as travelling through woodland, agricultural land and residential areas. Currently under care and surveillance AWE is considering a number of options for decommissioning the pipeline. One option is to remove the pipeline. In order to assist option evaluation and assess the feasibility of removing the pipeline a decommissioning trial was undertaken and sections of the pipeline were removed within the AWE site. The objectives of the decommissioning trial were to: - Demonstrate to stakeholders that the pipeline can be removed safely, securely and cleanly - Develop a 'tool box' of methods that could be deployed to remove the pipeline - Replicate the conditions and environments encountered along the route of the pipeline The onsite trial was also designed to replicate the physical prevailing conditions and constraints encountered along the remainder of its route i.e. working along a narrow corridor, working in close proximity to roads, working in proximity to above ground and underground services (e.g. Gas, Water, Electricity). By undertaking the decommissioning trial AWE have successfully demonstrated the pipeline can be decommissioned in a safe, secure and clean manor and have developed a tool box of decommissioning techniques. The tool box of includes

  11. Pipeline Decommissioning Trial AWE Berkshire UK - 13619

    International Nuclear Information System (INIS)

    This Paper details the implementation of a 'Decommissioning Trial' to assess the feasibility of decommissioning the redundant pipeline operated by AWE located in Berkshire UK. The paper also presents the tool box of decommissioning techniques that were developed during the decommissioning trial. Constructed in the 1950's and operated until 2005, AWE used a pipeline for the authorised discharge of treated effluent. Now redundant, the pipeline is under a care and surveillance regime awaiting decommissioning. The pipeline is some 18.5 km in length and extends from AWE site to the River Thames. Along its route the pipeline passes along and under several major roads, railway lines and rivers as well as travelling through woodland, agricultural land and residential areas. Currently under care and surveillance AWE is considering a number of options for decommissioning the pipeline. One option is to remove the pipeline. In order to assist option evaluation and assess the feasibility of removing the pipeline a decommissioning trial was undertaken and sections of the pipeline were removed within the AWE site. The objectives of the decommissioning trial were to: - Demonstrate to stakeholders that the pipeline can be removed safely, securely and cleanly - Develop a 'tool box' of methods that could be deployed to remove the pipeline - Replicate the conditions and environments encountered along the route of the pipeline The onsite trial was also designed to replicate the physical prevailing conditions and constraints encountered along the remainder of its route i.e. working along a narrow corridor, working in close proximity to roads, working in proximity to above ground and underground services (e.g. Gas, Water, Electricity). By undertaking the decommissioning trial AWE have successfully demonstrated the pipeline can be decommissioned in a safe, secure and clean manor and have developed a tool box of decommissioning techniques. The tool box of includes; - Hot tapping - a method

  12. The Radiation oncology practice standards trial

    International Nuclear Information System (INIS)

    Full text: In 2008 the Commonwealth Government approved funding of up to $1.4 million for radiation oncology practice standards (the standards) to be drafted, trialled, finalised and published. A Tripartite Standards Committee comprising representatives from the Royal Australian and New Zealand College of Radiologists (RANZCR), Australian Insti tute of Radiography (AIR) and Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) coordinated and managed the drafting of the standards. Following public consultation in September 2008, the draft standards were endorsed for trjalling by the Radiation Oncology Reform Implementation Committee (RORIC) of the Australian Health Ministers' Advisory Council (AHMAC). In June 2009 the National Association of Testing Authorities, Australia (NATA) was engaged by the Department of Health and Ageing to conduct a trial of the draft standards by collecting feedback on their implementability with a representative sample of radiation oncology facilities. The trial formally commenced in January 20 I 0 and data is being collected via an on-line questionnaire, follow up site visits and a focus group meeting. The results will be used to establish baseline data on compliance and to assess the costs of compliance. A steering committee comprising representatives from the Tripartite Standards Committee is assisting the Commonwealth to oversight the project. The standards trial is due for completion by the end of 20 I 0, subject to facilities completing all components of the trial in the required time. The outcomes of the trial will inform a revision of the standards by the Tripartite Standards Committee for finalisation and publication. At this time consideration will be given to the tools required by facilities to assist their longer term use within the sector. This may include how compliance with the standards might be assessed. This presentation will describe the process and findings to date and describe the next steps

  13. Prostate Cancer Research Trial Helps John Spencer Treat His Cancer

    Science.gov (United States)

    ... this page please turn Javascript on. Feature: Prostate Cancer Prostate Cancer Research Trial Helps John Spencer Treat His ... Read More "Prostate Cancer" Articles Progress Against Prostate Cancer / Prostate Cancer Research Trial Helps John Spencer Treat His ...

  14. Most Breast Cancer Screening Trials Have a Flawed Design

    OpenAIRE

    Gurnani, Nishant; Srivastava, Anurag

    2011-01-01

    In the present article, we discuss that why most breast cancer screening trials have a flawed origin. We suggest some solutions to correct these flaws so that more valid and reliable screening trials can be conducted in the future.

  15. Impact of the European Clinical Trials Directive on prospective academic clinical trials associated with BMT

    OpenAIRE

    Frewer, L. J.; Coles, D.; van der Lans, I A; Schroeder, D.; Champion, K.; Apperley, J. F.

    2010-01-01

    The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. F...

  16. Economic evaluation alongside pragmatic randomised trials: developing a standard operating procedure for clinical trials units

    OpenAIRE

    Russell Ian T; Linck Pat; Hounsome Barry; Edwards Rhiannon T

    2008-01-01

    Abstract Background There is wide recognition that pragmatic randomised trials are the best vehicle for economic evaluation. This is because trials provide the best chance of ensuring internal validity, not least through the rigorous prospective collection of patient-specific data. Furthermore the marginal cost of collecting economic data alongside clinical data is typically modest. UK Clinical Research Collaboration (UKCRC) does not require a standard operating procedure (SOP) for economic e...

  17. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

    OpenAIRE

    Rapport, F; Storey, M; Porter, A; Snooks, H.; Jones, K; Peconi, J.; Sanchez, A.; Siebert, S.; Thorn, K.; Clement, C.; Russell, I T

    2013-01-01

    BACKGROUND: Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influen...

  18. 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...

  19. Contribution of clinical trials to gross domestic product in Hungary

    OpenAIRE

    Kaló, Zoltán; Antal, János; Pénzes, Miklós; Pozsgay, Csilla; Szepezdi, Zsuzsanna; Nagyjánosi, László

    2014-01-01

    Aim To determine the contribution of clinical trials to the gross domestic product (GDP) in Hungary. Methods An anonymous survey of pharmaceutical companies and clinical research organizations (CROs) was conducted to estimate their clinical trial-related employment and revenues. Clinical trial documents at the National Institute of Pharmacy (NIP) were analyzed to estimate trial-related revenues at health care institutions and the value of investigational medical products (IMPs) based on avoid...

  20. 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.

  1. 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...

  2. Globally optimal trial design for local decision making.

    Science.gov (United States)

    Eckermann, Simon; Willan, Andrew R

    2009-02-01

    Value of information methods allows decision makers to identify efficient trial design following a principle of maximizing the expected value to decision makers of information from potential trial designs relative to their expected cost. However, in health technology assessment (HTA) the restrictive assumption has been made that, prospectively, there is only expected value of sample information from research commissioned within jurisdiction. This paper extends the framework for optimal trial design and decision making within jurisdiction to allow for optimal trial design across jurisdictions. This is illustrated in identifying an optimal trial design for decision making across the US, the UK and Australia for early versus late external cephalic version for pregnant women presenting in the breech position. The expected net gain from locally optimal trial designs of US$0.72M is shown to increase to US$1.14M with a globally optimal trial design. In general, the proposed method of globally optimal trial design improves on optimal trial design within jurisdictions by: (i) reflecting the global value of non-rival information; (ii) allowing optimal allocation of trial sample across jurisdictions; (iii) avoiding market failure associated with free-rider effects, sub-optimal spreading of fixed costs and heterogeneity of trial information with multiple trials. PMID:18435429

  3. Interim analysis in long-term clinical trials

    NARCIS (Netherlands)

    G.A. van Es (Gerrit Anne)

    1990-01-01

    textabstractThe purpose of this dissertation is to evaluate the usefulness of both stopping rules and estimation methods in long-term clinical trials with interim analyses. The ASPECT trial, a long-term clinical trial to assess the effect of anticoagulant therapy on mortality in patients after myoca

  4. 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

  5. 21 CFR 886.1405 - Ophthalmic trial lens set.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens set. 886.1405 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1405 Ophthalmic trial lens set. (a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric...

  6. 21 CFR 886.1410 - Ophthalmic trial lens clip.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens clip. 886.1410 Section 886...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1410 Ophthalmic trial lens clip. (a) Identification. An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders,...

  7. 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

    trials. Methods Randomised phase III trials on adult patients with gastrointestinal diseases registered before January 2009 in http://ClinicalTrials.gov were eligible for inclusion. From http://ClinicalTrials.gov all data elements in the database required by the International Committee of Medical Journal...... elements of the required ICMJE data list were not filled in, with missing data in 22% and 11%, respectively, of cases concerning the primary outcome measure and sample size. In 26% of the published papers, data on sample size calculations were missing and discrepancies between sample size reporting in http://ClinicalTrials......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...

  8. 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

  9. 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...

  10. Clinical Trial Results Vary Widely, But Always Advance Research | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials Clinical Trial Results Vary Widely, But Always Advance Research Past ... very emotional." Should You Be Interested in a Clinical Trial People volunteer to take part in clinical trials ...

  11. Designing Clinical Trials of Intervention for Mobility Disability: Results from the Lifestyle Interventions and Independence for Elders (LIFE) Pilot Trial

    Science.gov (United States)

    Clinical trials to assess interventions for mobility disability are critically needed, however data for efficiently designing such trials are lacking. Our results are described from the LIFE pilot clinical trial, in which 424 volunteers aged 70-89 years were randomly assigned to one of two intervent...

  12. 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.

  13. 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,...

  14. 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.

  15. Malaria vaccines: lessons from field trials

    Directory of Open Access Journals (Sweden)

    Struchiner Claudio J.

    1994-01-01

    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.

  16. 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.

  17. First clinical trial with iohexol in myelography

    International Nuclear Information System (INIS)

    This is a report of the first clinical trial with iohexol in lumbar myelography. The investigation was carried out as an open, non-comparative study in 30 patients and was part of a mulicentre trial. Iohexol doses of 10 to 15 ml (180 mg I/ml) were used and clinical and laboratory tests were performed before and during 48 h after myelography. Spinal repuncture 6 or 24 h after myelography was done in all patients. Only minor side effects of temporary duration were recorded in 8 patients. No seizures or spikes on EEG were seen. There was no significant increase in CSF parameters such as white cell counts, protein or IgG. (Auth.)

  18. Clinical trials of conformal therapy - physics aspects

    International Nuclear Information System (INIS)

    If Conformal Therapy (CFRT) hadn't existed, physicists would have invented it! So many of the concepts involved are physicist ones: 3-D dose calculation/planning, Beam's-Eye-View, Dose-Volume Histograms, Multileaf Collimators, Computer-Controlled Delivery, Megavoltage Imaging, Optimization, Inverse Planning, Tomotherapy, Biological Modeling, even Protons. All the above developments, many of them involving fairly expensive technology, are on trial. If we wish to be able to use and to continue development of these physicist tools in the future then it has to be demonstrated conclusively that CFRT results in improved clinical outcome. Physicists should therefore be in the front line of planning, executing and evaluating Clinical Trials of Conformal Therapy, by which I mean Randomized, Prospective Phase-III trials i.e. ones that have improved complication-free local control/survival as their endpoint. A prospective, randomized trial to assess the effect of reducing the volume of irradiated normal tissue on acute side-effects in pelvic radiotherapy (93% prostate or bladder ca.) has been carried out at our centre, on 266 patients. In both arms a 3-field, 6 MV x-ray technique was used with identical dose prescriptions; in the conventional arm rectangular fields were employed whereas in the conformal arm the fields were shaped with customized blocks drawn according to the Beam's-Eye-View of the target volume. Substantial differences in normal-tissue volumes (rectum, bladder etc.) were achieved: mean High-Dose Volume (∼ PTV) of 690 cm3 for the conformal technique vs 940 cm3 conventionally. Comprehensive quality-of-life questionnaire were completed before the start of treatment, weekly during and for 3 weeks after the end of treatment and then monthly for a further 2 months. A clear pattern of an increase during followed by a decrease after treatment in symptoms relating to bowel and bladder functions was observed for the patient group as a whole. However, a very extensive

  19. Coping with Trial-to-Trial Variability of Event Related Signals: A Bayesian Inference Approach

    Science.gov (United States)

    Ding, Mingzhou; Chen, Youghong; Knuth, Kevin H.; Bressler, Steven L.; Schroeder, Charles E.

