Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial.

PubMed

Spieth, Peter M; Güldner, Andreas; Uhlig, Christopher; Bluth, Thomas; Kiss, Thomas; Schultz, Marcus J; Pelosi, Paolo; Koch, Thea; Gama de Abreu, Marcelo

2014-05-02

General anesthesia usually requires mechanical ventilation, which is traditionally accomplished with constant tidal volumes in volume- or pressure-controlled modes. Experimental studies suggest that the use of variable tidal volumes (variable ventilation) recruits lung tissue, improves pulmonary function and reduces systemic inflammatory response. However, it is currently not known whether patients undergoing open abdominal surgery might benefit from intraoperative variable ventilation. The PROtective VARiable ventilation trial ('PROVAR') is a single center, randomized controlled trial enrolling 50 patients who are planning for open abdominal surgery expected to last longer than 3 hours. PROVAR compares conventional (non-variable) lung protective ventilation (CV) with variable lung protective ventilation (VV) regarding pulmonary function and inflammatory response. The primary endpoint of the study is the forced vital capacity on the first postoperative day. Secondary endpoints include further lung function tests, plasma cytokine levels, spatial distribution of ventilation assessed by means of electrical impedance tomography and postoperative pulmonary complications. We hypothesize that VV improves lung function and reduces systemic inflammatory response compared to CV in patients receiving mechanical ventilation during general anesthesia for open abdominal surgery longer than 3 hours. PROVAR is the first randomized controlled trial aiming at intra- and postoperative effects of VV on lung function. This study may help to define the role of VV during general anesthesia requiring mechanical ventilation. Clinicaltrials.gov NCT01683578 (registered on September 3 3012).

Analytical Study of E-Learning Resources in National Open University of Nigeria

ERIC Educational Resources Information Center

Ajegbomogun, Fredrick Olatunji; Okunlaya, Rifqah Olufunmilayo Afolake; Alawiye, Mariam Kehinde

2017-01-01

This paper analyses e-learning resources in the National Open University of Nigeria (NOUN) using Abeokuta study center. Survey research method was adopted for this study. A questionnaire was designed and used to collect data for this study. A sample of 150 respondents was randomly selected from the final year students in the six schools of the…

Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial.

PubMed

Kacmarek, Robert M; Villar, Jesús; Sulemanji, Demet; Montiel, Raquel; Ferrando, Carlos; Blanco, Jesús; Koh, Younsuck; Soler, Juan Alfonso; Martínez, Domingo; Hernández, Marianela; Tucci, Mauro; Borges, Joao Batista; Lubillo, Santiago; Santos, Arnoldo; Araujo, Juan B; Amato, Marcelo B P; Suárez-Sipmann, Fernando

2016-01-01

The open lung approach is a mechanical ventilation strategy involving lung recruitment and a decremental positive end-expiratory pressure trial. We compared the Acute Respiratory Distress Syndrome network protocol using low levels of positive end-expiratory pressure with open lung approach resulting in moderate to high levels of positive end-expiratory pressure for the management of established moderate/severe acute respiratory distress syndrome. A prospective, multicenter, pilot, randomized controlled trial. A network of 20 multidisciplinary ICUs. Patients meeting the American-European Consensus Conference definition for acute respiratory distress syndrome were considered for the study. At 12-36 hours after acute respiratory distress syndrome onset, patients were assessed under standardized ventilator settings (FIO2≥0.5, positive end-expiratory pressure ≥10 cm H2O). If Pao2/FIO2 ratio remained less than or equal to 200 mm Hg, patients were randomized to open lung approach or Acute Respiratory Distress Syndrome network protocol. All patients were ventilated with a tidal volume of 4 to 8 ml/kg predicted body weight. From 1,874 screened patients with acute respiratory distress syndrome, 200 were randomized: 99 to open lung approach and 101 to Acute Respiratory Distress Syndrome network protocol. Main outcome measures were 60-day and ICU mortalities, and ventilator-free days. Mortality at day-60 (29% open lung approach vs. 33% Acute Respiratory Distress Syndrome Network protocol, p = 0.18, log rank test), ICU mortality (25% open lung approach vs. 30% Acute Respiratory Distress Syndrome network protocol, p = 0.53 Fisher's exact test), and ventilator-free days (8 [0-20] open lung approach vs. 7 [0-20] d Acute Respiratory Distress Syndrome network protocol, p = 0.53 Wilcoxon rank test) were not significantly different. Airway driving pressure (plateau pressure - positive end-expiratory pressure) and PaO2/FIO2 improved significantly at 24, 48 and 72 hours in patients in open lung approach compared with patients in Acute Respiratory Distress Syndrome network protocol. Barotrauma rate was similar in both groups. In patients with established acute respiratory distress syndrome, open lung approach improved oxygenation and driving pressure, without detrimental effects on mortality, ventilator-free days, or barotrauma. This pilot study supports the need for a large, multicenter trial using recruitment maneuvers and a decremental positive end-expiratory pressure trial in persistent acute respiratory distress syndrome.

Assessing Professional Openness to a Novel Publication Approach.

ERIC Educational Resources Information Center

DeFiore, Roberta M.; Kramer, Thomas J.

In response to criticism of the peer review publication process, a study surveyed a random sample of 600 members of the American Psychological Association (APA) to determine (1) whether professional openness exists regarding the publication of a journal highlighting studies that, due to a difficulty in the experimental procedure, would usually be…

Effectiveness of a Parent Health Report in Increasing Fruit and Vegetable Consumption Among Preschoolers and Kindergarteners.

PubMed

Hunsaker, Sanita L; Jensen, Chad D

2017-05-01

To determine the effectiveness of a parent health report on fruit and vegetable consumption among preschoolers and kindergarteners. Pre-post open design trial and a randomized controlled trial. A university-sponsored preschool and kindergarten. A total of 63 parents of preschool and kindergarten students participated in the pre-post open design trial and 65 parents participated in the randomized controlled trial. Parents in intervention groups were given a parent health report providing information about their child's fruit and vegetable intake as well as recommendations for how to increase their child's fruit and vegetable consumption. Change in fruit and vegetable consumption. Latent growth curve modeling with Bayesian estimation. Vegetable consumption increased by 0.3 servings/d in the open trial and 0.65 servings/d in the randomized trial. Fruit consumption did not increase significantly in either study. Results from both an open trial and a randomized controlled trial suggested that the parent health report may be a beneficial tool to increase vegetable consumption in preschoolers and kindergarteners. Increases in vegetable consumption can lead to the establishment of lifelong habits of healthy vegetable intake and decrease risk for chronic diseases. Copyright © 2017 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Effectiveness of open versus endovascular abdominal aortic aneurysm repair in population settings: A systematic review of statewide databases.

PubMed

Williams, Christopher R; Brooke, Benjamin S

2017-10-01

Patient outcomes after open abdominal aortic aneurysm and endovascular aortic aneurysm repair have been widely reported from several large, randomized, controlled trials. It is not clear whether these trial outcomes are representative of abdominal aortic aneurysm repair procedures performed in real-world hospital settings across the United States. This study was designed to evaluate population-based outcomes after endovascular aortic aneurysm repair versus open abdominal aortic aneurysm repair using statewide inpatient databases and examine how they have helped improve our understanding of abdominal aortic aneurysm repair. A systematic search of MEDLINE, EMBASE, and CINAHL databases was performed to identify articles comparing endovascular aortic aneurysm repair and open abdominal aortic aneurysm repair using data from statewide inpatient databases. This search was limited to studies published in the English language after 1990, and abstracts were screened and abstracted by 2 authors. Our search yielded 17 studies published between 2004 and 2016 that used data from 29 different statewide inpatient databases to compare endovascular aortic aneurysm repair versus open abdominal aortic aneurysm repair. These studies support the randomized, controlled trial results, including a lower mortality associated with endovascular aortic aneurysm repair extended from the perioperative period up to 3 years after operation, as well as a higher complication rate after endovascular aortic aneurysm repair. The evidence from statewide inpatient database analyses has also elucidated trends in procedure volume, patient case mix, volume-outcome relationships, and health care disparities associated with endovascular aortic aneurysm repair versus open abdominal aortic aneurysm repair. Population analyses of endovascular aortic aneurysm repair and open abdominal aortic aneurysm repair using statewide inpatient databases have confirmed short- and long-term mortality outcomes obtained from large, randomized, controlled trials. Moreover, these analyses have allowed us to assess the effect of endovascular aortic aneurysm repair adoption on population outcomes and patient case mix over time. Published by Elsevier Inc.

Melatonin Treatment in Individuals with Intellectual Disability and Chronic Insomnia: A Randomized Placebo-Controlled Study

ERIC Educational Resources Information Center

Braam, W.; Didden, R.; Smits, M.; Curfs, L.

2008-01-01

Background: While several small-number or open-label studies suggest that melatonin improves sleep in individuals with intellectual disabilities (ID) with chronic sleep disturbance, a larger randomized control trial is necessary to validate these promising results. Methods: The effectiveness of melatonin for the treatment of chronic sleep…

Design, objectives, execution and reporting of published open-label extension studies.

PubMed

Megan, Bowers; Pickering, Ruth M; Weatherall, Mark

2012-04-01

Open-label extension (OLE) studies following blinded randomized controlled trials (RCTs) of pharmaceuticals are increasingly being carried out but do not conform to regulatory standards and questions surround the validity of their evidence. OLE studies are usually discussed as a homogenous group, yet substantial differences in study design still meet the definition of an OLE. We describe published papers reporting OLE studies focussing on stated objectives, design, conduct and reporting. A search of Embase and Medline databases for 1996 to July 2008 revealed 268 papers reporting OLE studies that met our eligibility criteria. A random sample of 50 was selected for detailed review. Over 80% of the studies had efficacy stated as an objective. The most common methods of allocation at the start of the OLE were for all RCT participants to switch to one active treatment or for only participants on the new drug to continue, but in three studies all participants were re-randomized at the start of the OLE. Eligibility criteria and other selection factors resulted in on average of 74% of participants in the preceding RCT(s) enrolling in the OLE and only 57% completed it. Published OLE studies do not form a homogenous group with respect to design or retention of participants, and thus the validity of evidence from an OLE should be judged on an individual basis. The term 'open label' suggests bias through lack of blinding, but slippage in relation to the sample randomized in the preceding RCT may be the more important threat to validity. © 2010 Blackwell Publishing Ltd.

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: long-term follow-up of a randomized controlled trial.