    2005-01-01

    In electro-neurophysiology, single-trial brain responses to a sensory stimulus or a motor act are commonly assumed to result from the linear superposition of a stereotypic event-related signal (e.g. the event-related potential or ERP) that is invariant across trials and some ongoing brain activity often referred to as noise. To extract the signal, one performs an ensemble average of the brain responses over many identical trials to attenuate the noise. To date, h s simple signal-plus-noise (SPN) model has been the dominant approach in cognitive neuroscience. Mounting empirical evidence has shown that the assumptions underlying this model may be overly simplistic. More realistic models have been proposed that account for the trial-to-trial variability of the event-related signal as well as the possibility of multiple differentially varying components within a given ERP waveform. The variable-signal-plus-noise (VSPN) model, which has been demonstrated to provide the foundation for separation and characterization of multiple differentially varying components, has the potential to provide a rich source of information for questions related to neural functions that complement the SPN model. Thus, being able to estimate the amplitude and latency of each ERP component on a trial-by-trial basis provides a critical link between the perceived benefits of the VSPN model and its many concrete applications. In this paper we describe a Bayesian approach to deal with this issue and the resulting strategy is referred to as the differentially Variable Component Analysis (dVCA). We compare the performance of dVCA on simulated data with Independent Component Analysis (ICA) and analyze neurobiological recordings from monkeys performing cognitive tasks.

  20. The RAZOR (randomized open vs robotic cystectomy) trial: study design and trial update

    Science.gov (United States)

    Smith, Norm D.; Castle, Erik P.; Gonzalgo, Mark L.; Svatek, Robert S.; Weizer, Alon Z.; Montgomery, Jeffrey S.; Pruthi, Raj S.; Woods, Michael E.; Tollefson, Matthew K.; Konety, Badrinath R.; Shabsigh, Ahmad; Krupski, Tracey; Barocas, Daniel A.; Dash, Atreya; Quek, Marcus L.; Kibel, Adam S.; Parekh, Dipen J.

    2016-01-01

    The purpose of the RAZOR (randomized open vs robotic cystectomy) study is to compare open radical cystectomy (ORC) vs robot-assisted RC (RARC), pelvic lymph node dissection (PLND) and urinary diversion for oncological outcomes, complications and health-related quality of life (HRQL) measures with a primary endpoint of 2-year progression-free survival (PFS). RAZOR is a multi-institutional, randomized, non-inferior, phase III trial that will enrol at least 320 patients with T1–T4, N0–N1, M0 bladder cancer with ≈160 patients in both the RARC and ORC arms at 15 participating institutions. Data will be collected prospectively at each institution for cancer outcomes, complications of surgery and HRQL measures, and then submitted to trial data management services Cancer Research and Biostatistics (CRAB) for final analyses. To date, 306 patients have been randomized and accrual to the RAZOR trial is expected to conclude in 2014. In this study, we report the RAZOR trial experimental design, objectives, data safety, and monitoring, and accrual update. The RAZOR trial is a landmark study in urological oncology, randomizing T1–T4, N0–N1, M0 patients with bladder cancer to ORC vs RARC, PLND and urinary diversion. RAZOR is a multi-institutional, non-inferiority trial evaluating cancer outcomes, surgical complications and HRQL measures of ORC vs RARC with a primary endpoint of 2-year PFS. Full data from the RAZOR trial are not expected until 2016–2017. PMID:25626182

  1. Competing events and costs of clinical trials: Analysis of a randomized trial in prostate cancer

    International Nuclear Information System (INIS)

    Background: Clinical trial costs may be reduced by identifying enriched subpopulations of patients with favorable risk profiles for the events of interest. However, increased selectivity affects accrual rates, with uncertain impact on clinical trial cost. Methods: We conducted a secondary analysis of Southwest Oncology Group (SWOG) 8794 randomized trial of adjuvant radiotherapy for high-risk prostate cancer. The primary endpoint was metastasis-free survival (MFS), defined as time to metastasis or death from any cause (competing mortality). We used competing risks regression models to identify an enriched subgroup at high risk for metastasis and low risk for competing mortality. We applied a cost model to estimate the impact of enrichment on trial cost and duration. Results: The treatment effect on metastasis was similar in the enriched subgroup (HR, 0.42; 95% CI, 0.23–0.76) compared to the whole cohort (HR, 0.50; 95% CI, 0.30–0.81) while the effect on competing mortality was not significant in the subgroup or the whole cohort (HR 0.70; 95% CI 0.39–1.23, vs. HR 0.94; 95% CI, 0.68–1.31). Due to the higher incidence of metastasis relative to competing mortality in the enriched subgroup, the treatment effect on MFS was greater in the subgroup compared to the whole cohort (HR 0.55; 95% CI 0.36–0.82, vs. HR 0.77; 95% CI, 0.58–1.01). Trial cost was 75% less in the subgroup compared to the whole cohort ($1.7 million vs. $6.8 million), and the trial duration was 30% shorter (8.4 vs. 12.0 years). Conclusion: Competing event enrichment can reduce clinical trial cost and duration, without sacrificing generalizability

  2. 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.

  3. Antibiotic trials for coronary heart disease.

    Science.gov (United States)

    Anderson, Jeffrey L; Muhlestein, Joseph B

    2004-01-01

    The possibility has been raised in recent years that infection might contribute as an inflammatory stimulus to chronic "noninfectious" degenerative diseases. Within the past decade, serious attention has been given to the possibility of bacterial vectors as causal factors of atherosclerosis. To date, the greatest amount of information has related to the intracellular organism Chlamydia pneumoniae. This interest has been stimulated by the frequent finding of bacterial antigens and, occasionally, recoverable organisms, within human atherosclerotic plaque. Indirect evidence for and against the benefit of anti-Chlamydia antibiotic agents comes from epidemiologic studies. Given the potential for confounding in observational studies, prospective, randomized intervention trials are required. These antibiotic trials have generated enthusiastic expectations for proving (or disproving) the infectious-disease hypothesis of atherosclerosis and establishing new therapies. However, these expectations have been tempered by important limitations and uncertainties. Negative outcomes can be explained not only by an incorrect hypothesis but also by inadequate study size or design or by an ineffective antibiotic regimen. In contrast, if studies are positive, the hypothesis still is not entirely proved, because a nonspecific anti-inflammatory effect or an anti-infective action against other organisms might be operative. The clinical trial data to date have not provided adequate support for the clinical use of antibiotics in primary or secondary prevention of coronary heart disease. New and innovative experimental approaches, in addition to traditionally designed antibiotic trials, should be welcome in our attempts to gain adequate insight into the role of infection in atherosclerosis and its therapy. PMID:15061624

  4. Causal Mediation Analyses for Randomized Trials

    OpenAIRE

    Lynch, Kevin G.; Cary, Mark; Gallop, Robert; Ten Have, Thomas R.

    2008-01-01

    In the context of randomized intervention trials, we describe causal methods for analyzing how post-randomization factors constitute the process through which randomized baseline interventions act on outcomes. Traditionally, such mediation analyses have been undertaken with great caution, because they assume that the mediating factor is also randomly assigned to individuals in addition to the randomized baseline intervention (i.e., sequential ignorability). Because the mediating factors are t...

  5. Alternative methods to evaluate trial level surrogacy

    OpenAIRE

    CORTINAS ABRAHANTES, Jose; Shkedy, Ziv; Molenberghs, Geert

    2008-01-01

    Background The evaluation and validation of surrogate endpoints have been extensively studied in the last decade. Prentice [1] and Freedman, Graubard and Schatzkin [2] laid the foundations for the evaluation of surrogate endpoints in randomized clinical trials. Later, Buyse et al. [5] proposed a meta-analytic methodology, producing different methods for different settings, which was further studied by Alonso and Molenberghs [9], in their unifying approach based on information theory. Purpose ...

  6. 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.

  7. Friendship Dynamics Between Emotions and Trials

    OpenAIRE

    Paola Rebughini

    2011-01-01

    The aim of this article is to analyze friendship ties and the emotions connected to them in some particular phases of life: periods when subjects are faced with difficult challenges such as mourning, separation, job loss or illness. Under these circumstances, friendship ties and emotions take on exceptional intensity. To investigate this moments I will use the analytical concept of trial and I will outline its heuristic utility in the analysis of friendship ties. The article is based on a res...

  8. 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.

  9. Constructions of legitimacy: the Charles Taylor trial

    OpenAIRE

    Glasius, M.; Meijers, T.

    2012-01-01

    This article examines the discourses of the prosecution and the defence in the case of Charles Taylor before the Special Court for Sierra Leone. It contributes to current debates about the legitimacy and utility of international criminal justice, which have tended to neglect the examination of actual trials, and particularly the role of the defence. We draw on the legal doctrine of ‘expressivism’ to theorize the connection between normative legitimacy, actual support and the utility of intern...

  10. Clinical Trials and their Impact on Society

    OpenAIRE

    Olga Lidia Cuevas Pérez; Ana María Molina Gómez; Diana Rosa Fernández Ruiz

    2016-01-01

    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 evalu...

  11. Bacteriophage Therapy: Advances in Formulation Strategies and Human Clinical Trials.

    Science.gov (United States)

    Vandenheuvel, Dieter; Lavigne, Rob; Brüssow, Harald

    2015-11-01

    Recently, a number of phage therapy phase I and II safety trials have been concluded, showing no notable safety concerns associated with the use of phage. Though hurdles for efficient treatment remain, these trials hold promise for future phase III clinical trials. Interestingly, most phage formulations used in these clinical trials are straightforward phage suspensions, and not much research has focused on the processing of phage cocktails in specific pharmaceutical dosage forms. Additional research on formulation strategies and the stability of phage-based drugs will be of key importance, especially with phage therapy advancing toward phase III clinical trials. PMID:26958930

  12. Modernizing Eligibility Criteria for Molecularly Driven Trials.

    Science.gov (United States)

    Kim, Edward S; Bernstein, David; Hilsenbeck, Susan G; Chung, Christine H; Dicker, Adam P; Ersek, Jennifer L; Stein, Steven; Khuri, Fadlo R; Burgess, Earle; Hunt, Kelly; Ivy, Percy; Bruinooge, Suanna S; Meropol, Neal; Schilsky, Richard L

    2015-09-01

    As more clinical trials of molecularly targeted agents evolve, the number of eligibility criteria seems to be increasing. The importance and utility of eligibility criteria must be considered in the context of the fundamental goal of a clinical trial: to understand the risks and benefits of a treatment in the intended-use patient population. Although eligibility criteria are necessary to define the population under study and conduct trials safely, excessive requirements may severely restrict the population available for study, and often, this population is not reflective of the general population for which the drug would be prescribed. The American Society of Clinical Oncology Cancer Research Committee, which comprises academic faculty, industry representatives, and patient advocates, evaluated this issue. Evaluation results were mixed. Most physicians agreed that excessive eligibility criterias slow study enrollment rates and prolong the duration of enrollment; however, this hypothesis was difficult to validate with the data examined. We propose the organization of a public workshop, with input from regulatory bodies and key stakeholders, with the goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols, which may help guide future investigators and companies in streamlining eligibility criteria in the era of molecularly driven therapy. PMID:26195710

  13. Gateways to clinical trials. December 2008.

    Science.gov (United States)

    Tomillero, A; Moral, M A

    2008-12-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables 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: AAV1/SERCA2a; Abatacept, ABT-263, Adalimumab, Aflibercept, Afobazole, Aliskiren fumarate, Anakinra, Atazanavir/ritonavir, Aviscumine, Axitinib, Azacitidine; Bevacizumab, Biphasic insulin aspart, Bortezomib, Briobacept; Carmoterol hydrochloride, CCX-282, Ceftobiprole medocaril, Certolizumab pegol, Cetuximab; Darifenacin hydrobromide, Dasatinib, Denosumab, Doripenem, Duloxetine hydrochloride; E-7080, Epratuzumab, Erlotinib hydrochloride, Everolimus, Exenatide, Ezetimibe/simvastatin; Gefitinib, Golimumab; gamma-Hydroxybutyrate sodium; Imatinib mesylate, Insulin detemir, Insulin glulisine, IVX-0142; Laquinimod sodium, Linezolid, Lopinavir/ritonavir; Ocrelizumab, Omalizumab; Parecoxib sodium, Pemetrexed disodium, Pregabalin; Rosuvastatin calcium, Rotigotine; Sorafenib, Sugammadex sodium; Tapentadol hydrochloride, Tenofovir disoproxil fumarate/emtricitabine, Tocilizumab; Ularitide, Ustekinumab; Valsartan/amlodipine besylate, Varenicline tartrate, Vatalanib succinate, Vildagliptin, Vorinostat. PMID:19271026

  14. Clinical Trials and Treatment of ATL

    Directory of Open Access Journals (Sweden)

    Kunihiro Tsukasaki

    2012-01-01

    Full Text Available ATL is a distinct peripheral T-lymphocytic malignancy associated with human T-cell lymphotropic virus type I (HTLV-1. The diversity in clinical features and prognosis of patients with this disease has led to its subtype-classification into four categories, acute, lymphoma, chronic, and smoldering types, defined by organ involvement, and LDH and calcium values. In case of acute, lymphoma, or unfavorable chronic subtypes (aggressive ATL, intensive chemotherapy like the LSG15 regimen (VCAP-AMP-VECP is usually recommended if outside of clinical trials, based on the results of a phase 3 trial. In case of favorable chronic or smoldering ATL (indolent ATL, watchful waiting until disease progression has been recommended, although the long-term prognosis was inferior to those of, for instance, chronic lymphoid leukemia. Retrospective analysis suggested that the combination of interferon alpha and zidovudine was apparently promising for the treatment of ATL, especially for types with leukemic manifestation. Allogeneic hematopoietic stem cell transplantation (allo-HSCT is also promising for the treatment of aggressive ATL possibly reflecting graft versus ATL effect. Several new agent trials for ATL are ongoing and in preparation, including a defucosylated humanized anti-CC chemokine receptor 4 monoclonal antibody, IL2-fused with diphtheria toxin, histone deacetylase inhibitors, a purine nucleoside phosphorylase inhibitor, a proteasome inhibitor, and lenalidomide.