PubMed

Hallén, Magnus; Bergenfelz, Anders; Westerdahl, Johan

2008-03-01

We have conducted a randomized controlled trial of totally extraperitoneal hernia repair (TEP) versus tension-free open repair (Lichtenstein repair); we have presented the results previously up to 1 year after the operation. The aim of this study was to compare patient outcome in both groups at a median follow-up of 7.3 years after operation. Of 168 patients included in a prospective, randomized controlled trial designed to compare TEP with an open tension-free technique, 154 patients (92%) answered a questionnaire and 147 patients (88%) were followed up at an outpatient clinic after a minimum of 6 years after operation. Overall, 89% of patients in the TEP group and 95% of patients in the open group reported complete long-term recovery (P = .23). Permanent impaired inguinal sensibility was more common in the open group (P = .004), whereas the proportion of patients with reported testicular pain was higher in the TEP group (P = .003). Three recurrences were found in the TEP group, and 4 recurrences were found in the open group (P = .99). Four patients in the TEP group underwent operations for complications related to the hernia repair (small bowel obstruction, umbilical hernia, testicular pain, and neuralgia). Overall, both groups showed good long-term results with low rates of recurrences. However, the TEP group was associated with a higher proportion of patients with long-term testicular pain, whereas impaired inguinal sensibility was more common in the open group.

Chirp- and random-based coded ultrasonic excitation for localized blood-brain barrier opening

PubMed Central

Kamimura, HAS; Wang, S; Wu, S-Y; Karakatsani, ME; Acosta, C; Carneiro, AAO; Konofagou, EE

2015-01-01

Chirp- and random-based coded excitation methods have been proposed to reduce standing wave formation and improve focusing of transcranial ultrasound. However, no clear evidence has been shown to support the benefits of these ultrasonic excitation sequences in vivo. This study evaluates the chirp and periodic selection of random frequency (PSRF) coded-excitation methods for opening the blood-brain barrier (BBB) in mice. Three groups of mice (n=15) were injected with polydisperse microbubbles and sonicated in the caudate putamen using the chirp/PSRF coded (bandwidth: 1.5-1.9 MHz, peak negative pressure: 0.52 MPa, duration: 30 s) or standard ultrasound (frequency: 1.5 MHz, pressure: 0.52 MPa, burst duration: 20 ms, duration: 5 min) sequences. T1-weighted contrast-enhanced MRI scans were performed to quantitatively analyze focused ultrasound induced BBB opening. The mean opening volumes evaluated from the MRI were 9.38±5.71 mm3, 8.91±3.91 mm3 and 35.47 ± 5.10 mm3 for the chirp, random and regular sonications, respectively. The mean cavitation levels were 55.40±28.43 V.s, 63.87±29.97 V.s and 356.52±257.15 V.s for the chirp, random and regular sonications, respectively. The chirp and PSRF coded pulsing sequences improved the BBB opening localization by inducing lower cavitation levels and smaller opening volumes compared to results of the regular sonication technique. Larger bandwidths were associated with more focused targeting but were limited by the frequency response of the transducer, the skull attenuation and the microbubbles optimal frequency range. The coded methods could therefore facilitate highly localized drug delivery as well as benefit other transcranial ultrasound techniques that use higher pressure levels and higher precision to induce the necessary bioeffects in a brain region while avoiding damage to the surrounding healthy tissue. PMID:26394091

Meta-analysis of laparoscopic versus open repair of perforated peptic ulcer.

PubMed

Antoniou, Stavros A; Antoniou, George A; Koch, Oliver O; Pointner, Rudolph; Granderath, Frank A

2013-01-01

Laparoscopic treatment of perforated peptic ulcer (PPU) has been introduced as an alternative procedure to open surgery. It has been postulated that the minimally invasive approach involves less operative stress and results in decreased morbidity and mortality. We conducted a meta-analysis of randomized trials to test this hypothesis. Medline, EMBASE, and the Cochrane Central Register of Randomized Trials databases were searched, with no date or language restrictions. Our literature search identified 4 randomized trials, with a cumulative number of 289 patients, that compared the laparoscopic approach with open sutured repair of perforated ulcer. Analysis of outcomes did not favor either approach in terms of morbidity, mortality, and reoperation rate, although odds ratios seemed to consistently support the laparoscopic approach. Results did not determine the comparative efficiency and safety of laparoscopic or open approach for PPU. In view of an increased interest in the laparoscopic approach, further randomized trials are considered essential to determine the relative effectiveness of laparoscopic and open repair of PPU.

Meta-analysis of Laparoscopic Versus Open Repair of Perforated Peptic Ulcer

PubMed Central

Antoniou, George A.; Koch, Oliver O.; Pointner, Rudolph; Granderath, Frank A.

2013-01-01

Background and Objectives: Laparoscopic treatment of perforated peptic ulcer (PPU) has been introduced as an alternative procedure to open surgery. It has been postulated that the minimally invasive approach involves less operative stress and results in decreased morbidity and mortality. Methods: We conducted a meta-analysis of randomized trials to test this hypothesis. Medline, EMBASE, and the Cochrane Central Register of Randomized Trials databases were searched, with no date or language restrictions. Results: Our literature search identified 4 randomized trials, with a cumulative number of 289 patients, that compared the laparoscopic approach with open sutured repair of perforated ulcer. Analysis of outcomes did not favor either approach in terms of morbidity, mortality, and reoperation rate, although odds ratios seemed to consistently support the laparoscopic approach. Results did not determine the comparative efficiency and safety of laparoscopic or open approach for PPU. Conclusion: In view of an increased interest in the laparoscopic approach, further randomized trials are considered essential to determine the relative effectiveness of laparoscopic and open repair of PPU. PMID:23743368

Comparison of closed and open methods of pneumoperitonium in laparoscopic cholecystectomy.

PubMed

Akbar, Mohammad; Khan, Ishtiaq Ali; Naveed, Danish; Khattak, Irfanuddin; Zafar, Arshad; Wazir, Muhammad Salim; Khan, Asif Nawaz; Zia-ur-Rehman

2008-01-01

Pneumoperitonium is the first step in laparoscopic surgery including cholecystectomy. Two commonly used methods to create pneumoperitonium are closed and open technique. Both have advantages and disadvantages. The current study was designed to compare these two techniques in terms of safety and time required to complete the procedure. This was a randomized controlled prospective study conducted at Department of Surgery, Ayub Hospital Complex Abbottabad, from 1st June 2007 to 31st May 2008. Randomization was done into two groups randomly using sealed envelopes containing the questionnaire. Seventy envelopes were kept in the cupboard, containing 35 proformas for group A and 35 for group B. An envelope was randomly fetched and opened upon selection of the patient after taking the informed consent. Pneumoperitonium was created by closed technique in group A, and by open technique in group B. Time required for successful pneumoperitonium was calculated in each group. Failure to induce pneumoperitonium was determined for each technique. Time required to close the wounds at completion, total operating time and injuries sustained during induction of pneumoperitonium were compared in both techniques. Out of the total 70 patients included in study, 35 were in group A and 35 in group B. Mean time required for successful pneumoperitonium was 9.17 minutes in group A and 8.11 minutes in group B. Total operating time ranged from 55 minutes to 130 minutes in group A and from 45 minutes to 110 minutes in group B. Mean of total operating time was 78.34 and 67 minutes in group A and B respectively. Mean time needed to close the wound was 9.88 minutes in group A and 4.97 minutes in group B. Failure of technique was noted in three patients in group A while no failure was experienced in group B. In two cases in group A minor complications during creation of pneumoperitonium were observed while in group B no complication occurred. No patient died in the study. We concluded from this study that open technique of pneumoperitonium was, less time consuming and safer than the closed technique.

Atomoxetine and Methylphenidate Treatment in Children with ADHD: The Efficacy, Tolerability and Effects on Executive Functions

ERIC Educational Resources Information Center

Yildiz, Ozlem; Sismanlar, Sahika G.; Memik, Nursu Cakin; Karakaya, Isik; Agaoglu, Belma

2011-01-01

The aim of this study was to compare the safety, efficacy, tolerability, and the effects of atomoxetine and OROS-MPH on executive functions in children with ADHD. This study was an open-label study that only included two medication groups. Children were randomized to open-label atomoxetine or OROS-MPH for 12 weeks. Primary efficacy measures were…

Comparison Between Minimally Invasive and Open Gastrectomy for Gastric Cancer in Europe: A Systematic Review and Meta-analysis.

PubMed

Kostakis, I D; Alexandrou, A; Armeni, E; Damaskos, C; Kouraklis, G; Diamantis, T; Tsigris, C

2017-03-01

We compared laparoscopic and robotic gastrectomies with open gastrectomies and with each other that were held for gastric cancer in Europe. We searched for studies conducted in Europe and published up to 20 February 2015 in the PubMed database that compared laparoscopic or robotic with open gastrectomies for gastric cancer and with each other. We found 18 original studies (laparoscopic vs open: 13; robotic vs open: 3; laparoscopic vs robotic: 2). Of these, 17 were non-randomized trials and only 1 was a randomized controlled trial. Only four studies had more than 50 patients in each arm. No significant differences were detected between minimally invasive and open approaches regarding the number of retrieved lymph nodes, anastomotic leakage, duodenal stump leakage, anastomotic stenosis, postoperative bleeding, reoperation rates, and intraoperative/postoperative mortality. Nevertheless, laparoscopic procedures provided higher overall morbidity rates when compared with open ones, but robotic approaches did not differ from open ones. On the contrary, blood loss was less and hospital stay was shorter in minimally invasive than in open approaches. However, the results were controversial concerning the duration of operations when comparing minimally invasive with open gastrectomies. Additionally, laparoscopic and robotic procedures provided equivalent results regarding resection margins, duodenal stump leakage, postoperative bleeding, intraoperative/postoperative mortality, and length of hospital stay. On the contrary, robotic operations had less blood loss, but lasted longer than laparoscopic ones. Finally, there were relatively low conversion rates in laparoscopic (0%-6.7%) and robotic gastrectomies (0%-5.6%) in most studies. Laparoscopic and robotic gastrectomies may be considered alternative approaches to open gastrectomies for treating gastric cancer. Minimally invasive operations are characterized by less blood loss and shorter hospital stay than open ones. In addition, robotic procedures have less blood loss, but last longer than laparoscopic ones.

Use of an open-loop system to increase physical activity

USDA-ARS?s Scientific Manuscript database

This study evaluated the effectiveness of an open-loop system that reinforces physical activity with TV watching to increase children’s physical activity. Non-overweight, sedentary boys and girls (8-12 y) were randomized to a group that received feedback of activity counts + reinforcement for physic...