  15. 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. PMID:26374682

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

    Science.gov (United States)

    Ganju, Jitendra

    2016-01-01

    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. PMID:27439520

  17. 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.

  18. Methods for therapeutic trials in COPD: lessons from the TORCH trial

    DEFF Research Database (Denmark)

    Keene, O N; Vestbo, J; Anderson, J A;

    2009-01-01

    The TORCH (Towards a Revolution in COPD Health) trial has highlighted some important issues in the design and analysis of long term trials in chronic obstructive pulmonary disease. These include collection of off-treatment exacerbation data, analysis of exacerbation rates and the effect of...... inclusion of patients receiving inhaled corticosteroids (ICS) prior to randomisation. When effective medications are available to patients who withdraw, inclusion of off-treatment data can mask important treatment effects on exacerbation rates. Analysis of on-treatment data avoids this bias but it needs to...... be combined with careful analysis of withdrawal patterns across treatments. The negative binomial model is currently the best approach to statistical analysis of exacerbation rates, while analysis of time to exacerbation can supplement this approach. In the TORCH trial, exacerbation rates were higher...

  19. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.

    Science.gov (United States)

    Hernán, Miguel A; Robins, James M

    2016-04-15

    Ideally, questions about comparative effectiveness or safety would be answered using an appropriately designed and conducted randomized experiment. When we cannot conduct a randomized experiment, we analyze observational data. Causal inference from large observational databases (big data) can be viewed as an attempt to emulate a randomized experiment-the target experiment or target trial-that would answer the question of interest. When the goal is to guide decisions among several strategies, causal analyses of observational data need to be evaluated with respect to how well they emulate a particular target trial. We outline a framework for comparative effectiveness research using big data that makes the target trial explicit. This framework channels counterfactual theory for comparing the effects of sustained treatment strategies, organizes analytic approaches, provides a structured process for the criticism of observational studies, and helps avoid common methodologic pitfalls. PMID:26994063

  20. Homeopathic pathogenetic trial of Plumbum metallicum: the complete 2000 trial with a synthesis of the original 1828 trial

    OpenAIRE

    Christa Pichler; Andrea Maria Signorini

    2011-01-01

    Background: in a previous paper we reported the statistical analysis and other distribution data of a homeopathic pathogenetic trial (HPT) of Plumbum metallicum 30cH carried out by our group. However, at that time we did not report the resulting pure materia medica, i.e., the totality of symptoms elicited by the tested medicine on healthy volunteers. Aim: to communicate to the homeopathic community the full record of symptoms collected in our HPT of Plb. Methods: methods to collect and select...

  1. Key concepts of clinical trials: a narrative review.

    Science.gov (United States)

    Umscheid, Craig A; Margolis, David J; Grossman, Craig E

    2011-09-01

    The recent focus of federal funding on comparative effectiveness research underscores the importance of clinical trials in the practice of evidence-based medicine and health care reform. The impact of clinical trials not only extends to the individual patient by establishing a broader selection of effective therapies, but also to society as a whole by enhancing the value of health care provided. However, clinical trials also have the potential to pose unknown risks to their participants, and biased knowledge extracted from flawed clinical trials may lead to the inadvertent harm of patients. Although conducting a well-designed clinical trial may appear straightforward, it is founded on rigorous methodology and oversight governed by key ethical principles. In this review, we provide an overview of the ethical foundations of trial design, trial oversight, and the process of obtaining approval of a therapeutic, from its pre-clinical phase to post-marketing surveillance. This narrative review is based on a course in clinical trials developed by one of the authors (DJM), and is supplemented by a PubMed search predating January 2011 using the keywords "randomized controlled trial," "patient/clinical research," "ethics," "phase IV," "data and safety monitoring board," and "surrogate endpoint." With an understanding of the key principles in designing and implementing clinical trials, health care providers can partner with the pharmaceutical industry and regulatory bodies to effectively compare medical therapies and thereby meet one of the essential goals of health care reform. PMID:21904102

  2. A data grid for imaging-based clinical trials

    Science.gov (United States)

    Zhou, Zheng; Chao, Sander S.; Lee, Jasper; Liu, Brent; Documet, Jorge; Huang, H. K.

    2007-03-01

    Clinical trials play a crucial role in testing new drugs or devices in modern medicine. Medical imaging has also become an important tool in clinical trials because images provide a unique and fast diagnosis with visual observation and quantitative assessment. A typical imaging-based clinical trial consists of: 1) A well-defined rigorous clinical trial protocol, 2) a radiology core that has a quality control mechanism, a biostatistics component, and a server for storing and distributing data and analysis results; and 3) many field sites that generate and send image studies to the radiology core. As the number of clinical trials increases, it becomes a challenge for a radiology core servicing multiple trials to have a server robust enough to administrate and quickly distribute information to participating radiologists/clinicians worldwide. The Data Grid can satisfy the aforementioned requirements of imaging based clinical trials. In this paper, we present a Data Grid architecture for imaging-based clinical trials. A Data Grid prototype has been implemented in the Image Processing and Informatics (IPI) Laboratory at the University of Southern California to test and evaluate performance in storing trial images and analysis results for a clinical trial. The implementation methodology and evaluation protocol of the Data Grid are presented.

  3. Phase I trials involving radiation therapy, quantifying the risks

    International Nuclear Information System (INIS)

    Over one third of cancer patients receive radiation therapy (RT) at some point. Our purpose was to quantify the risks to patients associated with enrolment onto RT-based phase I trials. All phase I and phase I/II clinical trials involving RT published in English between 2001 and 2010 were identified via a PubMed search. For pragmatic reasons, we focused on trials from 2001, 2005 and 2009. For each trial we calculated a 'toxicity ratio' equal to the number of grade 3/4/5 toxic events divided by the number of patients in the trial. Linear regression was used to determine which variables were associated with higher toxicity ratios. There were a total of 33 treatment-related deaths, and 1812 acute grade 3/4 toxicities among the 2994 subjects in 98 trials. The median toxicity ratio over 98 trials was 0.46 (95% confidence interval (CI) 0.34 to 0.58). Multivariate regression analysis showed that toxicity ratios were significantly higher in trials with chemotherapy (P=0.002) and in trials for cancers of the head-and-neck (P<0.001). The median toxicity ratio in chemotherapy trials was 0.60 (95% CI: 0.48 to 0.72) compared with trials without chemotherapy 0.08 (95% CI: 0.03 to 0.13). Although the risk of grade 5 toxicity is low, the risk of major toxicity is significant in phase I RT trials. These values are comparable to published risk estimates for phase I non-RT trials.

  4. Stress Urinary Incontinence: Comparative Efficacy Trials.

    Science.gov (United States)

    Lavelle, Erin Seifert; Zyczynski, Halina M

    2016-03-01

    Women seeking relief from symptoms of stress urinary incontinence (SUI) may choose from a broad array of treatment options. Therapies range from lifestyle/behavioral modification to surgical interventions, and differ in terms of both effectiveness and risk. Individualized treatment plans can be developed to address a patient's expectations and goals for treatment, as well as her tolerance for potential adverse events. This article reviews the highest-quality clinical trials comparing contemporary treatment options for women with SUI. Clinicians and patients can use this compendium to inform their treatment selection. PMID:26880507

  5. 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...

  6. Statistical properties of randomization in clinical trials.

    Science.gov (United States)

    Lachin, J M

    1988-12-01

    This is the first of five articles on the properties of different randomization procedures used in clinical trials. This paper presents definitions and discussions of the statistical properties of randomization procedures as they relate to both the design of a clinical trial and the statistical analysis of trial results. The subsequent papers consider, respectively, the properties of simple (complete), permuted-block (i.e., blocked), and urn (adaptive biased-coin) randomization. The properties described herein are the probabilities of treatment imbalances and the potential effects on the power of statistical tests; the permutational basis for statistical tests; and the potential for experimental biases in the assessment of treatment effects due either to the predictability of the random allocations (selection bias) or the susceptibility of the randomization procedure to covariate imbalances (accidental bias). For most randomization procedures, the probabilities of overall treatment imbalances are readily computed, even when a stratified randomization is used. This is important because treatment imbalance may affect statistical power. It is shown, however, that treatment imbalance must be substantial before power is more than trivially affected. The differences between a population versus a permutation model as a basis for a statistical test are reviewed. It is argued that a population model can only be invoked in clinical trials as an untestable assumption, rather than being formally based on sampling at random from a population. On the other hand, a permutational analysis based on the randomization actually employed requires no assumptions regarding the origin of the samples of patients studied. The large sample permutational distribution of the family of linear rank tests is described as a basis for easily conducting a variety of permutation tests. Subgroup (stratified) analyses, analyses when some data are missing, and regression model analyses are also

  7. 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.

  8. Inactive trials of transport systems: phase II

    International Nuclear Information System (INIS)

    Progress made during 1984-85 is reviewed in four sections: the design and installation of a stainless steel working floor in the mock-up of a crate handling and size reduction facility; the detailed evaluation of a single air pad of the type used on commercial air-transporter; an experimental programme designed to examine the problems associated with the operation of a commercial air-transporter; the design, manufacture and commissioning trials of two powered conveyor units which when combined complete a remotely operated transfer system for transporting crated waste into and within the mock-up facility. (author)

  9. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  10. 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...... investigators agreed on the inclusion of trials and the outcome scale. For each trial, we calculated the difference in effect size (i.e., standardized mean difference between nonblinded and blinded assessments). A difference in effect size of less than 0 suggested that nonblinded assessors generated more...

  11. 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. PMID:26499195

  12. 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...... optimistic estimates of effect. We pooled the differences in effect size using inverse variance random-effects meta-analysis and used metaregression to identify potential reasons for variation. RESULTS: We included 24 trials in our review. The main meta-analysis included 16 trials (involving 2854 patients...

  13. 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...

  14. Randomised Controlled Trials in Education Research: A Case Study of an Individually Randomised Pragmatic Trial

    Science.gov (United States)

    Torgerson, Carole J.

    2009-01-01

    The randomised controlled trial (RCT) is an evaluative method used by social scientists in order to establish whether or not an intervention is effective. This contribution discusses the fundamental aspects of good RCT design. These are illustrated through the use of a recently completed RCT which evaluated an information and communication…

  15. 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

  16. 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.

  17. 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

  18. A Randomised Controlled Trial of complete denture impression materials

    OpenAIRE

    Hyde, T.P.; Craddock, H.L.; Gray, J C; Pavitt, S. H.; Hulme, C; Godfrey, M.; Fernandez, C; Navarro-Coy, N; Dillon, S.; Wright, J; S. Brown; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Denta...

  19. Trial Outcome and Associative Learning Signals in the Monkey Hippocampus

    OpenAIRE

    Wirth, Sylvia; Avsar, Emin; Chiu, Cindy C.; Sharma, Varun; Smith, Anne C.; Emery N Brown; Suzuki, Wendy A.

    2009-01-01

    In tasks of associative learning, animals establish new links between unrelated items by using information about trial outcome to strengthen correct/rewarded associations and modify incorrect/unrewarded ones. To study how hippocampal neurons convey information about reward and trial outcome during new associative learning, we recorded hippocampal neurons as monkeys learned novel object-place associations. A large population of hippocampal neurons (50%) signaled trial outcome by differentiatin...

  20. Implications of HIV PrEP Trials Results

    OpenAIRE

    Veronese, Fulvia; Anton, Peter; Fletcher, Courtney V.; DeGruttola, Victor; McGowan, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

    2011-01-01

    Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of H...

  1. Two-stage adaptive designs in early phase clinical trials

    OpenAIRE

    Xu, Jiajing; 徐佳静

    2013-01-01

    The primary goal of clinical trials is to collect enough scientific evidence for a new intervention. Despite the widespread use of equal randomization in clinical trials, response-adaptive randomization has attracted considerable interest in terms of ethical concerns. In this thesis, delayed response problems and innovative designs for cytostatic agents in oncology clinical trials are studied. There is typically a prerun of equal randomization before the implementation of response-adaptiv...

  2. Poor Reporting of Scientific Leadership Information in Clinical Trial Registers

    OpenAIRE

    Melanie Sekeres; Gold, Jennifer L.; An-Wen Chan; Joel Lexchin; David Moher; Van Laethem, Marleen L. P.; James Maskalyk; Lorraine Ferris; Nathan Taback; Rochon, Paula A

    2008-01-01

    BACKGROUND: In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. Th...

  3. Poor Reporting of Scientific Leadership Information in Clinical Trial Registers

    OpenAIRE

    Sekeres, Melanie; Jennifer L Gold; Chan, An-Wen; Lexchin, Joel; Moher, David; Van Laethem, Marleen L. P.; Maskalyk, James; Ferris, Lorraine; Taback, Nathan; Paula A Rochon

    2008-01-01

    Background In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The...

  4. 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.

  5. Controlled trial of azathioprine in chronic ulcerative colitis.

    OpenAIRE

    Kirk, A P; Lennard-Jones, J E

    1982-01-01

    A double-blind controlled trial of azathioprine in a dose of 2-2.5 mg/kg body weight over six months was conducted among 44 patients with active chronic ulcerative colitis. Three patients treated with placebo did not complete the trial because their disease became so severe that colectomy was performed. Among patients who completed the trial the mean dose of prednisolone necessary to control the disease decreased in those treated with azathioprine and those treated with placebo; the reduction...

  6. Current Status and Challenges of Cancer Clinical Trials in Korea

    OpenAIRE

    Shim, Byoung Yong; Park, Se Hoon; Lee, Soonil; Kim, Jin-Soo; Lee, Kyoung Eun; Kang, Yoon-Koo; Ahn, Myung-Ju

    2015-01-01

    Purpose Cancer clinical trials in Korea have rapidly progressed in terms of quantity and quality during the last decade. This study evaluates the current status of cancer clinical trials in Korea and their associated problems. Materials and Methods We analyzed the clinical trials approved by the Korea Food and Drug Administration (KFDA) between 2007 and 2013. A nationwide on-line survey containing 22 questions was also performed with several cooperative study groups and individual researchers...

  7. Figures in clinical trial reports: current practice & scope for improvement

    OpenAIRE

    Travison Thomas G; Pocock Stuart J; Wruck Lisa M

    2007-01-01

    Abstract Background Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. Purpose To evaluate the current use of figures in Trial reports, and to make constructive suggestions for future practice. Methods We surveyed all 77 reports of randomised controlled trials in five general medical journals during November 2006 to January 2007. The numbers and types of figures were determined, and then each Figure was assess...

  8. 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.

  9. Effectiveness of continuous glucose monitoring during diabetic pregnancy (GlucoMOMS trial; a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Voormolen Daphne N

    2012-12-01

    Full Text Available Abstract Background Hyperglycemia in pregnancy is associated with poor perinatal outcome. Even if pregnant women with diabetes are monitored according to current guidelines, they do much worse than their normoglycaemic counterparts, marked by increased risks of pre-eclampsia, macrosomia, and caesarean section amongst others. Continuous Glucose Monitoring (CGM is a new method providing detailed information on daily fluctuations, used to optimize glucose control. Whether this tool improves pregnancy outcome remains unclear. In the present protocol, we aim to assess the effect of CGM use in diabetic pregnancies on pregnancy outcome. Methods/design The GlucoMOMS trial is a multicenter open label randomized clinical trial with a decision and cost-effectiveness study alongside. Pregnant women aged 18 and over with either diabetes mellitus type 1 or 2 on insulin therapy or with gestational diabetes requiring insulin therapy before 30 weeks of gestation will be asked to participate. Consenting women will be randomly allocated to either usual care or complementary CGM. All women will determine their glycaemic control by self-monitoring of blood glucose levels and HbA1c. In addition, women allocated to CGM will use it for 5–7 days every six weeks. Based on their CGM profiles they receive dietary advice and insulin therapy adjustments if necessary. The primary outcome measure is rate of macrosomia, defined as a birth weight above the 90th centile. Secondary outcome measures will be birth weight, composite neonatal morbidity, maternal outcome and costs. The analyses will be according to the intention to treat principle. Discussion With this trial we aim at clarifying whether the CGM improves pregnancy outcome when used during diabetic pregnancies. Trial registration Nederlands Trial Register: NTR2996

  10. 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

  11. Comparison of published orthopaedic trauma trials following registration in Clinicaltrials.gov

    OpenAIRE

    Gandhi Rajiv; Jan Meryam; Smith Holly N; Mahomed Nizar N; Bhandari Mohit

    2011-01-01

    Abstract Background After the Food and Drug Administration Modernization Act of 1997, the registration of all clinical trials became mandatory prior to publication. Our primary objective was to determine publication rates for orthopaedic trauma trials registered with ClinicalTrials.gov. We further evaluated methodological consistency between registration and publication. Methods We searched Clinical Trials.gov for all trials related to orthopaedic trauma. We excluded active trials and trials ...

  12. End points in dermatologic clinical trials: A review for clinicians.

    Science.gov (United States)

    Wei, Erin X; Kirsner, Robert S; Eaglstein, William H

    2016-07-01

    Clinical trials are critical for the development of new therapies in dermatology, and their results help determine US Food and Drug Administration (FDA) approval and guide care. Of special relevance is the clinical trial efficacy end point, the metric from which statistically significant outcome is derived. Clinicians' understanding of a clinical trial's end point is necessary for critical analysis of the trial results and for applying those results to daily practice. This review provides practical knowledge and critical evaluation of end points used in treatment approvals by the FDA. The end points for actinic keratosis, acne vulgaris, atopic dermatitis, onychomycosis, and cutaneous ulcer serve as examples. PMID:26936300

  13. 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

  14. Citation bias of hepato-biliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Gluud, Christian

    2002-01-01

    The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985......-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index...

  15. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G;

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial...

  16. Statistical considerations for a trial of Ebola virus disease therapeutics.

    Science.gov (United States)

    Proschan, Michael A; Dodd, Lori E; Price, Dionne

    2016-02-01

    The 2014 West African outbreak of Ebola virus ravaged Liberia, Sierra Leone, and Guinea, causing hemorrhagic fever and death. The need to identify effective therapeutics was acute. The usual drug development paradigm of phase I, followed by phase II, and then phase III trials would take too long. These and other factors led to the design of a clinical trial of Ebola virus disease therapeutics that differs from more conventional clinical trial designs. This article describes the Ebola virus disease medical countermeasures trial design and the thinking behind it. PMID:26768567

  17. 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.

  18. 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...

  19. Reduced Muscle Pain Intensity Rating During Repeated Cycling Trials

    OpenAIRE

    Marino, Frank E.; Derek Kay; Micalos, Peter S.

    2004-01-01

    The purpose of this study was to investigate muscle pain intensity rating using a 10-point category-ratio pain intensity scale during self-paced cycling exercise within three trials. Eleven subjects (age 21.4 ± 2.6 years; VO2 peak 3.3 ± 0.9 L·min-1) performed a 60-min cycling trial on three occasions. During each trial subjects cycled at the utmost work intensity for 60-min. To simulate competitive training, 1-min maximal effort sprints were performed every 10-mins into the trial. Ambient tem...

  20. 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.

  1. Homeopathic pathogenetic trial of Plumbum metallicum: the complete 2000 trial with a synthesis of the original 1828 trial

    Directory of Open Access Journals (Sweden)

    Christa Pichler

    2011-03-01

    Full Text Available Background: in a previous paper we reported the statistical analysis and other distribution data of a homeopathic pathogenetic trial (HPT of Plumbum metallicum 30cH carried out by our group. However, at that time we did not report the resulting pure materia medica, i.e., the totality of symptoms elicited by the tested medicine on healthy volunteers. Aim: to communicate to the homeopathic community the full record of symptoms collected in our HPT of Plb. Methods: methods to collect and select symptoms have been reported in the previous paper. In synthesis were excluded all previous common symptoms of volunteers, even with slight differences, and selected only those that were really unknown, never seen, unusual or very strange for the prover. In this paper special emphasis was given to new symptoms as well as unusual or repeated dreams, while in the previous paper special emphasis was given to repeated and crossed symptoms. Results: symptoms are reported in their chronological order of appearance in each volunteer. 37 new symptoms were found, useful to update Homeopathic Repertories. It is also included a synthesis of the original HPT of Plb carried out in 1828 in order to make available the full experimental materia medica currently existing. Conclusions: the new HPT, besides widening the pathogenetic picture of Plb (skin and mucosae symptoms, also allowed us to give new and deeper meanings to some of the symptoms reported in the original trial, such as Anxiety, Activity, Depression, Slowness, Gastro-oesophageal problems, Colitis. The dreams complete the remedy image, mainly in work, religion and sexual themes. Up to the present time there is no peer-reviewed publication devoted to HPTs. For this reason, researchers are compelled to publish HPTs as private editions. This results in poor control of the quality of publications and a lack of standards on how to present the results of HPTs.

  2. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

    OpenAIRE

    Mullan Rebecca J; Bankhead Clare R; Kaur Jagdeep; Sood Amit; Raatz Heike; Mulla Sohail M; Burns Karen EA; Nordmann Alain J; Lampropulos Julianna F; Bucher Heiner C; Karanicolas Paul J; You John J; Elnour Nisrin; Soares Heloisa P; Kirpalani Haresh

    2009-01-01

    Abstract Background Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiol...

  3. Inferring trial-to-trial excitatory and inhibitory synaptic inputs from membrane potential using Gaussian mixture Kalman filtering

    OpenAIRE

    Milad Lankarany

    2013-01-01

    Time-varying excitatory and inhibitory synaptic inputs govern activity of neurons and process information in the brain. The importance of trial-to-trial fluctuations of synaptic inputs has recently been investigated in neuroscience. Such fluctuations are ignored in the most conventional techniques because they are removed when trials are averaged during linear regression techniques. Here, we propose a novel recursive algorithm based on Gaussian mixture Kalman filtering (GMKF) for estimating t...

  4. 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...

  5. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    OpenAIRE

    Keeling Sally; Peri Kathy; Hatcher Simon; Elley C Raina; Dowell Tony; Kolt Gregory S; Hayman Karen J; Moyes Simon A; Falloon Karen; Kerse Ngaire; Robinson Elizabeth; Parsons John; Wiles Janine; Arroll Bruce

    2008-01-01

    Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE) is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years a...

  6. [Difficulties with conducting clinical trials in France].

    Science.gov (United States)

    Zannad, F; Plétan, Y

    2001-01-01

    France ranks third among European countries as regards the level of investment in clinical R&D and, overall, accounts for a contributive effort proportional to the size of its population and pharmaceutical market respectively. However, there is a trend for phase II and III studies to become proportionally fewer than in the past, while the number of phase IV studies is increasing. In a growing proportion of the mega-trials, which are instrumental for establishing evidence-based practice, French experts, investigators and, even more seriously, French patients, are insufficiently represented. Though studies in France are initiated relatively fast due to a clear regulatory framework and perform equally well as far as quantitative and qualitative factors are concerned, compared with most European countries involved in clinical research the costs incurred per completed patient are higher than those recorded in the other countries. Academic research shares most of these constraints and suffers from a lack of financial and human resources, while it faces additional delays in implementing studies because of longer administrative processes. Given the stakes in play, specific solutions should be implemented to maintain and further develop French competitiveness in clinical R&D. At the patient level, positive perception and awareness of the usefulness and safety of participating in clinical trials need to be emphasized. Education at the school level and using the lay media should be developed. Intervention of institutional and government officials is much needed. Direct patient recruitment should be developed through advertisement and the Internet, as well as within doctors' offices and through collaboration with patients' organizations. Patient information and consent forms should be made much simpler than those imposed within the framework of global studies because of FDA requirements. The French health system discourages the recruitment of patients by investigators who are

  7. Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial

    Directory of Open Access Journals (Sweden)

    Guallar Eliseo

    2010-12-01

    Full Text Available Abstract Background Overweight and obesity are highly prevalent among persons with serious mental illness. These conditions likely contribute to premature cardiovascular disease and a 20 to 30 percent shortened life expectancy in this vulnerable population. Persons with serious mental illness need effective, appropriately tailored behavioral interventions to achieve and maintain weight loss. Psychiatric rehabilitation day programs provide logical intervention settings because mental health consumers often attend regularly and exercise can take place on-site. This paper describes the Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE. The goal of the study is to determine the effectiveness of a behavioral weight loss intervention among persons with serious mental illness that attend psychiatric rehabilitation programs. Participants randomized to the intervention arm of the study are hypothesized to have greater weight loss than the control group. Methods/Design A targeted 320 men and women with serious mental illness and overweight or obesity (body mass index ≥ 25.0 kg/m2 will be recruited from 10 psychiatric rehabilitation programs across Maryland. The core design is a randomized, two-arm, parallel, multi-site clinical trial to compare the effectiveness of an 18-month behavioral weight loss intervention to usual care. Active intervention participants receive weight management sessions and physical activity classes on-site led by study interventionists. The intervention incorporates cognitive adaptations for persons with serious mental illness attending psychiatric rehabilitation programs. The initial intensive intervention period is six months, followed by a twelve-month maintenance period in which trained rehabilitation program staff assume responsibility for delivering parts of the intervention. Primary outcomes are weight loss at six and 18 months. Discussion Evidence-based approaches to the high burden

  8. 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

  9. 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

  10. 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

  11. The Danish Cardiovascular Screening Trial (DANCAVAS)

    DEFF Research Database (Denmark)

    Diederichsen, Axel Cosmus Pyndt; Rasmussen, Lars Melholt; Søgaard, Rikke;

    2015-01-01

    to be 70 %. DISCUSSION: The primary aim of this so far stand-alone population-based, randomized trial will be to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic...... cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a...... events, and whether the possible health benefits are cost effective. OUTCOME: Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome). RANDOMIZATION: Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those...

  12. Trial by Jury in Russian Military Courts

    Directory of Open Access Journals (Sweden)

    Nikolai P. Kovalev

    2008-07-01

    Full Text Available One of peculiar features of the military criminal justice system in Russia is that in some cases military defendants may apply for trial by jury. Unlike the existing U.S. court-martial jury and the Russian military jury of the early 1900s (World War I period which were comprised of the members of the armed forces, in modern Russia jurors trying military defendants are civilians. This article aims to provide a brief history of military jury in Russia and identify issues of independence and impartiality in Russian military courts with participation of lay decision-makers. In particular, the article will analyze two high-profile cases which resulted in acquittals of Russian officers accused of killing several Chechen civilians during counter-terrorist operations in Chechnya.