Closed-Loop Control Better than Open-Loop Control of Profofol TCI Guided by BIS: A Randomized, Controlled, Multicenter Clinical Trial to Evaluate the CONCERT-CL Closed-Loop System

PubMed Central

Zhang, Xuena; Wu, Anshi; Yao, Shanglong; Xue, Zhanggang; Yue, Yun

2015-01-01

Background The CONCERT-CL closed-loop infusion system designed by VERYARK Technology Co., Ltd. (Guangxi, China) is an innovation using TCI combined with closed-loop controlled intravenous anesthesia under the guide of BIS. In this study we performed a randomized, controlled, multicenter study to compare closed-loop control and open-loop control of propofol by using the CONCERT-CL closed-loop infusion system. Methods 180 surgical patients from three medical centers undergone TCI intravenous anesthesia with propofol and remifentanil were randomly assigned to propofol closed-loop group and propofol opened-loop groups. Primary outcome was global score (GS, GS = (MDAPE+Wobble)/% of time of bispectral index (BIS) 40-60). Secondary outcomes were doses of the anesthetics and emergence time from anesthesia, such as, time to tracheal extubation. Results There were 89 and 86 patients in the closed-loop and opened-loop groups, respectively. GS in the closed-loop groups (22.21±8.50) were lower than that in the opened-loop group (27.19±15.26) (p=0.009). The higher proportion of time of BIS between 40 and 60 was also observed in the closed-loop group (84.11±9.50%), while that was 79.92±13.17% in the opened-loop group, (p=0.016). No significant differences in propofol dose and time of tracheal extubation were observed. The frequency of propofol regulation in the closed-loop group (31.55±9.46 times/hr) was obverse higher than that in the opened-loop group (6.84±6.21 times/hr) (p=0.000). Conclusion The CONCERT-CL closed-loop infusion system can automatically regulate the TCI of propofol, maintain the BIS value in an adequate range and reduce the workload of anesthesiologists better than open-loop system. Trial Registration ChiCTR ChiCTR-OOR-14005551 PMID:25886041

Drain placement can safely be omitted for open partial nephrectomy: Results from a prospective randomized trial.

PubMed

Kriegmair, Maximilian C; Mandel, Philipp; Krombach, Patrick; Dönmez, Hasan; John, Axel; Häcker, Axel; Michel, Maurice S

2016-05-01

To examine the benefit of drain placement during open partial nephrectomy. Overall, 106 patients treated with open partial nephrectomy were enrolled in a prospective randomized trial. Based on the randomization, a drain was placed or omitted. Complications were assessed according to the Clavien classification. Pain level and requirement for analgesics was evaluated according to a customized pattern. There was no significant difference in the two groups regarding age, body mass index, American Society of Anesthesiologists score, tumor size and nephrometry (preoperative aspects and dimensions used for an anatomical classification). In terms of overall and drain-related complications, no advantage of placing a drain could be proven (P = 0.249). Patients with a drain suffered from a significantly higher pain level (P = 0.01) and showed prolonged mobilization (P < 0.001). There was no difference in bowel movements and requirement of additional analgesics (P = 0.347 and 0.11). The results of the study suggest that drain placement during open partial nephrectomy can safely be omitted, even in cases with violation of the collecting system. © 2016 The Japanese Urological Association.

Pilot Study Comparing Closed Versus Open Tracheal Suctioning in Postoperative Neonates and Infants With Complex Congenital Heart Disease.

PubMed

Tume, Lyvonne N; Baines, Paul B; Guerrero, Rafael; Hurley, Margaret A; Johnson, Robert; Kalantre, Atul; Ramaraj, Ram; Ritson, Paul C; Walsh, Laura; Arnold, Philip D

2017-07-01

To determine the hemodynamic effect of tracheal suction method in the first 36 hours after high-risk infant heart surgery on the PICU and to compare open and closed suctioning techniques. Pilot randomized crossover study. Single PICU in United Kingdom. Infants undergoing surgical palliation with Norwood Sano, modified Blalock-Taussig shunt, or pulmonary artery banding in the first 36 hours postoperatively. Infants were randomized to receive open or closed (in-line) tracheal suctioning either for their first or second study tracheal suction in the first 36 hours postoperatively. Twenty-four infants were enrolled over 18 months, 11 after modified Blalock-Taussig shunt, seven after Norwood Sano, and six after pulmonary artery banding. Thirteen patients received the open suction method first followed by the closed suction method second, and 11 patients received the closed suction method first followed by the open suction method second in the first 36 hours after their surgery. There were statistically significant larger changes in heart rate (p = 0.002), systolic blood pressure (p = 0.022), diastolic blood pressure (p = 0.009), mean blood pressure (p = 0.007), and arterial saturation (p = 0.040) using the open suction method, compared with closed suctioning, although none were clinically significant (defined as requiring any intervention). There were no clinically significant differences between closed and open tracheal suction methods; however, there were statistically significant greater changes in some hemodynamic variables with open tracheal suctioning, suggesting that closed technique may be safer in children with more precarious physiology.

Arthroscopic versus mini-open rotator cuff repair: a prospective, randomized study with 24-month follow-up.

PubMed

Zhang, Zhenxiang; Gu, Beibei; Zhu, Wei; Zhu, Lixian; Li, Qingsong

2014-08-01

This prospective, randomized study was performed to evaluate the results of mini-open and arthroscopic rotator cuff repair in a comparative case series of patients followed for 24 months. A total of 125 patients were randomized to mini-open (Group I) or arthroscopic (Group II) rotator cuff repair at the time of surgical intervention. The University of California Los Angeles (UCLA) score, the American Shoulder and Elbow Surgeons (ASES) index, and muscle strength were measured to evaluate the clinical results, while magnetic resonance arthrography was used at 24-month follow-up to investigate the postoperative rotator cuff integrity. Fifty-three patients in Group I and 55 patients in Group II were available for evaluation at 24-month follow-up. At 24-month follow-up, the UCLA score, the ASES index, and muscle strength were statistically significantly increased in both groups postoperatively, while no significant difference was detected between the 2 groups. Intact rotator cuffs were investigated in 42 patients in Group I and 35 in Group II, and there was a significant difference in postoperative structural integrity between the two groups (P < 0.05). When analysis was limited to the patients with full-thickness tear, the muscle strength of the shoulder was significantly better in Group II, and the retearing rate was significantly higher in Group II. Based on the results obtained from this study, it can be indicated that arthroscopic and mini-open rotator cuff repair displayed substantially equal outcomes, except for higher retearing rate in the arthroscopic repair group. While for patients with full-thickness tear, arthroscopic rotator cuff repair displayed better shoulder strength and significantly higher retearing rate as compared to mini-open rotator cuff repair at 24-month follow-up.

A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study).

PubMed

OʼToole, Robert V; Gary, Joshua L; Reider, Lisa; Bosse, Michael J; Gordon, Wade T; Hutson, James; Quinnan, Stephen M; Castillo, Renan C; Scharfstein, Daniel O; MacKenzie, Ellen J

2017-04-01

The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.

Quenched bond randomness: Superfluidity in porous media and the strong violation of universality

DOE Office of Scientific and Technical Information (OSTI.GOV)

Falicov, A.; Berker, A.N.

1997-04-01

The effects of quenched bond randomness are most readily studied with superfluidity immersed in a porous medium. A lattice model for {sup 3}He-{sup 4}He mixtures and incomplete {sup 4}He fillings in aerogel yields the signature effect of bond randomness, namely the conversion of symmetry-breaking first-order phase transitions into second-order phase transitions, the A-line reaching zero temperature, and the elimination of non-symmetry-breaking first-order phase transitions. The model recognizes the importance of the connected nature of aerogel randomness and thereby yields superfluidity at very low {sup 4}He concentrations, a phase separation entirely within the superfluid phase, and the order-parameter contrast between mixturesmore » and incomplete fillings, all in agreement with experiments. The special properties of the helium mixture/aerogel system are distinctly linked to the aerogel properties of connectivity, randomness, and tenuousness, via the additional study of a regularized {open_quote}jungle-gym{close_quotes} aerogel. Renormalization-group calculations indicate that a strong violation of the empirical universality principle of critical phenomena occurs under quenched bond randomness. It is argued that helium/aerogel critical properties reflect this violation and further experiments are suggested. Renormalization-group analysis also shows that, adjoiningly to the strong universality violation (which hinges on the occurrence or non-occurrence of asymptotic strong coupling-strong randomness under resealing), there is a new {open_quotes}hyperuniversality{close_quotes} at phase transitions with asymptotic strong coupling-strong randomness behavior, for example assigning the same critical exponents to random-bond tricriticality and random-field criticality.« less

Laparoscopic Complete Mesocolic Excision versus Open Complete Mesocolic Excision for Transverse Colon Cancer: Long-Term Survival Results of a Prospective Single Centre Non-Randomized Study.

PubMed

Storli, Kristian Eeg; Eide, Geir Egil

2016-01-01

Laparoscopic complete mesocolic excision (CME) used in the treatment of transverse colon cancer has been questioned on the basis of the technical challenges. The aim of this study was to evaluate the medium- and long-term clinical and survival outcomes after laparoscopic and open CME for transverse colon cancer and to compare the 2 approaches. This study was a retrospective non-randomized study of patients with prospectively registered data on open and laparoscopic CME for transverse colon cancer tumour-node-metastasis stages I-III operated on between 2007 and 2014. This was a single-centre study in a community teaching hospital. A total of 56 patients with transverse colon cancer were included, excluding those with tumours in the colonic flexures. The outcome aims were 4-year time to recurrence (TTR) and cancer-specific survival (CSS). Morbidity was also measured. The 4-year TTR was 93.9% in the laparoscopic group and 91.3% in the open group (p = 0.71). The 4-year CSS was 97.0% in the laparoscopic group and 91.3% in the open group (p = 0.42). This was a prospective single-institution study with a small sample size. Results of the study suggest that the laparoscopic CME approach might be the preferred approach for transverse colon cancer, especially regarding its benefits in terms of short-term morbidity, length of stay and oncological outcome. © 2016 S. Karger AG, Basel.

Random unitary evolution model of quantum Darwinism with pure decoherence

NASA Astrophysics Data System (ADS)

Balanesković, Nenad

2015-10-01

We study the behavior of Quantum Darwinism [W.H. Zurek, Nat. Phys. 5, 181 (2009)] within the iterative, random unitary operations qubit-model of pure decoherence [J. Novotný, G. Alber, I. Jex, New J. Phys. 13, 053052 (2011)]. We conclude that Quantum Darwinism, which describes the quantum mechanical evolution of an open system S from the point of view of its environment E, is not a generic phenomenon, but depends on the specific form of input states and on the type of S-E-interactions. Furthermore, we show that within the random unitary model the concept of Quantum Darwinism enables one to explicitly construct and specify artificial input states of environment E that allow to store information about an open system S of interest with maximal efficiency.

A Demonstration Sample for Poetry Education: Poem under the Light of "Poetics of the Open Work"

ERIC Educational Resources Information Center

Afacan, Aydin

2016-01-01

The aim of this study is to provide a demonstration sample for the high school stage under the light of "Poetics of the Open Work" that is considered as a step towards comprehending the qualified poem. In this study, has been built in single group pretest-posttest design. Independent variables are applied to a randomly selected group to…

Randomized Controlled Trial of Video Self-Modeling Following Speech Restructuring Treatment for Stuttering

ERIC Educational Resources Information Center

Cream, Angela; O'Brian, Sue; Jones, Mark; Block, Susan; Harrison, Elisabeth; Lincoln, Michelle; Hewat, Sally; Packman, Ann; Menzies, Ross; Onslow, Mark

2010-01-01

Purpose: In this study, the authors investigated the efficacy of video self-modeling (VSM) following speech restructuring treatment to improve the maintenance of treatment effects. Method: The design was an open-plan, parallel-group, randomized controlled trial. Participants were 89 adults and adolescents who undertook intensive speech…

Corridor Use Predicted from Behaviors at Habitat Boundaries.