  13. Causal Mediation Analyses for Randomized Trials.

    Science.gov (United States)

    Lynch, Kevin G; Cary, Mark; Gallop, Robert; Ten Have, Thomas R

    2008-01-01

    In the context of randomized intervention trials, we describe causal methods for analyzing how post-randomization factors constitute the process through which randomized baseline interventions act on outcomes. Traditionally, such mediation analyses have been undertaken with great caution, because they assume that the mediating factor is also randomly assigned to individuals in addition to the randomized baseline intervention (i.e., sequential ignorability). Because the mediating factors are typically not randomized, such analyses are unprotected from unmeasured confounders that may lead to biased inference. We review several causal approaches that attempt to reduce such bias without assuming that the mediating factor is randomized. However, these causal approaches require certain interaction assumptions that may be assessed if there is enough treatment heterogeneity with respect to the mediator. We describe available estimation procedures in the context of several examples from the literature and provide resources for software code. PMID:19484136

  14. Diagnostic trials using CT scanning in urology

    Energy Technology Data Exchange (ETDEWEB)

    Fujita, T. (Fujita Gakuen Univ., Toyoake, Aichi (Japan). School of Medicine)

    1981-07-01

    We attempted various new diagnostic trials using CT scanning. The results obtained were: 1) Twelve transplanted kidneys were scanned after bolus contrast administration. Enhancing indices (EI) calculated from the formula: EI = (CT numbers 10 minutes after injection) / (CT numbers before injection) were inversely proportional to serum creatinine. 2) CT guided puncture was successful in percutaneous nephrostomy in 3 of 5 cases of obstructive uropathy and in 5 cases of renal cystic disease. 3) Emergent CT scans were diagnostically useful in 9 cases of urinary tract injury to indicate surgery. 4) CT scans after perivesical pneumography in 5 cases of vesical tumor diclosed perivesical invasion. 5) Cervical CT scans were performed as a localization study of parathyroid gland in 3 cases of secondary hyperparathyroidism in chronic renal insufficiency. More than 1400 mg of parathyroid gland in the neck was clearly visualized on cervical CT scans.

  15. European Nicotinamide Diabetes Intervention Trial (ENDIT)

    DEFF Research Database (Denmark)

    Gale, E A M; Bingley, P J; Emmett, C L;

    2004-01-01

    assess whether high dose nicotinamide prevents or delays clinical onset of diabetes in people with a first-degree family history of type 1 diabetes. METHOD: We did a randomised double-blind placebo-controlled trial of nicotinamide in 552 relatives with confirmed islet cell antibody (ICA) levels of 20...... Juvenile Diabetes Federation (JDF) units or more, and a non-diabetic oral glucose tolerance test. Participants were recruited from 18 European countries, Canada, and the USA, and were randomly allocated oral modified release nicotinamide (1.2 g/m2) or placebo for 5 years. Random allocation was done with a...... pseudorandom number generator and we used size balanced blocks of four and stratified by age and national group. Primary outcome was development of diabetes, as defined by WHO criteria. Analysis was done on an intention-to-treat basis. FINDINGS: There was no difference in the development of diabetes between...

  16. EURADOS trial performance test for photon dosimetry

    International Nuclear Information System (INIS)

    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 312 single results, 26 fell outside the limits of the trumpet curve and 32 were outside the range 1/1.5. Most outliers resulted from high energy R-F irradiations without electronic equilibrium. These fields are not routinely encountered by many of the participating dosimetry services. If the results for this field are excluded, most participating services satisfied the evaluation criteria. (author)

  17. 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...

  18. HIV-1 Eradication: Early Trials (and Tribulations).

    Science.gov (United States)

    Spivak, Adam M; Planelles, Vicente

    2016-01-01

    Antiretroviral therapy (ART) has rendered HIV-1 infection a manageable illness for those with access to treatment. However, ART does not lead to viral eradication owing to the persistence of replication-competent, unexpressed proviruses in long-lived cellular reservoirs. The potential for long-term drug toxicities and the lack of access to ART for most people living with HIV-1 infection have fueled scientific interest in understanding the nature of this latent reservoir. Exploration of HIV-1 persistence at the cellular and molecular level in resting memory CD4(+) T cells, the predominant viral reservoir in patients on ART, has uncovered potential strategies to reverse latency. We review recent advances in pharmacologically based 'shock and kill' HIV-1 eradication strategies, including comparative analysis of early clinical trials. PMID:26691297

  19. Commentary: Pursuing justice in death penalty trials.

    Science.gov (United States)

    Watson, Clarence; Eth, Spencer; Leong, Gregory B

    2012-01-01

    The capital trial, by its nature, is fraught with emotionally disturbing elements that jurors must face when deciding the ultimate fate of a guilty defendant. A confluence of mitigating and aggravating factors influences a capital jury's decision to impose a sentence of death. The presence or absence of defendant remorse in these cases may make all the difference in whether a capital defendant's life is spared. This commentary examines the onerous emotional toll encountered by capital jurors in light of the findings of Corwin and colleagues regarding defendant remorse and juror's need for affect. The commentary also presents practical and ethics-related considerations that should be kept in mind when reflecting on their study. PMID:22396341

  20. The Svalbard shoreline oilspill field trials

    International Nuclear Information System (INIS)

    The 1997 Svalbard shoreline oil spill field experiment was conducted to quantify the effectiveness of different in situ shoreline treatment options that are commonly used to accelerate natural oil removal processes on mixed coarse sediment beaches. Three experimental sites were chosen near the mining town of Sveagruva on Spitsbergen, the largest island in Svalbard, Norway. 5,500 litres of an intermediate fuel oil, was applied directly to a 3 m wide area of the upper intertidal zone sediment surface in a controlled and uniform manner. Full scale treatments began one week after oiling to allow for wave and tidal washing and stabilization of the oiled zone. Five treatment options were used: (1) sediment relocation, (2) tilling (or aeration); (3) bioremediation, (4) tilling combined with bioremediation, and (5) natural recovery. The sediment was treated in the same way as in an actual response operation. The trials were successful from both an operational and experimental point of view. 14 refs., 2 tabs., 9 figs

  1. Tyranny of the randomised clinical trial.

    Science.gov (United States)

    Rosenbek, John C

    2016-06-01

    Researchers and clinicians often disagree about what it means to provide the best possible care. This paper's purpose is to propose ways of resolving the disagreements. The first is to have both groups re-examine the three equal components of evidence-based practice, a re-examination that begins with rejection of the randomised clinical trial's tyranny. The second is for researchers to design rehabilitation research based on a biopsychosocial rather than a biomedical model. The third is for both groups to redefine translational research so that it means both translation from the laboratory to the clinic and from the clinic to the laboratory. The fourth is to advocate for a science of dissemination that is as robust as rehabilitation's present science of discovery. Most examples are drawn from the literature on acquired neurologic speech and language disorders. PMID:27124262

  2. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make a qual...

  3. Perceptions of Reimbursement for Clinical Trial Participation

    Science.gov (United States)

    Breitkopf, Carmen Radecki; Loza, Melissa; Vincent, Kathleen; Moench, Thomas; Stanberry, Lawrence R.; Rosenthal, Susan L.

    2012-01-01

    A greater understanding of participant views regarding reimbursement will help investigators plan studies that have better potential for reaching target enrollment, maximize efficient recruitment, maintain scientific integrity, and enhance retention over time. As part of a clinical trial in the area of sexual health, healthy women’s perceptions of reimbursement for research participation were investigated. Semi-structured, audio-recorded, qualitative interviews were conducted immediately upon women’s completion of the clinical trial to enable a participant-driven understanding of perceptions about monetary reimbursement. Audio-recordings were transcribed and analyzed using framework analysis. Women (N = 30) had a mean age of 29.5 ± 5.7 years (range 22–45 years). Sixty-three percent of participants (n = 19) were non-Hispanic (white n = 13, black n = 4, and Asian n = 2), while the remaining were Hispanic (n = 11). Seventy-three percent (n = 22) reported previous participation in research. In general, women viewed reimbursement as a benefit to research participation, the amount of which should reflect time, the inconvenience to the research subject, and the potential for unknown risks in the short- and long-term. They believed reimbursement should take into account the degree of risk of the study, with investigations of experimental products offering greater reimbursement. Women believed that monetary reimbursement is unlikely to coerce an individual to volunteer for a study involving procedures or requirements that they found unacceptable. The results of this study can be used to provide guidance to those planning and evaluating reimbursement for research participation. PMID:21931235

  4. Rationale for the tinnitus retraining therapy trial

    Directory of Open Access Journals (Sweden)

    Craig Formby

    2013-01-01

    Full Text Available The Tinnitus Retraining Therapy Trial (TRTT is a National Institutes of Health-sponsored, multi-centered, placebo-controlled, randomized trial evaluating the efficacy of tinnitus retraining therapy (TRT and its component parts, directive counseling and sound therapy, as treatments for subjective debilitating tinnitus in the military. The TRTT will enroll 228 individuals at an allocation ratio of 1:1:1 to: (1 directive counseling and sound therapy using conventional sound generators; (2 directive counseling and placebo sound generators; or (3 standard of care as administered in the military. Study centers include a Study Chair′s Office, a Data Coordinating Center, and six Military Clinical Centers with treatment and data collection standardized across all clinics. The primary outcome is change in Tinnitus Questionnaire (TQ score assessed longitudinally at 3, 6, 12, and 18-month follow-up visits. Secondary outcomes include: Change in TQ sub-scales, Tinnitus Handicap Inventory, Tinnitus Functional Index, and TRT interview visual analog scale; audiometric and psychoacoustic measures; and change in quality of life. The TRTT will evaluate TRT efficacy by comparing TRT (directive counseling and conventional sound generators with standard of care; directive counseling by comparing directive counseling plus placebo sound generators versus standard of care; and sound therapy by comparing conventional versus placebo sound generators. We hypothesize that full TRT will be more efficacious than standard of care, directive counseling and placebo sound generators more efficacious than standard of care, and conventional more efficacious than placebo sound generators in habituating the tinnitus awareness, annoyance, and impact on the study participant′s life.

  5. Gateways to Clinical Trials. June 2002.

    Science.gov (United States)

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

    2002-06-01

    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 Studies 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: Abacavir sulfate, abarelix, abciximab, alicaforsen sodium, almotriptan, alteplase, amlodipine, amoxicillin trihydrate, amprenavir, argatroban monohydrate, aspirin, atorvastatin calcium, azathioprine; Baclofen, benidipine hydrochloride, benserazide, BMS-214662, bosentan, botulinum toxin type B; Candesartan cilexetil, carbamazepine, carbidopa, carboplatin, ceftriaxone sodium, celecoxib, cetirizine hydrochloride, clarithromycin, clavulanate potassium, clopidogrel hydrogensulfate, clozapine, CPI-1189, cyclophosphamide, cytarabine; Darbepoetin alfa, denileukin diftitox, dexamethasone, dipyridamole, droperidol, DW-166HC; Ebastine, efalizumab, efavirenz, eletriptan, enalapril maleate, enfuvirtide, enoxaparin sodium, enrasentan, entacapone, epoetin, eprosartan mesilate, etanercept, etoricoxib; Fenofibratefexofenadine hydrochloride, filgrastim, fludarabine phosphate, fluoxetine hydrochloride fluvoxamine maleate, frovatriptan, furosemide; Gabapentin, galantamine hydrobromide, gatifloxacin, gefitinib, ghrelin (human), glatiramer acetate; Haloperidol; Ibuprofen, ibuprofen, guaiacol ester, idarubicin hydrochloride, imipramine hydrochloride, imiquimod, interferon beta, interferon beta-1a, interferon beta-1b, interferon omega, irbesartan, itraconazole; Ketorolac, ketorolac tromethamine; Lamifiban, lamotrigine, lanoteplase, lansoprazole, leflunomide, leuprorelin acetate, levetiracetam, levocetirizine, levodopa, lisinopril, loratadine; Manidipine, methylprednisolone, metronidazole, mirtazapine, mizolastine, modafinil, morphine sulfate; Naproxen sodium, naratriptan hydrochloride, nifedipine, NSC-683864; Ofloxacin, olanzapine

  6. Student Participation in Rover Field Trials

    Science.gov (United States)

    Bowman, C. D.; Arvidson, R. E.; Nelson, S. V.; Sherman, D. M.; Squyres, S. W.

    2001-12-01

    The LAPIS program was developed in 1999 as part of the Athena Science Payload education and public outreach, funded by the JPL Mars Program Office. For the past three years, the Athena Science Team has been preparing for 2003 Mars Exploration Rover Mission operations using the JPL prototype Field Integrated Design and Operations (FIDO) rover in extended rover field trials. Students and teachers participating in LAPIS work with them each year to develop a complementary mission plan and implement an actual portion of the annual tests using FIDO and its instruments. LAPIS is designed to mirror an end-to-end mission: Small, geographically distributed groups of students form an integrated mission team, working together with Athena Science Team members and FIDO engineers to plan, implement, and archive a two-day test mission, controlling FIDO remotely over the Internet using the Web Interface for Telescience (WITS) and communicating with each other by email, the web, and teleconferences. The overarching goal of LAPIS is to get students excited about science and related fields. The program provides students with the opportunity to apply knowledge learned in school, such as geometry and geology, to a "real world" situation and to explore careers in science and engineering through continuous one-on-one interactions with teachers, Athena Science Team mentors, and FIDO engineers. A secondary goal is to help students develop improved communication skills and appreciation of teamwork, enhanced problem-solving skills, and increased self-confidence. The LAPIS program will provide a model for outreach associated with future FIDO field trials and the 2003 Mars mission operations. The base of participation will be broadened beyond the original four sites by taking advantage of the wide geographic distribution of Athena team member locations. This will provide greater numbers of students with the opportunity to actively engage in rover testing and to explore the possibilities of

  7. Contemporary issues in clinical trials for medulloblastoma

    International Nuclear Information System (INIS)

    Medulloblastoma is the seminal pediatric brain tumor providing opportunities for clinical investigation to define improved treatment strategies for both disease control and ultimate functional integrity. Recent studies addressing neuraxis radiation dose provide a 'standard' for conventional therapy while establishing 5-year disease control rates for 'favorable' or 'low risk' presentations approximating 60% following surgery and irradiation. A highly visible recent report of combined post-operative irradiation and chemotherapy incorporating a platinum- and alkylator-based regimen indicates 5-year disease control approaching 90% in localized medulloblastoma. Despite unfavorable outcome with reduced-dose neuraxis irradiation in earlier trials, further data from recent studies suggest the addition of post-operative chemotherapy to similarly reduced-dose neuraxis irradiation (23.4 Gy) in 'favorable' presentations may result in progression-free survival rates at least equivalent to those achieved with full-dose neuraxis irradiation (36 Gy) absent chemotherapy. The panel will (1) provide updated information regarding the major clinical trials that form the basis for current and planned protocols and (2) debate the therapeutic modifications appropriate for contemporary clinical investigations. Critical in planning future studies in the analysis of risk factors that may identify 'favorable' patients versus 'high risk' patients. Risk-related studies appropriately address maintaining or improving current disease control rates in the context of diminishing late treatment sequelae for 'favorable' presentations. For those identified as 'high risk' (e.g., patients with disease beyond the primary site), studies are in development that increase the intensity of chemotherapy and explore modifications of radiation delivery. Study designs that permit assessment of innovations in surgical, radiotherapeutic, and chemotherapeutic approaches will be presented and debated by the panelists

  8. Impact of aprotinin and renal function on mortality: a retrospective single center analysis

    Directory of Open Access Journals (Sweden)

    Von Visger Jon

    2011-08-01

    Full Text Available Abstract Background An estimated up to 7% of high-risk cardiac surgery patients return to the operating room for bleeding. Aprotinin was used extensively as an antifibrinolytic agent in cardiac surgery patients for over 15 years and it showed efficacy in reducing bleeding. Aprotinin was removed from the market by the U.S. Food and Drug Administration after a large prospective, randomized clinical trial documented an increased mortality risk associated with the drug. Further debate arose when a meta-analysis of 211 randomized controlled trials showed no risk of renal failure or death associated with aprotinin. However, only patients with normal kidney function have been studied. Methods In this study, we look at a single center clinical trial using patients with varying degrees of baseline kidney function to answer the question: Does aprotinin increase odds of death given varying levels of preoperative kidney dysfunction? Results Based on our model, aprotinin use was associated with a 3.8-fold increase in odds of death one year later compared to no aprotinin use with p-value = 0.0018, regardless of level of preoperative kidney dysfunction after adjusting for other perioperative variables. Conclusions Lessons learned from our experience using aprotinin in the perioperative setting as an antifibrinolytic during open cardiac surgery should guide us in testing future antifibrinolytic drugs for not only efficacy of preventing bleeding, but for overall safety to the whole organism using long-term clinical outcome studies, including those with varying degree of baseline kidney function.

  9. Application of remote sensing to agricultural field trials.

    NARCIS (Netherlands)

    Clevers, J.G.P.W.

    1986-01-01

    Remote sensing techniques enable quantitative information about a field trial to be obtained instantaneously and non-destructively. The aim of this study was to identify a method that can reduce inaccuracies in field trial analysis, and to identify how remote sensing can support and/or replace conve

  10. An irrational trial equation method and its applications

    Indian Academy of Sciences (India)

    Xing-Hua Du

    2010-09-01

    An irrational trial equation method was proposed to solve nonlinear differential equations. By this method, a number of exact travelling wave solutions to the Burgers–KdV equation and the dissipative double sine-Gordon equation were obtained. A more general irrational trial equation method was discussed, and many exact solutions to the Fujimoto–Watanabe equation were given.

  11. 20 CFR 220.170 - The trial work period.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false The trial work period. 220.170 Section 220.170 Employees' Benefits RAILROAD RETIREMENT BOARD REGULATIONS UNDER THE RAILROAD RETIREMENT ACT DETERMINING DISABILITY Trial Work Period and Reentitlement Period for Annuitants Disabled for Any...

  12. 28 CFR 52.02 - Criminal proceedings: Pretrial, trial.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Criminal proceedings: Pretrial, trial. 52.... MAGISTRATE JUDGES § 52.02 Criminal proceedings: Pretrial, trial. (a) A judge of the district court, without the parties' consent, may designate a magistrate judge to hear and determine criminal pretrial...

  13. Training Residential Staff to Conduct Trial-Based Functional Analyses

    Science.gov (United States)

    Lambert, Joseph M.; Bloom, Sarah E.; Kunnavatana, S. Shanun; Collins, Shawnee D.; Clay, Casey J.

    2013-01-01

    We taught 6 supervisors of a residential service provider for adults with developmental disabilities to train 9 house managers to conduct trial-based functional analyses. Effects of the training were evaluated with a nonconcurrent multiple baseline. Results suggest that house managers can be trained to conduct trial-based functional analyses with…

  14. Reforms speed initiation of NCI-sponsored clinical trials

    Science.gov (United States)

    The process of opening a cancer clinical trial for patient accrual often takes years, and research has shown that trials which are slow to register patients often fail to finish. Following a thorough review, NCI’s Operational Efficiency Working Group prod

  15. Review on clinical trials of targeted treatments in malignant mesothelioma

    DEFF Research Database (Denmark)

    Jakobsen, Jan Nyrop; Sørensen, Jens Benn

    2011-01-01

    Malignant mesothelioma (MM) is an aggressive tumor of the serosal surfaces with a poor prognosis. Advances in the understanding of tumor biology have led to the development of several targeted treatments, which have been evaluated in clinical trials. This article is a comprehensive review of all...... clinical trials evaluating the effect of targeted treatments in MM....

  16. 20 CFR 404.1592 - The trial work period.

    Science.gov (United States)

    2010-04-01

    ....1592 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY... of disability benefit under title II of the Social Security Act (i.e., child's benefits based on... the trial work period in determining whether your disability ended at any time after the trial...

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

    DEFF Research Database (Denmark)

    Dellson, Pia; Nilbert, Mef; Carlsson, Christina

    2016-01-01

    future simplified and more attractive informed consent forms. CONCLUSIONS: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language......, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials....

  18. Cluster randomised trials in the medical literature: two bibliometric surveys

    Directory of Open Access Journals (Sweden)

    Bland J Martin

    2004-08-01

    Full Text Available Abstract Background Several reviews of published cluster randomised trials have reported that about half did not take clustering into account in the analysis, which was thus incorrect and potentially misleading. In this paper I ask whether cluster randomised trials are increasing in both number and quality of reporting. Methods Computer search for papers on cluster randomised trials since 1980, hand search of trial reports published in selected volumes of the British Medical Journal over 20 years. Results There has been a large increase in the numbers of methodological papers and of trial reports using the term 'cluster random' in recent years, with about equal numbers of each type of paper. The British Medical Journal contained more such reports than any other journal. In this journal there was a corresponding increase over time in the number of trials where subjects were randomised in clusters. In 2003 all reports showed awareness of the need to allow for clustering in the analysis. In 1993 and before clustering was ignored in most such trials. Conclusion Cluster trials are becoming more frequent and reporting is of higher quality. Perhaps statistician pressure works.

  19. Perspectives on randomized clinical trials : the case for albuminuria

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo Jan

    2008-01-01

    Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious random

  20. The Danish randomized lung cancer CT screening trial

    DEFF Research Database (Denmark)

    Pedersen, Jesper H; Ashraf, Haseem; Dirksen, Asger;

    2009-01-01

    INTRODUCTION: Lung cancer screening with low dose computed tomography (CT) has not yet been evaluated in randomized clinical trials, although several are underway. METHODS: In The Danish Lung Cancer Screening Trial, 4104 smokers and previous smokers from 2004 to 2006 were randomized to either...

  1. Randomized clinical trial of total vs. subtotal hysterectomy

    DEFF Research Database (Denmark)

    Gimbel, Helga; Zobbe, Vibeke; Ottesen, Bent S;

    2002-01-01

    To ensure the internal validity of a trial it is recommended to undertake a validation study of the method measuring the outcome.......To ensure the internal validity of a trial it is recommended to undertake a validation study of the method measuring the outcome....

  2. Use of 'sham' radiotherapy in randomized clinical trials

    International Nuclear Information System (INIS)

    The objective of this systematic review was to identify quality trials that use sham radiotherapy in their design and review them to determine its potential value. The Cochrane Library, Pubmed and a Reference Search served as data sources. Trials were included if they met a minimum quality score of 3 on a validated assessment instrument (which assesses randomization, control and blinding) and if they compared sham radiotherapy to active treatment. External beam therapy and brachytherapy trials were considered. Twenty-six trials were identified, collectively including 2663 participants in the period of 1970-2004. All the trials studied the value of radiotherapy for treatment or prevention of benign diseases, including multiple sclerosis, coronary artery restenosis, age-related macular degeneration and Graves' ophthalmopathy. There were no trials relating to the use of radiotherapy in the treatment of malignancy. This review showed that it is possible to carry out sham radiotherapy with due regard for ethical concerns, with effective blinding and high levels of patient acceptance. Large sample sizes with multicentre trial designs were achievable. Although the statistical philosophy for using sham radiotherapy in trials is legitimate, it is no longer routinely used.

  3. Implementation of the NCI’s National Clinical Trials Network

    Science.gov (United States)

    NCI is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year. The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initia

  4. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida; Tendal, Britta; Hilden, Jørgen; Boutron, Isabelle; Ravaud, Philippe; Brorson, Stig

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  5. Lethal Prostate Cancer in the PLCO Cancer Screening Trial.

    Science.gov (United States)

    Shoag, Jonathan; Mittal, Sameer; Halpern, Joshua A; Scherr, Douglas; Hu, Jim C; Barbieri, Christopher E

    2016-07-01

    The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial randomized men to usual care or annual prostate-specific antigen (PSA) screening for 6 yr and digital rectal examination for 4 yr. This trial found no difference between the intervention and usual care arms of the study in the primary end point of prostate cancer (PCa)-specific mortality. The PLCO trial results have had a major impact on health policy and the rate of PSA screening in the United States. We analyzed the 13-yr screening and outcomes data from the 151 participants who died of PCa in the screening arm of the trial to better understand how randomization to screening failed to prevent PCa death in these men. We found that of these men, 81 (53.6%) either were never screened as part of the trial or had an initial positive screen. Only 17 (11.3%) of those who died reached year 6 of the trial with a PSA <4.0 ng/ml. The men who died in the screening arm were also older at study entry than the average PLCO participant (66 vs 62 yr; p < 0.001). Our analysis should inform the interpretation of the PLCO trial and provide insight into future trial design. PMID:27166670

  6. 21 CFR 886.1415 - Ophthalmic trial lens frame.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic trial lens frame. 886.1415 Section 886.1415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1415 Ophthalmic trial lens frame....

  7. Trial-by-Trial Adaptation of Movements during Mental Practice under Force Field

    Directory of Open Access Journals (Sweden)

    Muhammad Nabeel Anwar

    2013-01-01

    Full Text Available Human nervous system tries to minimize the effect of any external perturbing force by bringing modifications in the internal model. These modifications affect the subsequent motor commands generated by the nervous system. Adaptive compensation along with the appropriate modifications of internal model helps in reducing human movement errors. In the current study, we studied how motor imagery influences trial-to-trial learning in a robot-based adaptation task. Two groups of subjects performed reaching movements with or without motor imagery in a velocity-dependent force field. The results show that reaching movements performed with motor imagery have relatively a more focused generalization pattern and a higher learning rate in training direction.