PubMed

Haddad, Nick M

1999-02-01

Through empirical studies and simulation, I demonstrate how simple behaviors can be used in lieu of detailed dispersal studies to predict the effects of corridors on interpatch movements. Movement paths of three butterfly species were measured in large (1.64 ha) experimental patches of open habitat, some of which were connected by corridors. Butterflies that "reflected" off boundaries between open patches and the surrounding forest also emigrated from patches through corridors at rates higher than expected from random movement. This was observed for two open-habitat species, Eurema nicippe and Phoebis sennae; however, edges and corridors had no effect on a habitat generalist, Papilio troilus. Behaviorally based simulation models, which departed from correlated random walks only at habitat boundaries, predicted that corridors increase interpatch movement rates of both open-habitat species. Models also predicted that corridors have proportionately greater effects as corridor width increases, that movement rates increase before leveling off as corridor width increases, and that corridor effects decrease as patch size increases. This study suggests that corridors direct movements of habitat-restricted species and that local behaviors may be used to predict the conservation potential of corridors in fragmented landscapes.

Gender Analysis in the Outcomes of a Lifestyle Intervention Among Patients Who Had an Open Heart Surgery.

PubMed

Kadda, Olga; Manginas, Athanasios; Stavridis, George; Balanos, Dimitris; Kotiou, Maria; Panagiotakos, Demosthenes B

2016-01-01

The aim of this study was to evaluate the gender-oriented differences in the outcomes of a lifestyle intervention trial (diet, smoking cessation, and exercise) among patients who had open heart surgery. A randomized, nonblind intervention study was performed on 500 patients who had open heart surgery. Immediately after hospital discharge, 250 patients were randomly allocated lifestyle intervention by receiving oral and written information in the form of a booklet with specific educational information for postoperative rehabilitation. The remaining 250 patients received the regular oral instructions. The applied lifestyle intervention proved to be beneficial only in men as far as quitting smoking (relative risk [RR]: 0.36, confidence interval [CI]: 0.16-0.80; P = .01) and returning to work (RR: 0.35, CI: 0.13-0.92; P = .03) are concerned. For both genders, no significant associations between dietary and physical activity recommendations were observed. Lifestyle nursing intervention immediately after open heart surgery had a beneficial effect on men 1 year after the surgery but not on women. Thus, there is a need for gender-specific studies among women. © The Author(s) 2015.

Eslicarbazepine acetate: its effectiveness as adjunctive therapy in clinical trials and open studies.

PubMed

Shorvon, S D; Trinka, E; Steinhoff, B J; Holtkamp, M; Villanueva, V; Peltola, J; Ben-Menachem, E

2017-03-01

Eslicarbazepine acetate (ESL) is a once-daily antiepileptic drug that is approved as adjunctive therapy in adults with focal-onset seizures. Following oral administration, ESL is rapidly metabolized to its active metabolite, eslicarbazepine, which acts primarily by enhancing slow inactivation of voltage-gated sodium channels. The efficacy and safety/tolerability of ESL in the adjunctive setting were established in a comprehensive Phase III program (n = 1702 randomized patients) and this evidence has been supported by several open studies (n = 864). ESL treatment has demonstrated improvements in health-related quality of life, in both randomized clinical trials and open studies. ESL has also been shown to be usually well tolerated and efficacious when used in the adjunctive setting in elderly patients. The effectiveness of ESL as the only add-on to antiepileptic drug monotherapy has been demonstrated in a multinational study (n = 219), subgroup analyses of which have also shown it to be efficacious and generally well tolerated in patients who had previously not responded to carbamazepine therapy. Open studies have also demonstrated improvements in tolerability in patients switched overnight from oxcarbazepine to ESL. Due to differences in pharmacokinetics, pharmacodynamics, and metabolism, there may be clinical situations in which it is appropriate to consider switching patients from oxcarbazepine or carbamazepine to ESL.

Study Comparing Vein Integrity and Clinical Outcomes in Open Vein Harvesting and 2 Types of Endoscopic Vein Harvesting for Coronary Artery Bypass Grafting: The VICO Randomized Clinical Trial (Vein Integrity and Clinical Outcomes)

PubMed Central

Krishnamoorthy, Bhuvaneswari; Critchley, William R.; Thompson, Alexander J.; Payne, Katherine; Morris, Julie; Venkateswaran, Rajamiyer V.; Caress, Ann L.

2018-01-01

Background Current consensus statements maintain that endoscopic vein harvesting (EVH) should be standard care in coronary artery bypass graft surgery, but vein quality and clinical outcomes have been questioned. The VICO trial (Vein Integrity and Clinical Outcomes) was designed to assess the impact of different vein harvesting methods on vessel damage and whether this contributes to clinical outcomes after coronary artery bypass grafting. Methods In this single-center, randomized clinical trial, patients undergoing coronary artery bypass grafting with an internal mammary artery and with 1 to 4 vein grafts were recruited. All veins were harvested by a single experienced practitioner. We randomly allocated 300 patients into closed tunnel CO2 EVH (n=100), open tunnel CO2 EVH (n=100), and traditional open vein harvesting (n=100) groups. The primary end point was endothelial integrity and muscular damage of the harvested vein. Secondary end points included clinical outcomes (major adverse cardiac events), use of healthcare resources, and impact on health status (quality-adjusted life-years). Results The open vein harvesting group demonstrated marginally better endothelial integrity in random samples (85% versus 88% versus 93% for closed tunnel EVH, open tunnel EVH, and open vein harvesting; P<0.001). Closed tunnel EVH displayed the lowest longitudinal hypertrophy (1% versus 13.5% versus 3%; P=0.001). However, no differences in endothelial stretching were observed between groups (37% versus 37% versus 31%; P=0.62). Secondary clinical outcomes demonstrated no significant differences in composite major adverse cardiac event scores at each time point up to 48 months. The quality-adjusted life-year gain per patient was 0.11 (P<0.001) for closed tunnel EVH and 0.07 (P=0.003) for open tunnel EVH compared with open vein harvesting. The likelihood of being cost-effective, at a predefined threshold of £20 000 per quality-adjusted life-year gained, was 75% for closed tunnel EVH, 19% for open tunnel EVH, and 6% for open vein harvesting. Conclusions Our study demonstrates that harvesting techniques affect the integrity of different vein layers, albeit only slightly. Secondary outcomes suggest that histological findings do not directly contribute to major adverse cardiac event outcomes. Gains in health status were observed, and cost-effectiveness was better with closed tunnel EVH. High-level experience with endoscopic harvesting performed by a dedicated specialist practitioner gives optimal results comparable to those of open vein harvesting. Clinical Trial Registration URL: https://www.isrctn.com. International Standard Randomised Controlled Trial Registry Number: 91485426. PMID:28637880

Randomized clinical trial of remote ischaemic preconditioning versus no preconditioning in the prevention of perioperative myocardial infarction during open surgery for ruptured abdominal aortic aneurysm.

PubMed

Pedersen, T F; Budtz-Lilly, J; Petersen, C N; Hyldgaard, J; Schmidt, J-O; Kroijer, R; Grønholdt, M-L; Eldrup, N

2018-06-01

Remote ischaemic preconditioning (RIPC) has been suggested as a means of protecting vital organs from reperfusion injury during major vascular surgery. This study was designed to determine whether RIPC could reduce the incidence of perioperative myocardial infarction (MI) during open surgery for ruptured abdominal aortic aneurysm (AAA). Secondary aims were to see if RIPC could reduce 30-day mortality, multiple organ failure, acute intestinal ischaemia, acute kidney injury and ischaemic stroke. This randomized, non-blinded clinical trial was undertaken at three vascular surgery centres in Denmark. Patients who had open surgery for ruptured AAA were randomized to intervention with RIPC or control in a 1 : 1 ratio. Postoperative complications and deaths were registered, and ECG and blood samples were obtained daily during the hospital stay. Of 200 patients randomized, 142 (72 RIPC, 70 controls) were included. There was no difference in rates of perioperative MI between the RIPC and control groups (36 versus 43 per cent respectively), or in rates of organ failure. However, in the per-protocol analysis 30-day mortality was significantly reduced in the RIPC group (odds ratio 0·46, 95 per cent c.i. 0·22 to 0·99; P = 0·048). RIPC did not reduce the incidence of perioperative MI in patients undergoing open surgery for ruptured AAA. Registration number: NCT00883363 ( http://www.clinicaltrials.gov).

A Multicenter, Rater-Blinded, Randomized Controlled Study of Auditory Processing-Focused Cognitive Remediation Combined With Open-Label Lurasidone in Patients With Schizophrenia and Schizoaffective Disorder.

PubMed

Kantrowitz, Joshua T; Sharif, Zafar; Medalia, Alice; Keefe, Richard S E; Harvey, Philip; Bruder, Gerard; Barch, Deanna M; Choo, Tse; Lee, Seonjoo; Lieberman, Jeffrey A

2016-06-01

Small-scale studies of auditory processing cognitive remediation programs have demonstrated efficacy in schizophrenia. We describe a multicenter, rater-blinded, randomized, controlled study of auditory-focused cognitive remediation, conducted from June 24, 2010, to June 14, 2013, and approved by the local institutional review board at all sites. Prior to randomization, participants with schizophrenia (DSM-IV-TR) were stabilized on a standardized antipsychotic regimen (lurasidone [40-160 mg/d]), followed by randomization to adjunctive cognitive remediation: auditory focused (Brain Fitness) versus control (nonspecific video games), administered 1-2 times weekly for 30 sessions. Coprimary outcome measures included MATRICS Consensus Cognitive Battery (MCCB) and the University of California, San Diego, Performance-Based Skills Assessment-Brief scale. 120 participants were randomized and completed at least 1 auditory-focused cognitive remediation (n = 56) or video game control session (n = 64). 74 participants completed ≥ 25 sessions and postrandomization assessments. At study completion, the change from prestabilization was statistically significant for MCCB composite score (d = 0.42, P < .0001) across groups. Participants randomized to auditory-focused cognitive remediation had a trend-level higher mean MCCB composite score compared to participants randomized to control cognitive remediation (P = .08). After controlling for scores at the time of randomization, there were no significant between-treatment group differences at study completion. Auditory processing cognitive remediation combined with lurasidone did not lead to differential improvement over nonspecific video games. Across-group improvement from prestabilization baseline to study completion was observed, but since all participants were receiving lurasidone open label, it is difficult to interpret the source of these effects. Future studies comparing both pharmacologic and behavioral cognitive enhancers should consider a 2 × 2 design, using a control for both the medication and the cognitive remediation. ClinicalTrials.gov identifier: NCT01173874. © Copyright 2016 Physicians Postgraduate Press, Inc.