  8. Spatiotemporal dynamics of random stimuli account for trial-to-trial variability in perceptual decision making.

    Science.gov (United States)

    Park, Hame; Lueckmann, Jan-Matthis; von Kriegstein, Katharina; Bitzer, Sebastian; Kiebel, Stefan J

    2016-01-01

    Decisions in everyday life are prone to error. Standard models typically assume that errors during perceptual decisions are due to noise. However, it is unclear how noise in the sensory input affects the decision. Here we show that there are experimental tasks for which one can analyse the exact spatio-temporal details of a dynamic sensory noise and better understand variability in human perceptual decisions. Using a new experimental visual tracking task and a novel Bayesian decision making model, we found that the spatio-temporal noise fluctuations in the input of single trials explain a significant part of the observed responses. Our results show that modelling the precise internal representations of human participants helps predict when perceptual decisions go wrong. Furthermore, by modelling precisely the stimuli at the single-trial level, we were able to identify the underlying mechanism of perceptual decision making in more detail than standard models. PMID:26752272

  9. African HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North American trials.

    Directory of Open Access Journals (Sweden)

    Nandi Siegfried

    Full Text Available BACKGROUND: Adherence to good methodological quality is necessary to minimise bias in randomised conrolled trials (RCTs. Specific trial characteristics are associated with better trial quality, but no studies to date are specific to HIV/AIDS or African trials. We postulated that location may negatively impact on trial quality in regions where resources are scarce. METHODS: 1 To compare the methodological quality of all HIV/AIDS RCTs conducted in Africa with a random sample of similar trials conducted in North America; 2 To assess whether location is predictive of trial quality. We searched MEDLINE, EMBASE, CENTRAL and LILACS. Eligible trials were 1 randomized, 2 evaluations of preventive or treatment interventions for HIV/AIDS, 3 reported before 2004, and 4 conducted wholly or partly (if multi-centred in Africa or North America. We assessed adequacy of random generation, allocation concealment and masking of assessors. Using univariate and multivariate logistic regression analyses we evaluated the association between location (Africa versus North America and these domains. FINDINGS: The African search yielded 12,815 records, from which 80 trials were identified. The North American search yielded 13,158 records from which 785 trials were identified and a random sample of 114 selected for analysis. African trials were three times more likely than North American trials to report adequate allocation concealment (OR = 3.24; 95%CI: 1.59 to 6.59; p<0.01 and twice as likely to report adequate generation of the sequence (OR = 2.36; 95%CI: 1.20 to 4.67; p = 0.01, after adjusting for other confounding factors. Additional significant factors positively associated with quality were an a priori sample size power calculation, restricted randomization and inclusion of a flow diagram detailing attrition. We did not detect an association between location and outcome assessor masking. CONCLUSIONS: The higher quality of reporting of methodology in African trials is

  10. Trial-by-trial changes in a priori informational value of external cues and subjective expectancies in human auditory attention.

    Directory of Open Access Journals (Sweden)

    Antonio Arjona

    Full Text Available BACKGROUND: Preparatory activity based on a priori probabilities generated in previous trials and subjective expectancies would produce an attentional bias. However, preparation can be correct (valid or incorrect (invalid depending on the actual target stimulus. The alternation effect refers to the subjective expectancy that a target will not be repeated in the same position, causing RTs to increase if the target location is repeated. The present experiment, using the Posner's central cue paradigm, tries to demonstrate that not only the credibility of the cue, but also the expectancy about the next position of the target are changed in a trial by trial basis. Sequences of trials were analyzed. RESULTS: The results indicated an increase in RT benefits when sequences of two and three valid trials occurred. The analysis of errors indicated an increase in anticipatory behavior which grows as the number of valid trials is increased. On the other hand, there was also an RT benefit when a trial was preceded by trials in which the position of the target changed with respect to the current trial (alternation effect. Sequences of two alternations or two repetitions were faster than sequences of trials in which a pattern of repetition or alternation is broken. CONCLUSIONS: Taken together, these results suggest that in Posner's central cue paradigm, and with regard to the anticipatory activity, the credibility of the external cue and of the endogenously anticipated patterns of target location are constantly updated. The results suggest that Bayesian rules are operating in the generation of anticipatory activity as a function of the previous trial's outcome, but also on biases or prior beliefs like the "gambler fallacy".

  11. DO CANCER CLINICAL TRIAL POPULATIONS TRULY REPRESENT CANCER PATIENTS? A COMPARISON OF OPEN CLINICAL TRIALS TO THE CANCER GENOME ATLAS

    Science.gov (United States)

    Geifman, Nophar; Butte, Atul J.

    2016-01-01

    Open clinical trial data offer many opportunities for the scientific community to independently verify published results, evaluate new hypotheses and conduct meta-analyses. These data provide a springboard for scientific advances in precision medicine but the question arises as to how representative clinical trials data are of cancer patients overall. Here we present the integrative analysis of data from several cancer clinical trials and compare these to patient-level data from The Cancer Genome Atlas (TCGA). Comparison of cancer type-specific survival rates reveals that these are overall lower in trial subjects. This effect, at least to some extent, can be explained by the more advanced stages of cancer of trial subjects. This analysis also reveals that for stage IV cancer, colorectal cancer patients have a better chance of survival than breast cancer patients. On the other hand, for all other stages, breast cancer patients have better survival than colorectal cancer patients. Comparison of survival in different stages of disease between the two datasets reveals that subjects with stage IV cancer from the trials dataset have a lower chance of survival than matching stage IV subjects from TCGA. One likely explanation for this observation is that stage IV trial subjects have lower survival rates since their cancer is less likely to respond to treatment. To conclude, we present here a newly available clinical trials dataset which allowed for the integration of patient-level data from many cancer clinical trials. Our comprehensive analysis reveals that cancer-related clinical trials are not representative of general cancer patient populations, mostly due to their focus on the more advanced stages of the disease. These and other limitations of clinical trials data should, perhaps, be taken into consideration in medical research and in the field of precision medicine. PMID:26776196

  12. Convergence Insufficiency Treatment Trial – Attention and Reading Trial (CITT-ART): Design and Methods

    Science.gov (United States)

    Scheiman, Mitchell; Mitchell, G. Lynn; Cotter, Susan A.; Kulp, Marjean; Chase, Christopher; Borsting, Eric; Arnold, Eugene; Denton, Carolyn; Hertle, Richard

    2016-01-01

    Objective To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI). Methods CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are randomized to 16 weeks of office-based vergence/accommodative therapy (OBVAT) or placebo therapy (OBPT), both supplemented with home therapy. The primary outcome measure is the change in the Wechsler Individual Achievement Test-Version 3 (WIAT-III) reading comprehension subtest score. Secondary outcome measures are changes in attention as measured by the Strengths and Weaknesses of Attention (SWAN) as reported by parents and teachers, tests of binocular visual function, and other measures of reading and attention. The long-term effects of treatment are assessed 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups. The study is entering its second year of recruitment. The final results will contribute to a better understanding of the relationship between the treatment of symptomatic CI and its effect on reading and attention. Conclusion The study will provide an evidence base to help parents, eye professionals, educators, and other health care providers make informed decisions as they care for children with CI and reading and attention problems. Results may also generate additional hypothesis and guide the development of other scientific investigations of the relationships between visual disorders and other developmental disorders in children. PMID:26942226

  13. Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis

    OpenAIRE

    Ross, Joseph S.; Mulvey, Gregory K.; Hines, Elizabeth M.; Nissen, Steven E.; Krumholz, Harlan M.

    2009-01-01

    Editors' Summary Background People assume that whenever they are ill, health care professionals will make sure they get the best available treatment. But how do clinicians know which treatment is most appropriate? In the past, clinicians used their own experience to make treatment decisions. Nowadays, they rely on evidence-based medicine—the systematic review and appraisal of the results of clinical trials, studies that investigate the efficacy and safety of medical interventions in people. H...

  14. The HAART cell phone adherence trial (WelTel Kenya1): a randomized controlled trial protocol

    OpenAIRE

    Ball T Blake; Ngugi Elizabeth; Estambale Benson; Nguti Rosemary; Barasa Samson; Karanja Sarah; Habyarimana James; Jack William; Chung Michael; Ritvo Paul; Kariri Antony; Mills Edward J; Lester Richard T; Thabane Lehana; Kimani Joshua

    2009-01-01

    Abstract Background The objectives are to compare the effectiveness of cell phone-supported SMS messaging to standard care on adherence, quality of life, retention, and mortality in a population receiving antiretroviral therapy (ART) in Nairobi, Kenya. Methods and Design A multi-site randomized controlled open-label trial. A central randomization centre provided opaque envelopes to allocate treatments. Patients initiating ART at three comprehensive care clinics in Kenya will be randomized to ...

  15. Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

    OpenAIRE

    Riveros, Carolina; Dechartres, Agnes; Perrodeau, Elodie; Haneef, Romana; Boutron, Isabelle; Ravaud, Philippe

    2013-01-01

    Editors' Summary Background When patients consult a doctor, they expect to be recommended what their doctor believes is the most effective treatment with the fewest adverse effects. To determine which treatment to recommend, clinicians rely on sources that include research studies. Among studies, the best evidence is generally agreed to come from systematic reviews and randomized controlled clinical trials (RCTs), studies that test the efficacy and safety of medical interventions by comparing...

  16. How to Read a Clinical Trial Paper: A Lesson in Basic Trial Statistics

    OpenAIRE

    Govani, Shail M; Peter D.R. Higgins

    2012-01-01

    While the number of clinical trials performed yearly is increasing, the application of these results to individual patients is quite difficult. This article reviews key portions of the process of applying research results to clinical practice. The first step involves defining the study population and determining whether these patients are similar to the patients seen in clinical practice in terms of demographics, disease type, and disease severity. The dropout rate should be compared between ...

  17. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals.

    OpenAIRE

    Carolina Riveros; Agnes Dechartres; Elodie Perrodeau; Romana Haneef; Isabelle Boutron; Philippe Ravaud

    2013-01-01

    Editors' Summary Background When patients consult a doctor, they expect to be recommended what their doctor believes is the most effective treatment with the fewest adverse effects. To determine which treatment to recommend, clinicians rely on sources that include research studies. Among studies, the best evidence is generally agreed to come from systematic reviews and randomized controlled clinical trials (RCTs), studies that test the efficacy and safety of medical interventions by comparing...

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

    OpenAIRE

    Ross, Joseph S.; Mulvey, Gregory K.; Hines, Elizabeth M.; Steven E. Nissen; Krumholz, Harlan M.

    2009-01-01

    Editors' Summary Background People assume that whenever they are ill, health care professionals will make sure they get the best available treatment. But how do clinicians know which treatment is most appropriate? In the past, clinicians used their own experience to make treatment decisions. Nowadays, they rely on evidence-based medicine—the systematic review and appraisal of the results of clinical trials, studies that investigate the efficacy and safety of medical interventions in people. H...

  19. Maximal Usage Trial: An Overview of the Design of Systemic Bioavailability Trial for Topical Dermatological Products

    OpenAIRE

    Bashaw, Edward Dennis; Tran, Doanh C.; Shukla, Chinmay G.; Liu, Xiaomei

    2014-01-01

    Dermatologic diseases can present in varying forms and severity, ranging from the individual lesion and up to almost total skin involvement. Pharmacokinetic assessment of topical drug products has previously been plagued by bioanalytical assay limitations and the lack of a standardized study design. Since the mid-1990's the US Food and Drug Administration has developed and implemented a pharmacokinetic maximal usage trial (MUsT) design to help address these issues. The MUsT design takes into ...

  20. Sexual assault resistance education for university women: study protocol for a randomized controlled trial (SARE trial)

    OpenAIRE

    Senn, Charlene Y; Eliasziw, Misha; Barata, Paula C.; Thurston, Wilfreda E.; Newby-Clark, Ian R.; Radtke, H Lorraine; Hobden, Karen L

    2013-01-01

    Background More than one in six women will be sexually assaulted in their lifetimes, most by men they know. The situation on university campuses is even more startling, with as many as 1 in 4 female students being victims of rape or attempted rape. The associated physical and mental health effects are extensive and the social and economic costs are staggering. The aim of this randomized controlled trial is to determine whether a novel, small-group sexual assault resistance education program c...