Open Quantum Random Walks on the Half-Line: The Karlin-McGregor Formula, Path Counting and Foster's Theorem

NASA Astrophysics Data System (ADS)

Jacq, Thomas S.; Lardizabal, Carlos F.

2017-11-01

In this work we consider open quantum random walks on the non-negative integers. By considering orthogonal matrix polynomials we are able to describe transition probability expressions for classes of walks via a matrix version of the Karlin-McGregor formula. We focus on absorbing boundary conditions and, for simpler classes of examples, we consider path counting and the corresponding combinatorial tools. A non-commutative version of the gambler's ruin is studied by obtaining the probability of reaching a certain fortune and the mean time to reach a fortune or ruin in terms of generating functions. In the case of the Hadamard coin, a counting technique for boundary restricted paths in a lattice is also presented. We discuss an open quantum version of Foster's Theorem for the expected return time together with applications.

The nursing and financial implications of laparoscopic colorectal surgery: data from a randomized controlled trial.

PubMed

Norwood, M G A; Stephens, J H; Hewett, P J

2011-11-01

The issue of cost effectiveness of laparoscopic surgery remains uncertain and its impact on the ward nursing staff is unaddressed. This study investigated these issues using patients from a single centre admitted to a randomized controlled trial. All patients recruited into the Australasian Laparoscopic Colon Cancer Study (ALCCaS) from The Queen Elizabeth Hospital between January 1999 and March 2005 were included in this study. Data relating to hospital cost were collated from the Hospital Patient Costing System. Nursing interventions were calculated in minutes per patient, using the excelcare Software database. Data from 97 patients were analysed (laparoscopy, 53; open surgery, 44). The median number of hours of nursing input per patient was 80 (27.5-907) h in the open surgery group and 58.5 (15-684.5) h in the laparoscopy group. This difference was further increased after exclusion of patients converted from laparoscopy to open surgery. The median total cost of the procedure was AUS $9698/£ 5631 (AUS $3862-90,397) in the open surgery group and AUS $10,951/£ 6219 (AUS$2337-66,237) in the laparoscopy group. These data suggest that laparoscopic colorectal surgery is equivalent in price to open surgery and there may be added benefits in reduced nursing intensity. © 2011 The Authors. Colorectal Disease © 2011 The Association of Coloproctology of Great Britain and Ireland.

Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder: A Randomized Clinical Trial.

PubMed

Hudson, James I; McElroy, Susan L; Ferreira-Cornwell, M Celeste; Radewonuk, Jana; Gasior, Maria

2017-09-01

The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. To assess lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults met DSM-IV-R binge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions-Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase. Lisdexamfetamine administration. The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events. Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized lisdexamfetamine responders (placebo, n = 138; lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37; P < .001) for time to relapse; the hazard ratio, based on a Cox proportional hazards model for lisdexamfetamine vs placebo, was 0.09 (95% CI, 0.04-0.23). The treatment-emergent adverse events observed were generally consistent with the known profile of lisdexamfetamine. Risk of binge-eating relapse over 6 months was lower in participants continuing lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with lisdexamfetamine than placebo. clinicaltrials.gov Identifier: NCT02009163.

Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study.

PubMed

Yao, James C; Pavel, Marianne; Lombard-Bohas, Catherine; Van Cutsem, Eric; Voi, Maurizio; Brandt, Ulrike; He, Wei; Chen, David; Capdevila, Jaume; de Vries, Elisabeth G E; Tomassetti, Paola; Hobday, Timothy; Pommier, Rodney; Öberg, Kjell

2016-11-10

Purpose Everolimus improved median progression-free survival by 6.4 months in patients with advanced pancreatic neuroendocrine tumors (NET) compared with placebo in the RADIANT-3 study. Here, we present the final overall survival (OS) data and data on the impact of biomarkers on OS from the RADIANT-3 study. Methods Patients with advanced, progressive, low- or intermediate-grade pancreatic NET were randomly assigned to everolimus 10 mg/day (n = 207) or placebo (n = 203). Crossover from placebo to open-label everolimus was allowed on disease progression. Ongoing patients were unblinded after final progression-free survival analysis and could transition to open-label everolimus at the investigator's discretion (extension phase). OS analysis was performed using a stratified log-rank test in the intent-to-treat population. The baseline levels of chromogranin A, neuron-specific enolase, and multiple soluble angiogenic biomarkers were determined and their impact on OS was explored. Results Of 410 patients who were enrolled between July 2007 and March 2014, 225 received open-label everolimus, including 172 patients (85%) randomly assigned initially to the placebo arm. Median OS was 44.0 months (95% CI, 35.6 to 51.8 months) for those randomly assigned to everolimus and 37.7 months (95% CI, 29.1 to 45.8 months) for those randomly assigned to placebo (hazard ratio, 0.94; 95% CI, 0.73 to 1.20; P = .30). Elevated baseline chromogranin A, neuron-specific enolase, placental growth factor, and soluble vascular endothelial growth factor receptor 1 levels were poor prognostic factors for OS. The most common adverse events included stomatitis, rash, and diarrhea. Conclusion Everolimus was associated with a median OS of 44 months in patients with advanced, progressive pancreatic NET, the longest OS reported in a phase III study for this population. Everolimus was associated with a survival benefit of 6.3 months, although this finding was not statistically significant. Crossover of patients likely confounded the OS results.

[Hyaluronate sodium treatment for internal derangement of temporomandibular joint: a systematic review based on randomized controlled trials].

PubMed

Li, Chunjie; Zhang, Yifan; Jia, Yuanyuan; Lü, Jun; Li, Longjiang; Shi, Zong-Dao

2011-10-01

To assess the efficacy and safety of hyaluronate sodium (HS) for internal derangement of temporomandibular joint by means of systematic review on relevant randomized controlled trials. After identifing the study question of the efficacy and safety of HS for internal derangement of temporomandibular joint, Medline, Cochrane Controlled Trials Register, EMBASE, OPEN SIGLE and CBM were searched electronically till October 3rd 2010. Hand-searching covering 19 dental journals in Chinese were also performed. Risk of bias assessment, with Cochrane Collaboration's tool, and data extraction of included studies were conducted by two reviewers in duplicate. Meta analysis was done with Revman 5.0.23 and the quality of evidence was evaluated by GRADE. 10 randomized controlled trials met the eligibility criteria and were included. All these studies had unclear risk of bias. When compared with negative control, HS showed a significant advantage on maximal mouth opening in short and long-term (P < 0.05), and clinical overall assessment in short-term (P < 0.05), but its effect on pain control and long-term effect on clinical overall assessment had no extra benefit (P > 0.05). Additionally, when compared with glucocorticoids, the participants who received HS injection would get a better clinical overall assessment in short-term and less adverse drug reactions (P < 0.05), but presented a similar temporomandibular joint pain relief and maximal mouth opening (P > 0.05). To a certain extent, HS had good efficacy and better safety than controls when treating internal derangement of temporomandibular joint. However, as the quality of some included studies were limited, more randomized controlled trials are needed to reinforce the conclusion.

A randomized trial of transanal hemorrhoidal dearterialization with anopexy compared with open hemorrhoidectomy in the treatment of hemorrhoids.

PubMed

Elmér, Solveig E; Nygren, Jonas O; Lenander, Claes E

2013-04-01

Doppler guidance in hemorrhoidal surgery has become more frequent during the past decade. The method is mainly studied in nonrandomized trials. Data from randomized controlled trials are lacking. The aim of this study was to compare early and midterm results of transanal hemorrhoidal dearterialization with anopexy to open hemorrhoidectomy. DESIGN, SETTINGS, PATIENTS, AND INTERVENTIONS: Forty patients with grade 2 to 3 hemorrhoids were randomly assigned to transanal hemorrhoidal dearterialization with anopexy (group A, n = 20) or open hemorrhoidectomy (group B, n = 20). A diary was used during the first 2 postoperative weeks. A self-reported symptom questionnaire was answered, and a clinical examination was performed preoperatively, after 2 to 4 months, and after 1 year. The main outcome measure was postoperative pain. Postoperative peak pain was lower in group A during the first week than in group B (p < 0.05), whereas no difference in overall pain was noted. More patients expressed normal well-being in group A (p = 0.045). Pain, bleeding, and the need for manual reduction of the hemorrhoids were all improved in both groups after 1 year (p < 0.05). Soiling had decreased after both methods at early follow-up. After 1 year, soiling was significantly decreased only after open hemorrhoidectomy. The grade of hemorrhoids was significantly reduced after 1 year for both methods, but there was a trend to more patients with remaining grade 2 hemorrhoids in group A (p = 0.06). There was no blinding, the sample size was small, and follow-up was for only 1 year. The questionnaire was not validated. The difference in postoperative pain between transanal hemorrhoidal dearterialization with anopexy and open hemorrhoidectomy may be less than expected based on previous literature.

AUPress: A Comparison of an Open Access University Press with Traditional Presses

ERIC Educational Resources Information Center

McGreal, Rory; Chen, Nian-Shing

2011-01-01

This study is a comparison of AUPress with three other traditional (non-open access) Canadian university presses. The analysis is based on the rankings that are correlated with book sales on Amazon.com and Amazon.ca. Statistical methods include the sampling of the sales ranking of randomly selected books from each press. The results of one-way…

The Treatment of Adolescent Suicide Attempters Study (TASA): Predictors of Suicidal Events in an Open Treatment Trial

ERIC Educational Resources Information Center

Brent, David A.; Greenhill, Laurence L.; Compton, Scott; Emslie, Graham; Wells, Karen; Walkup, John T.; Vitiello, Benedetto; Bukstein, Oscar; Stanley, Barbara; Posner, Kelly; Kennard, Betsy D.; Cwik, Mary F.; Wagner, Ann; Coffey, Barbara; March, John S.; Riddle, Mark; Goldstein, Tina; Curry, John; Barnett, Shannon; Capasso, Lisa; Zelazny, Jamie; Hughes, Jennifer; Shen, Sa; Gugga, S. Sonia; Turner, J. Blake

2009-01-01

Objective: To identify the predictors of suicidal events and attempts in adolescent suicide attempters with depression treated in an open treatment trial. Method: Adolescents who had made a recent suicide attempt and had unipolar depression (n =124) were either randomized (n = 22) or given a choice (n = 102) among three conditions. Two…

Measuring Link-Resolver Success: Comparing 360 Link with a Local Implementation of WebBridge

ERIC Educational Resources Information Center

Herrera, Gail

2011-01-01

This study reviewed link resolver success comparing 360 Link and a local implementation of WebBridge. Two methods were used: (1) comparing article-level access and (2) examining technical issues for 384 randomly sampled OpenURLs. Google Analytics was used to collect user-generated OpenURLs. For both methods, 360 Link out-performed the local…

Open quantum random walks: Bistability on pure states and ballistically induced diffusion

NASA Astrophysics Data System (ADS)

Bauer, Michel; Bernard, Denis; Tilloy, Antoine

2013-12-01

Open quantum random walks (OQRWs) deal with quantum random motions on a line for systems with internal and orbital degrees of freedom. The internal system behaves as a quantum random gyroscope coding for the direction of the orbital moves. We reveal the existence of a transition, depending on OQRW moduli, in the internal system behaviors from simple oscillations to random flips between two unstable pure states. This induces a transition in the orbital motions from the usual diffusion to ballistically induced diffusion with a large mean free path and large effective diffusion constant at large times. We also show that mixed states of the internal system are converted into random pure states during the process. We touch upon possible experimental realizations.