  1. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  2. It's never too late to publish an abandoned trial

    Science.gov (United States)

    Shiles, Celia; Sinclair, Julia

    2015-01-01

    It is estimated that half of all trials have never been published which can lead to patients being denied the most effective treatment and being exposed to unnecessary side effects.  Furthermore the trial participants have been misinformed since the trial results have not contributed to the care of future patients. However the non-publication of trials is often not due to a deliberate decision to cover up results.  Commonly in academia it is due to more understandable reasons such as researchers having busy clinical posts, moving onto other more demanding projects, changing research areas or starting a family.  This is called the “file drawer” problem. The examples in this editorial demonstrate that it is possible to go back, even decades later, and make the results available to inform future evidence based medicine.  We call on others to look into their “file drawer” for unpublished trials. PMID:26097695

  3. Clinical trials of antiangiogenic therapy for hepatocellular carcinoma.

    Science.gov (United States)

    Taketomi, Akinobu

    2016-04-01

    Angiogenesis is a promising therapeutic target to inhibit tumor growth. This review summarizes data from clinical trials of antiangiogenic agents in hepatocellular carcinoma. A systematic search of PubMed was performed to identify clinical trials of specific antiangiogenic agents in hepatocellular carcinoma treatment, particularly phase III trials involving treatment guidelines for advanced hepatocellular carcinoma. Sorafenib is the only systemic drug approved for the treatment of advanced hepatocellular carcinoma. Two large-scale, randomized phase III trials using sorafenib involving patients with unresectable HCC showed a significant survival benefit compared with placebo control groups. However, subsequent phase III trials of antiangiogenic agents in hepatocellular carcinoma have failed to improve survival compared with standard treatment protocols using sorafenib. The efficacy of antiangiogenic agents in combination with other drugs, transarterial chemoembolization, and surgical resection is currently being investigated. Future research is expected to optimize antiangiogenic therapies in combination with standard treatment with sorafenib. PMID:26899258

  4. Future Directions for Surgical Trial Designs in Trigeminal Neuralgia.

    Science.gov (United States)

    Zakrzewska, Joanna M; Relton, Clare

    2016-07-01

    Should patients undergo surgical intervention as soon as they receive a diagnosis of trigeminal neuralgia (TN), or should they wait until pharmacologic treatment fails? This article describes some of the challenges encountered in surgical trials for TN, and provides some guidance for future trials in this area. One future direction for TN research is to use the innovative "cohort multiple RCT design," This article describes some of the challenges encountered in surgical trials for TN, and provides some guidance for future trials in this area. One future direction for TN research is to use the innovative "cohort multiple RCT design," which enables multiple trials to be embedded within a single cohort of patients with TN diagnosis, providing an efficient and effective approach to the testing of multiple interventions for TN with each other and with usual care. PMID:27325002

  5. Money and morals: ending clinical trials for financial reasons.

    Science.gov (United States)

    Eaton, Margaret L; Kwon, Brian K; Scott, Christopher Thomas

    2015-01-01

    Too often, biopharmaceutical companies stop their clinical trials solely for financial reasons. In this chapter, we discuss this phenomenon against the backdrop of a 2011 decision by Geron Corporation to abandon its stem cell clinical trial for spinal cord injury (SCI), the preliminary results of which were released in May 2014. We argue that the resultant harms are widespread and are different in nature from the consequences of stopping trials for scientific or medical reasons. We examine the ethical and social effects that arise from such decisions and discuss them in light of ethical frameworks, including duties of individual stakeholders and corporate sponsors. We offer ways that sponsors and clinical sites can ensure that trials are responsibly started, and once started adequately protect the interests of participants. We conclude with recommendations that industry sponsors of clinical trials should adopt in order to advance a collective and patient-centered research ethic. PMID:25062706

  6. Mitigating the Effects of Nonadherence in Clinical Trials.

    Science.gov (United States)

    Shiovitz, Thomas M; Bain, Earle E; McCann, David J; Skolnick, Phil; Laughren, Thomas; Hanina, Adam; Burch, Daniel

    2016-09-01

    Accounting for subject nonadherence and eliminating inappropriate subjects in clinical trials are critical elements of a successful study. Nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects. Inappropriate subjects (including those who do not have the illness under study, fail to report exclusionary conditions, falsely report medication adherence, or participate in concurrent trials) confound safety and efficacy signals. This paper, a product of the International Society for CNS Clinical Trial Methodology (ISCTM) Working Group on Nonadherence in Clinical Trials, explores and models nonadherence in clinical trials and puts forth specific recommendations to identify and mitigate its negative effects. These include statistical analyses of nonadherence data, novel protocol design, and the use of biomarkers, subject registries, and/or medication adherence technologies. PMID:26634893

  7. Sample size determination in clinical trials with multiple endpoints

    CERN Document Server

    Sozu, Takashi; Hamasaki, Toshimitsu; Evans, Scott R

    2015-01-01

    This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clin...

  8. Towards a framework of success factors for clinical trials

    DEFF Research Database (Denmark)

    Buonansegna, Erika; Salomo, Søren; Maier, Anja;

    2012-01-01

    Clinical trials in the pharmaceutical industry are the most critical part of the drug development process with respect to obtaining the market approval from the authorities. Clinical trials are highly expensive, time-consuming and often unsuccessful. While new product development (NPD) literature...... clinical trials reducing failures and increasing profits. The framework directs managerial focus on the most important factors for success and helps managers in decision-making of operational tasks. The framework can also be applied as a checklist for assessing the status of a clinical trial and later as a...... benchmarking tool to compare clinical trial processes. Dependencies among the identified factors seem to exist, thus a set of propositions, can be developed from the success factors and be the basis for future empirical testing....

  9. Surgical trial in traumatic intracerebral hemorrhage (STITCH(Trauma: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gregson Barbara A

    2012-10-01

    Full Text Available Abstract Background Intracranial hemorrhage occurs in over 60% of severe head injuries in one of three types: extradural (EDH; subdural (SDH; and intraparenchymal (TICH. Prompt surgical removal of significant SDH and EDH is established and widely accepted. However, TICH is more common and is found in more than 40% of severe head injuries. It is associated with a worse outcome but the role for surgical removal remains undefined. Surgical practice in the treatment of TICHs differs widely around the world. The aim of early surgery in TICH removal is to prevent secondary brain injury. There have been trials of surgery for spontaneous ICH (including the STICH II trial, but none so far of surgery for TICH. Methods/Design The UK National Institutes of Health Research has funded STITCH(Trauma to determine whether a policy of early surgery in patients with TICH improves outcome compared to a policy of initial conservative treatment. It will include a health economics component and carry out a subgroup analysis of patients undergoing invasive monitoring. This is an international multicenter pragmatic randomized controlled trial. Patients are eligible if: they are within 48 h of injury; they have evidence of TICH on CT scan with a confluent volume of attenuation significantly raised above that of the background white and grey matter that has a total volume >10 mL; and their treating neurosurgeon is in equipoise. Patients will be ineligible if they have: a significant surface hematoma (EDH or SDH requiring surgery; a hemorrhage/contusion located in the cerebellum; three or more separate hematomas fulfilling inclusion criteria; or severe pre-existing physical or mental disability or severe co-morbidity which would lead to poor outcome even if the patient made a full recovery from the head injury. Patients will be randomized via an independent service. Patients randomized to surgery receive surgery within 12 h. Both groups will be monitored according to

  10. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  11. Reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses

    DEFF Research Database (Denmark)

    Kjaergard, L L; Villumsen, J; Gluud, C

    2001-01-01

    To explore whether reported methodologic quality affects estimated intervention effects in randomized trials and contributes to discrepancies between the results of large randomized trials and small randomized trials in meta-analyses....

  12. Escritas de luz: Der Prozess/ The Trial

    Directory of Open Access Journals (Sweden)

    Michael Löwy

    2015-02-01

    Full Text Available ResumoLiteratura e cinema constituem duas linguagens distintas, irredutíveis. Suas gramáticas, léxicos e sintaxes são radicalmente diferentes. Toda imagem, e a fortiori toda sucessão de imagens, é necessariamente, inevitavelmente, “infiel”ao texto. No seu filme The trial, Orson Welles apropriou-se do romance de Kafka — O processo — para recriá-lo nos seus próprios termos. O romance não exprime uma mensagem política ou doutrinária; mas, sobretudo, um certo estado de espírito antiautoritário. Reencontramos, sob uma outra forma,e com outros meios estéticos, esse mesmo estado de espírito no filme.AbstractLiterature and cinema are two distinct and irreducible languages. Their grammar, vocabulary and syntax are radically different. All image, and more so any succession ofimages is necessarily, inevitably, “unfaithful” to the text. Inhis movie The trial Orson Welles took possession of Kafka’s novel Der Prozess and re-created it in his own terms. The novel does not express a political or doctrinaire message, but rather a certain anti-authoritarian state of mind. One finds, in a different form, and with other aesthetic means, the samestate of mind in the movie.ResuméeLittérature et cinéma constituent deux langages distincts, irréductibles. Leur grammaire, leur lexique, leur syntaxe sont radicalement différents. Toute image, et à fortiori toute succession d’images est nécessairement,  inévitablement, “ infidèle ” au texte. Dans son film The trial Orson Welles s’est approprié du roman de Kafka — Le procès — pour le récréer dans ses propres termes. Le roman n’exprime pas un message politique ou doctrinaire, mais plutôt un certain état d’esprit anti-autoritaire. On retrouve, sous une autreforme, et avec d’autres moyens esthétiques, ce même état d’esprit dans le film.Michael Löwy é um sociólogo nascido no Brasil, formado em Ciências Sociais na Universidade de S

  13. The Ecologic Validity of Fructose Feeding Trials: Supraphysiological Feeding of Fructose in Human Trials Requires Careful Consideration When Drawing Conclusions on Cardiometabolic Risk

    OpenAIRE

    Choo, Vivian L.; John L Sievenpiper

    2015-01-01

    Background Select trials of fructose overfeeding have been used to implicate fructose as a driver of cardiometabolic risk. Objective We examined temporal trends of fructose dose in human controlled feeding trials of fructose and cardiometabolic risk. Methods We combined studies from eight meta-analyses on fructose and cardiometabolic risk to assess the average fructose dose used in these trials. Two types of trials were identified: (1) substitution trials, in which energy f...

  14. The ecologic validity of fructose feeding trials: Supraphysiological feeding of fructose in human trials requires careful consideration when drawing conclusions on cardiometabolic risk

    OpenAIRE

    Choo, Vivian L.; John L Sievenpiper

    2015-01-01

    Background: Select trials of fructose overfeeding have been used to implicate fructose as a driver of cardiometabolic risk.Objective: We examined temporal trends of fructose dose in human controlled feeding trials of fructose and cardiometabolic risk.Methods: We combined studies from eight meta-analyses on fructose and cardiometabolic risk to assess the average fructose dose used in these trials. Two types of trials were identified: 1) substitution trials, in which energy from fructose was e...

  15. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial

    OpenAIRE

    Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

    2014-01-01

    Objective To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Design Cohort embedded pragmatic randomized controlled trial. Setting Trials registered on ClinicalTrials.gov. Participants 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails s...

  16. The K-trial. A 33-years study of the connections between manuring, soils and crops

    OpenAIRE

    Kjellenberg, Lars; Granstedt, Artur

    2005-01-01

    In 1958 started a comparative fertilization trial, called the K-trial, within the frames of Scandinavian Research Circle for Biodynamic Agriculture. The trial ended in 1990. This report accounts for the results that have been collected over this 33-year long trial-period. The ambition with the trial was to develop methods of analyses that could indicate foodstuff quality. The long-term trial-period also brought along, a possibility to study the correlation of fertilization, soil and crop....

  17. Is religiosity related to attitudes toward clinical trials participation?

    Science.gov (United States)

    Daverio-Zanetti, Svetlana; Schultz, Kathryn; del Campo, Miguel A Martin; Malcarne, Vanessa; Riley, Natasha; Sadler, Georgia Robins

    2015-06-01

    Research indicates that a low percentage of cancer patients enroll in cancer clinical trials. This is especially true among minority groups such as Hispanic Americans. Considering the importance of religion in the Hispanic American community, it is important to understand its relationship to perceptions of clinical trials. Five hundred and three Latina women completed the Barriers to Clinical Trials Participation Scale and the Duke University Religion Index. For the total sample, higher organizational and intrinsic religiosity was significantly associated with a perceived lack of community support for clinical trials participation. In subgroup analysis, the relationship between organizational religiosity and lack of support was stronger among Latinas who were Spanish language preferred and Latinas who were Catholic. Intrinsic religiosity was associated with mistrust among Spanish language-preferred Latinas, and both organizational and intrinsic religiosities were associated with a lack of familiarity with clinical trials among Christian (non-Catholic) Latinas. These results indicate that religious institutions that serve Latinas may be an effective venue for disseminating clinical trial education programs to improve attitudes toward clinical trials participation. PMID:24953236

  18. Some recommendations for multi-arm multi-stage trials.

    Science.gov (United States)

    Wason, James; Magirr, Dominic; Law, Martin; Jaki, Thomas

    2016-04-01

    Multi-arm multi-stage designs can improve the efficiency of the drug-development process by evaluating multiple experimental arms against a common control within one trial. This reduces the number of patients required compared to a series of trials testing each experimental arm separately against control. By allowing for multiple stages experimental treatments can be eliminated early from the study if they are unlikely to be significantly better than control. Using the TAILoR trial as a motivating example, we explore a broad range of statistical issues related to multi-arm multi-stage trials including a comparison of different ways to power a multi-arm multi-stage trial; choosing the allocation ratio to the control group compared to other experimental arms; the consequences of adding additional experimental arms during a multi-arm multi-stage trial, and how one might control the type-I error rate when this is necessary; and modifying the stopping boundaries of a multi-arm multi-stage design to account for unknown variance in the treatment outcome. Multi-arm multi-stage trials represent a large financial investment, and so considering their design carefully is important to ensure efficiency and that they have a good chance of succeeding. PMID:23242385

  19. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  20. Strategies for dealing with fraud in clinical trials.

    Science.gov (United States)

    Herson, Jay

    2016-02-01

    Research misconduct and fraud in clinical research is an increasing problem facing the scientific community. This problem is expected to increase due to discoveries in central statistical monitoring and with the increase in first-time clinical trial investigators in the increasingly global reach of oncology clinical trials. This paper explores the most common forms of fraud in clinical trials in order to develop offensive and defensive strategies to deal with fraud. The offensive strategies are used when fraud is detected during a trial and the defensive strategies are those design strategies that seek to minimize or eliminate the effect of fraud. This leads to a proposed fraud recovery plan (FRP) that would be specified before the start of a clinical trial and would indicate actions to be taken upon detecting fraud of different types. Statistical/regulatory issues related to fraud include: dropping all patients from a site that committed fraud, or just the fraudulent data (perhaps replacing the latter through imputation); the role of intent-to-treat analysis; effect on a planned interim analysis; effect on stratified analyses and model adjustment when fraud is detected in covariates; effect on trial-wide randomization, etc. The details of a typical defensive strategy are also presented. It is concluded that it is best to follow a defensive strategy and to have an FRP in place to follow if fraud is detected during the trial. PMID:26194810