The efficacy of gum chewing in reducing postoperative ileus: a multisite randomized controlled trial.

PubMed

Forrester, David Anthony Tony; Doyle-Munoz, Janet; McTigue, Toni; D'Andrea, Stephanie; Natale-Ryan, Angela

2014-01-01

The purpose of this prospective, attention-controlled, randomized study was to determine whether postoperative gum chewing reduces the duration of postoperative ileus symptoms following elective open or laparoscopic sigmoid colectomy when compared with standard care or an attention-control intervention. Forty-seven subjects scheduled for either an open or laparoscopic colon resection participated in the study. Subjects were recruited preoperatively at the preadmission learning centers of the 2 acute care medical centers that comprised the study settings. Subjects were randomized to 3 groups: (1) standard postoperative care (n = 18); (2) standard care and a silicone-adhesive patch applied to the deltoid region of the upper arm as an attention control (n = 16); and (3) standard care and gum chewing (n = 13). Standard postoperative care included removal of the nasogastric tube, early ambulation, nothing by mouth with ice chips only until the first passage of flatus, and then advancement of diet until tolerance of solid food. No statistically significant differences were found among the 3 study groups for the 4 postoperative outcome variables measured: (1) first passage of flatus; (2) first bowel movement; (3) return of hunger; and (4) ability to tolerate solid food for one meal. Postoperative gum chewing was not found to be more effective than standard postoperative care or our attention-control intervention in reducing the duration of postoperative ileus symptoms, length of stay, or complications among patients following open/laparoscopic sigmoid colectomy.

Unblinded randomized control trial on prophylactic antibiotic use in gustilo II open tibia fractures at Kenyatta National Hospital, Kenya.

PubMed

Ondari, Joshua Nyaribari; Masika, Moses Muia; Ombachi, Richard Bwana; Ating'a, John Ernest

2016-10-01

To determine the difference in infection rate between 24h versus five days of prophylactic antibiotic use in management of Gustilo II open tibia fractures. Unblinded randomized control trial. Accident and Emergency, orthopedic wards and outpatient clinics at Kenyatta National Hospital (KNH). The study involved patients aged 18-80 years admitted through accident and emergency department with Gustilo II traumatic open tibia fractures. Patients were randomized into either 24hour or five day group and antibiotics started for 24hours or five days after surgical debridement. The wounds were exposed and scored using ASEPSIS wound scoring system for infection after 48h, 5days and at 14days. The main outcomes of interest were presence of infection at days 2, 5 and 14 and effect of duration to antibiotic administration on infection rate. There was no significant difference in infection rates between 24-hour and 5-day groups with infection rates of 23% (9/40) vs. 19% (7/37) respectively (p=0.699). The infection rate was significantly associated with time lapsed before administration of antibiotics (p=0.004). In the use of prophylactic antibiotics for the management of Gustilo II traumatic open tibia fractures, there is no difference in infection rate between 24hours and five days regimen but time to antibiotic administration correlates with infection rate. Antibiotic use for 24hours only has proven adequate prophylaxis against infection. This is underlined in our study which we hope shall inform practice in our setting. A larger, more appropriately controlled study would be useful. Copyright © 2016 Elsevier Ltd. All rights reserved.

The effect of aortic morphology on peri-operative mortality of ruptured abdominal aortic aneurysm.

PubMed

2015-06-01

To investigate whether aneurysm shape and extent, which indicate whether a patient with ruptured abdominal aortic aneurysm (rAAA) is eligible for endovascular repair (EVAR), influence the outcome of both EVAR and open surgical repair. The influence of six morphological parameters (maximum aortic diameter, aneurysm neck diameter, length and conicality, proximal neck angle, and maximum common iliac diameter) on mortality and reinterventions within 30 days was investigated in rAAA patients randomized before morphological assessment in the Immediate Management of the Patient with Rupture: Open Versus Endovascular strategies (IMPROVE) trial. Patients with a proven diagnosis of rAAA, who underwent repair and had their admission computerized tomography scan submitted to the core laboratory, were included. Among 458 patients (364 men, mean age 76 years), who had either EVAR (n = 177) or open repair (n = 281) started, there were 155 deaths and 88 re-interventions within 30 days of randomization analysed according to a pre-specified plan. The mean maximum aortic diameter was 8.6 cm. There were no substantial correlations between the six morphological variables. Aneurysm neck length was shorter in those undergoing open repair (vs. EVAR). Aneurysm neck length (mean 23.3, SD 16.1 mm) was inversely associated with mortality for open repair and overall: adjusted OR 0.72 (95% CI 0.57, 0.92) for each 16 mm (SD) increase in length. There were no convincing associations of morphological parameters with reinterventions. Short aneurysm necks adversely influence mortality after open repair of rAAA and preclude conventional EVAR. This may help explain why observational studies, but not randomized trials, have shown an early survival benefit for EVAR. ISRCTN 48334791. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Randomized clinical trial of laparoscopic versus open repair of the perforated peptic ulcer: the LAMA Trial.

PubMed

Bertleff, Mariëtta J O E; Halm, Jens A; Bemelman, Willem A; van der Ham, Arie C; van der Harst, Erwin; Oei, Hok I; Smulders, J F; Steyerberg, E W; Lange, Johan F

2009-07-01

Laparoscopic surgery has become popular during the last decade, mainly because it is associated with fewer postoperative complications than the conventional open approach. It remains unclear, however, if this benefit is observed after laparoscopic correction of perforated peptic ulcer (PPU). The goal of the present study was to evaluate whether laparoscopic closure of a PPU is as safe as conventional open correction. The study was based on a randomized controlled trial in which nine medical centers from the Netherlands participated. A total of 109 patients with symptoms of PPU and evidence of air under the diaphragm were scheduled to receive a PPU repair. After exclusion of 8 patients during the operation, outcomes were analyzed for laparotomy (n = 49) and for the laparoscopic procedure (n = 52). Operating time in the laparoscopy group was significantly longer than in the open group (75 min versus 50 min). Differences regarding postoperative dosage of opiates and the visual analog scale (VAS) for pain scoring system were in favor of the laparoscopic procedure. The VAS score on postoperative days 1, 3, and 7 was significant lower (P < 0.05) in the laparoscopic group. Complications were equally distributed. Hospital stay was also comparable: 6.5 days in the laparoscopic group versus 8.0 days in the open group (P = 0.235). Laparoscopic repair of PPU is a safe procedure compared with open repair. The results considering postoperative pain favor the laparoscopic procedure.

A Prospective, Randomized, Open-Label, Blinded, Endpoint Study Exploring Platelet Response to Half-Dose Prasugrel and Ticagrelor in Patients with the Acute Coronary Syndrome: HOPE-TAILOR Study.

PubMed

Jin, Cai De; Kim, Moo Hyun; Bang, Junghee; Serebruany, Victor

The optimal dosing of novel oral P2Y12 receptor platelet inhibitors such as prasugrel or ticagrelor is unclear and especially challenging in East Asians. We hypothesize that half-dose prasugrel and ticagrelor may be sufficient for long-term maintenance management in Korean patients with the acute coronary syndrome (ACS) compared with conventional dosages. HOPE-TAILOR (Half Dose of Prasugrel and Ticagrelor in Platelet Response after Acute Coronary Syndromes) is a prospective, randomized, open-label, blinded, endpoint (PROBE) single-center, clinical trial. A total of 100 patients with ACS undergoing drug-eluting stent implantation will be randomly assigned to prasugrel, ticagrelor, or clopidogrel, and the patients in each treatment group will receive 1-month therapy with 100 mg q.d. aspirin plus prasugrel 10 mg q.d., ticagrelor 90 mg b.i.d., or clopidogrel 75 mg q.d., followed by half-dose prasugrel 5 mg q.d. or ticagrelor 45 mg b.i.d. for maintenance treatment but without clopidogrel dose reduction. The primary endpoint will be optimal platelet reactivity 3 months after coronary intervention, defined by VerifyNow Analyzer (PRU: 85-208) and vasodilator-stimulated phosphoprotein P2Y12 flow cytometry assay (platelet reactivity indices: 16-50%). Clinical outcomes will also be assessed, including major efficacy (composite of cardiac death, nonfatal myocardial infarction, repeat revascularization, or stroke) and safety (bleeding ≥2 according to the Bleeding Academic Research Consortium). HOPE-TAILOR is a prospective, randomized, open-label, blinded, endpoint study to explore the efficacy and safety of novel P2Y12 receptor inhibitors administered orally at half the dose in Korean patients with ACS. The results will be available late in 2017. © 2017 S. Karger AG, Basel.

The role of laparoscopic surgery for ulcerative colitis: systematic review with meta-analysis.

PubMed

Wu, Xiao-Jian; He, Xiao-Sheng; Zhou, Xu-Yu; Ke, Jia; Lan, Ping

2010-08-01

Crohn's disease is established in laparoscopic surgery due to partial bowel dissection and low postoperative complication rate. However, laparoscopic surgery for ulcerative colitis remains further discussed even if the trend of minimally invasive technique exists. This study is to figure out how laparoscopic surgery works for ulcerative colitis. Sixteen controlled trials were identified through the search strategy mentioned below. There was only one prospective randomized study among the studies selected. A meta-analysis pooled the outcome effects of laparoscopic surgery and open surgery was performed. Fixed effect model or random effect model was respectively used depending on the heterogeneity test of trials. Postoperative fasting time and postoperative hospital stay were shorter in laparoscopic surgery for ulcerative colitis (-1.37 [-2.15, -0.58], -3.22 [-4.20, -2.24], respectively, P < 0.05). Overall complication rate was higher in open surgery, compared with laparoscopic surgery (54.8% versus 39.3%, P = 0.004). However, duration of laparoscopic surgery for ulcerative colitis was extended compared with open surgery (weighted mean difference 69.29 min, P = 0.04). As to recovery of bowel function, peritoneal abscess, anastomotic leakage, postoperative bowel obstruction, wound infection, blood loss, and mortality, laparoscopic surgery did not show any superiority over open surgery. Re-operation rate was almost even (5.2% versus 7.3%). The whole conversion to open surgery was 4.2%. Laparoscopic surgery for ulcerative colitis was at least as safe as open surgery, even better in postoperative fasting time, postoperative hospital stay, and overall complication rate. However, clinical value of laparoscopic surgery for ulcerative colitis needed further evaluation with more well-designed and long-term follow-up studies.

Health-related quality of life and functional outcomes from a randomized-withdrawal study of long-term lisdexamfetamine dimesylate treatment in children and adolescents with attention-deficit/hyperactivity disorder.

PubMed

Banaschewski, Tobias; Johnson, Mats; Lecendreux, Michel; Zuddas, Alessandro; Adeyi, Ben; Hodgkins, Paul; Squires, Liza A; Coghill, David R

2014-12-01

The stimulant prodrug lisdexamfetamine dimesylate (LDX) is an effective and generally well tolerated treatment for the symptoms of attention-deficit/hyperactivity disorder (ADHD). Positive impacts of LDX on health-related quality of life and functional impairment have previously been demonstrated in a 7-week, randomized, double-blind, placebo-controlled, phase III study in children and adolescents in Europe. Maintenance of these broad benefits, as well as symptomatic control, is a key goal of long-term management of ADHD. Secondary objectives of this multinational study in children and adolescents with ADHD were to assess the long-term maintenance of effectiveness of LDX in improving health-related quality of life and reducing functional impairment, as gauged using the Child Health and Illness Profile-Child Edition: Parent Report Form (CHIP-CE: PRF) and the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P), respectively. Patients aged 6-17 years with diagnosed ADHD and a baseline ADHD Rating Scale IV total score of at least 28 were enrolled from the previous European study and from US sites. Patients who completed an open-label LDX treatment period of at least 26 weeks were randomized (1:1) to continue on their optimized dose of LDX or to switch to placebo for a 6-week, double-blind, withdrawal period. Parents completed CHIP-CE: PRF and WFIRS-P questionnaires at weeks 0, 8 and 26 of the open-label period and at weeks 0 and 6 of the randomized-withdrawal period, or at early termination. The endpoint of each period was defined as the last visit with valid data. Effect sizes were the difference (LDX minus placebo) in least-squares (LS)-mean change from baseline to endpoint divided by root-mean-square error. P values were nominal and not adjusted for multiple comparisons. The open-label and randomized full analysis sets comprised 262 and 153 (LDX n = 76; placebo n = 77) patients, respectively. Mean pretreatment CHIP-CE: PRF T-scores were more than one standard deviation below the normative mean in four of the five domains, and there was significant improvement across all domains from baseline to endpoint of the open-label period. In the randomized-withdrawal period, LS-mean CHIP-CE: PRF T-scores deteriorated in all domains in the placebo group, but not in the LDX group. Compared with placebo, the effect of LDX was significant in the Risk Avoidance (effect size 0.829; p < 0.001), Achievement (0.696; p < 0.001) and Satisfaction (0.636; p < 0.001) domains. Mean pretreatment WFIRS-P scores were lowest in the Family domain and the Learning and School domain. WFIRS-P total score and scores in all domains improved significantly from baseline to endpoint of the open-label period. In the randomized-withdrawal period, LS-mean scores deteriorated in the placebo group but not in the LDX group. Compared with placebo, the effect of LDX was significant in the Family, Learning and School, and Risky Activities domains and in total (effect size 0.908; p < 0.001). Using parent-rated instruments, long-term maintenance of the beneficial effect of LDX in multiple domains of health-related quality of life and functional impairment was demonstrated by comparison of treatment continuation and withdrawal under randomized, double-blind, placebo-controlled conditions.

Does colostomy prevent infection in open blunt pelvic fractures? A systematic review.

PubMed

Lunsjo, Karl; Abu-Zidan, Fikri M

2006-05-01

Open pelvic fracture is a rare injury. Our aim in this study is to systematically review the literature to define when diverting colostomy is indicated to protect the patient from infection in open blunt pelvic fractures. Papers studying open pelvic fractures and the use of colostomy were retrieved through MEDLINE and PUBMED. The papers were critically appraised regarding their methodology and conclusions. Relevant information was combined. The level of evidence for the use of colostomy in open pelvic fractures is very low. All reports are retrospective and no statistical methods have been used to support conclusions drawn. We found no difference in the overall infectious complication rate between the colostomy and noncolostomy groups. There is an assumption that patients with perineal wounds would benefit from colostomy; however, rectal involvement in these injuries was not detailed. The role of colostomy in open blunt pelvic fractures is unresolved and randomized multicenter trials are needed.

Opening Doors to Student Success: A Synthesis of Findings from an Evaluation at Six Community Colleges. Policy Brief

ERIC Educational Resources Information Center

Scrivener, Susan; Coghlan, Erin

2011-01-01

Only one-third of all students who enter community colleges with the intent to earn a degree or certificate actually meet this goal within six years. MDRC launched the Opening Doors Demonstration in 2003--the first large-scale random assignment study in a community college setting--to tackle this problem. Partnering with six community colleges,…

Abriendo Puertas/Opening Doors Parenting Program: Summary Report of Program Implementation and Impacts. Publication #2014-24

ERIC Educational Resources Information Center

Moore, Kristin A.; Caal, Selma; Lawner, Elizabeth K.; Rojas, Angela; Walker, Karen

2014-01-01

Child Trends conducted a random assignment evaluation of the Abriendo Puertas/Opening Doors program, one of the largest programs in the United States working with low-income Latino parents of children ages zero to five. Since it began in 2007, the program has served over 30,000 parents/families in 34 states. The evaluation study examined the…

Effect of reducing indoor air pollution on women's respiratory symptoms and lung function: the RESPIRE Randomized Trial, Guatemala.

PubMed

Smith-Sivertsen, Tone; Díaz, Esperanza; Pope, Dan; Lie, Rolv T; Díaz, Anaite; McCracken, John; Bakke, Per; Arana, Byron; Smith, Kirk R; Bruce, Nigel

2009-07-15

Exposure to household wood smoke from cooking is a risk factor for chronic obstructive lung disease among women in developing countries. The Randomized Exposure Study of Pollution Indoors and Respiratory Effects (RESPIRE) is a randomized intervention trial evaluating the respiratory health effects of reducing indoor air pollution from open cooking fires. A total of 504 rural Mayan women in highland Guatemala aged 15-50 years, all using traditional indoor open fires, were randomized to either receive a chimney woodstove (plancha) or continue using the open fire. Assessments of chronic respiratory symptoms and lung function and individual measurements of carbon monoxide exposure were performed at baseline and every 6 months up to 18 months. Use of a plancha significantly reduced carbon monoxide exposure by 61.6%. For all respiratory symptoms, reductions in risk were observed in the plancha group during follow-up; the reduction was statistically significant for wheeze (relative risk = 0.42, 95% confidence interval: 0.25, 0.70). The number of respiratory symptoms reported by the women at each follow-up point was also significantly reduced by the plancha (odds ratio = 0.7, 95% confidence interval: 0.50, 0.97). However, no significant effects on lung function were found after 12-18 months. Reducing indoor air pollution from household biomass burning may relieve symptoms consistent with chronic respiratory tract irritation.

Influence of finger and mouth action observation on random number generation: an instance of embodied cognition for abstract concepts.

PubMed

Grade, Stéphane; Badets, Arnaud; Pesenti, Mauro

2017-05-01

Numerical magnitude and specific grasping action processing have been shown to interfere with each other because some aspects of numerical meaning may be grounded in sensorimotor transformation mechanisms linked to finger grip control. However, how specific these interactions are to grasping actions is still unknown. The present study tested the specificity of the number-grip relationship by investigating how the observation of different closing-opening stimuli that might or not refer to prehension-releasing actions was able to influence a random number generation task. Participants had to randomly produce numbers after they observed action stimuli representing either closure or aperture of the fingers, the hand or the mouth, or a colour change used as a control condition. Random number generation was influenced by the prior presentation of finger grip actions, whereby observing a closing finger grip led participants to produce small rather than large numbers, whereas observing an opening finger grip led them to produce large rather than small numbers. Hand actions had reduced or no influence on number production; mouth action influence was restricted to opening, with an overproduction of large numbers. Finally, colour changes did not influence number generation. These results show that some characteristics of observed finger, hand and mouth grip actions automatically prime number magnitude, with the strongest effect for finger grasping. The findings are discussed in terms of the functional and neural mechanisms shared between hand actions and number processing, but also between hand and mouth actions. The present study provides converging evidence that part of number semantics is grounded in sensory-motor mechanisms.

Follow-up of colorectal cancer patients after resection with curative intent-the GILDA trial.

PubMed

Grossmann, Erik M; Johnson, Frank E; Virgo, Katherine S; Longo, Walter E; Fossati, Rolando

2004-01-01

Surgery remains the primary treatment of colorectal cancer. Data are lacking to delineate the optimal surveillance strategy following resection. A large-scale multi-center European study is underway to address this issue (Gruppo Italiano di Lavoro per la Diagnosi Anticipata-GILDA). Following primary surgery with curative intent, stratification, and randomization at GILDA headquarters, colon cancer patients are then assigned to a more intensive or less intensive surveillance regimen. Rectal cancer patients undergoing curative resection are similarly randomized, with their follow-up regimens placing more emphasis on detection of local recurrence. Target recruitment for the study will be 1500 patients to achieve a statistical power of 80% (assuming an alpha of 0.05 and a hazard-rate reduction of >24%). Since the trial opened in 1998, 985 patients have been randomized from 41 centers as of February 2004. There were 496 patients randomized to the less intensive regimens, and 489 randomized to the more intensive regimens. The mean duration of follow-up is 14 months. 75 relapses (15%) and 32 deaths (7%) had been observed in the two more intensive follow-up arms, while 64 relapses (13%) and 24 deaths (5%) had been observed in the two less intensive arms as of February 2004. This trial should provide the first evidence based on an adequately powered randomized trial to determine the optimal follow-up strategy for colorectal cancer patients. This trial is open to US centers, and recruitment continues.

Note on coefficient matrices from stochastic Galerkin methods for random diffusion equations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhou Tao, E-mail: tzhou@lsec.cc.ac.c; Tang Tao, E-mail: ttang@hkbu.edu.h

2010-11-01

In a recent work by Xiu and Shen [D. Xiu, J. Shen, Efficient stochastic Galerkin methods for random diffusion equations, J. Comput. Phys. 228 (2009) 266-281], the Galerkin methods are used to solve stochastic diffusion equations in random media, where some properties for the coefficient matrix of the resulting system are provided. They also posed an open question on the properties of the coefficient matrix. In this work, we will provide some results related to the open question.

Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns

PubMed Central

2015-01-01

Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants’ rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants’ considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research. PMID:25993308

Impact of Open Data Policies on Consent to Participate in Human Subjects Research: Discrepancies between Participant Action and Reported Concerns.

PubMed

Cummings, Jorden A; Zagrodney, Jessica M; Day, T Eugene

2015-01-01

Research outlets are increasingly adopting open data policies as a requisite for publication, including studies with human subjects data. We investigated whether open data policies influence participants' rate of consent by randomly assigning participants to view consent forms with and without discussion of open data policies. No participants declined to participate, regardless of condition, nor did rates of drop-out vs. completion vary between conditions. Furthermore, no significant change in potential consent rates was reported when participants were openly asked about the influence of open data policies on their likelihood of consent. However, follow-up analyses indicated possible poor attention to consent forms, consistent with previous research. Moreover, thematic analysis of participants' considerations of open data policy indicated multiple considerations such as concerns regarding confidentiality, anonymity, data security, and study sensitivity. The impact of open data policies on participation raises complex issues at the intersection of ethics and scientific innovation. We conclude by encouraging researchers to consider participants as stakeholders in open data policy and by providing recommendations for open data policies in human subjects research.

The effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment: a prospective, randomized, and controlled study.

PubMed

Fekaj, Enver; Gjata, Arben; Maxhuni, Mehmet

2013-09-22

In patients with obstructive jaundice, multi-organ dysfunction may develop. This trial is a prospective, open-label, randomized, and controlled study with the objective to evaluate the effect of ursodeoxycholic acid in liver functional restoration in patients with obstructive jaundice after endoscopic treatment. The aim of this study is to evaluate the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment. The hypothesis of this trial is that patients with obstructive jaundice, in which will be administered UDCA, in the early phase after endoscopic intervention will have better and faster functional restoration of the liver than patients in the control group.Patients with obstructive jaundice, randomly, will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic procedure and will last fourteen days, and (B) control group.Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamil transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic intervention. This trial is a prospective, open-label, randomized, and controlled study to asses the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice in the early phase after endoscopic treatment.

A Multisite Cluster Randomized Field Trial of Open Court Reading

ERIC Educational Resources Information Center

Borman, Geoffrey D.; Dowling, N. Maritza; Schneck, Carrie

2008-01-01

In this article, the authors report achievement outcomes of a multisite cluster randomized field trial of Open Court Reading 2005 (OCR), a K-6 literacy curriculum published by SRA/McGraw-Hill. The participants are 49 first-grade through fifth-grade classrooms from predominantly minority and poor contexts across the nation. Blocking by grade level…

Efficacy of Lisdexamfetamine in Adults With Moderate to Severe Binge-Eating Disorder

PubMed Central

McElroy, Susan L.; Ferreira-Cornwell, M. Celeste; Radewonuk, Jana; Gasior, Maria

2017-01-01

Importance The ability of pharmacotherapies to prevent relapse and maintain efficacy with long-term treatment in psychiatric conditions is important. Objective To assess lisdexamfetamine dimesylate maintenance of efficacy in adults with moderate to severe binge-eating disorder. Design, Setting, and Participants A multinational, phase 3, double-blind, placebo-controlled, randomized withdrawal study including 418 participants was conducted at 49 clinical research study sites from January 27, 2014, to April 8, 2015. Eligible adults met DSM-IV-R binge-eating disorder criteria and had moderate to severe binge eating disorder (≥3 binge-eating days per week for 14 days before open-label baseline; Clinical Global Impressions−Severity [CGI-S] scores ≥4 [moderate severity] at screening and open-label baseline). Following a 12-week, open-label phase (dose optimization, 4 weeks [lisdexamfetamine dimesylate, 50 or 70 mg]; dose maintenance, 8 weeks), lisdexamfetamine responders (≤1 binge eating day per week for 4 consecutive weeks and CGI-S scores ≤2 at week 12) were randomized to placebo or continued lisdexamfetamine during a 26-week, double-blind, randomized withdrawal phase. Interventions Lisdexamfetamine administration. Main Outcomes and Measures The primary outcome variable, time to relapse (≥2 binge-eating days per week for 2 consecutive weeks and ≥2-point CGI-S score increases from randomized withdrawal baseline), was analyzed using a log-rank test (primary analysis); the analysis was stratified for dichotomized 4-week cessation status. Safety assessments included treatment-emergent adverse events. Results Of the 418 participants enrolled in the open-label phase of the study, 411 (358 [87.1%] women; mean [SD] age, 38.3 [10.4] years) were included in the safety analysis set. Of 275 randomized lisdexamfetamine responders (placebo, n = 138; lisdexamfetamine, n = 137), the observed proportions of participants meeting relapse criteria were 3.7% (5 of 136) for lisdexamfetamine and 32.1% (42 of 131) for placebo. Lisdexamfetamine demonstrated superiority over placebo on the log-rank test (χ21, 40.37; P < .001) for time to relapse; the hazard ratio, based on a Cox proportional hazards model for lisdexamfetamine vs placebo, was 0.09 (95% CI, 0.04-0.23). The treatment-emergent adverse events observed were generally consistent with the known profile of lisdexamfetamine. Conclusions and Relevance Risk of binge-eating relapse over 6 months was lower in participants continuing lisdexamfetamine than in those randomized to placebo. The hazard for relapse was lower with lisdexamfetamine than placebo. Trial Registration clinicaltrials.gov Identifier: NCT02009163 PMID:28700805

The effect of foot reflexology on physiologic parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: A clinical trial study.

PubMed

Ebadi, Abbas; Kavei, Parastoo; Moradian, Seyyed Tayyeb; Saeid, Yaser

2015-08-01

The aim of this study was to investigate the efficacy of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery. This was a double blind three-group randomized controlled trial. Totally, 96 patients were recruited and randomly allocated to the experimental, placebo, and the control groups. Study groups respectively received foot reflexology, simple surface touching, and the routine care of the study setting. Physiological parameters (pulse rate, respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, percutaneous oxygen saturation) and weaning time were measured. The study groups did not differ significantly in terms of physiological parameters (P value > 0.05). However, the length of weaning time in the experimental group was significantly shorter than the placebo and the control groups (P value < 0.05). The study findings demonstrated the efficiency of foot reflexology in shortening the length of weaning time. Copyright © 2015 Elsevier Ltd. All rights reserved.

Randomized Controlled Trial Comparing Open Versus Laparoscopic Placement of a Peritoneal Dialysis Catheter and Outcomes: The CAPD I Trial.

PubMed

van Laanen, Jorinde H H; Cornelis, Tom; Mees, Barend M; Litjens, Elisabeth J; van Loon, Magda M; Tordoir, Jan H M; Peppelenbosch, Arnoud G

2018-01-01

To determine the best operation technique, open versus laparoscopic, for insertion of a peritoneal dialysis (PD) catheter with regard to clinical success. Clinical success was defined as an adequate function of the catheter 2 - 4 weeks after insertion. All patients with end-stage renal disease who were suitable for PD and gave informed consent were randomized for either open surgery or laparoscopic surgery. A previous laparotomy was not considered an exclusion criterion. Laparoscopic placement had the advantage of pre-peritoneal tunneling, the possibility for adhesiolysis, and placement of the catheter under direct vision. Catheter fixation techniques, omentopexy, or other adjunct procedures were not performed. Other measured parameters were in-hospital morbidity and mortality and post-operative infections. Between 2010 and 2016, 95 patients were randomized to this study protocol. After exclusion of 5 patients for various reasons, 44 patients received an open procedure and 46 patients a laparoscopic procedure. Gender, age, body mass index (BMI), hypertension, current hemodialysis, severe heart failure, and previous an abdominal operation were not significantly different between the groups. However, in the open surgery group, fewer patients had a previous median laparotomy compared with the laparoscopic group (6 vs 16 patients; p = 0.027). There was no statistically significant difference in mean operation time (36 ± 24 vs 38 ± 15 minutes) and hospital stay (2.1 ± 2.7 vs 3.1 ± 7.3 days) between the groups. In the open surgery group 77% of the patients had an adequate functioning catheter 2 - 4 weeks after insertion compared with 70% of patients in the laparoscopic group ( p = not significant [NS]). In the open surgery group there was 1 post-operative death (2%) compared with none in the laparoscopic group ( p = NS). The morbidity in both groups was low and not significantly different. In the open surgery group, 2 patients had an exit-site infection and 1 patient had a paramedian wound infection. In the laparoscopic group, 1 patient had a transient cardiac event, 1 patient had intraabdominal bleeding requiring reoperation, and 1 patient had fluid leakage that could be managed conservatively. The survival curve demonstrated a good long-term function of PD. This randomized controlled trial (RCT) comparing open vs laparoscopic placement of PD catheters demonstrates equal clinical success rates between the 2 techniques. Advanced laparoscopic techniques such as catheter fixation techniques and omentopexy might further improve clinical outcome. Copyright © 2018 International Society for Peritoneal Dialysis.

[Where does laparoscopy fit in the treatment of inguinal hernia in 2003?].

PubMed

Gainant, A

2003-06-01

Meta-analysis of randomized studies has clearly shown that prosthetic repair of inguinal hernias decreases the risk of hernia recurrence when compared with herniorraphy without prosthesis; but the optimal route for insertion of the prosthetic patch (laparoscopic versus open inguinal approach) remains in dispute. Meta-analysis of randomized studies comparing laparoscopic with open prosthetic hernia repair suggest that laparoscopy is associated with less post-operative pain (both early and late), a quicker recovery, and earlier return to work. Yet this is at the price of longer operative time and an incidence of rare but potentially severe complications. On the basis of these randomized studies, the ANAES in France and the NICE in England have put forth recommendations which accept the indication for laparoscopic repair in recurrent and bilateral hernias, if done by surgeons experienced in laparoscopic technique. For unilateral hernia in adults, laparoscopic repair has shown no proof of superiority over open prosthetic repair in terms of mortality, morbidity, or recurrence rate. The principal advantage of the laparoscopic approach seems to be improved patient comfort; its disadvantage is higher cost and technical difficulty with a prolonged learning curve. The excess costs of the laparoscopic approach may be compensated by an earlier return to work. At present, the laparoscopic repair of hernias finds its clinical niche in patients with bilateral or recurrent hernias or in patients with unilateral hernia who desire a minimal period of postoperative disability.

Point of data saturation was assessed using resampling methods in a survey with open-ended questions.

PubMed

Tran, Viet-Thi; Porcher, Raphael; Falissard, Bruno; Ravaud, Philippe

2016-12-01

To describe methods to determine sample sizes in surveys using open-ended questions and to assess how resampling methods can be used to determine data saturation in these surveys. We searched the literature for surveys with open-ended questions and assessed the methods used to determine sample size in 100 studies selected at random. Then, we used Monte Carlo simulations on data from a previous study on the burden of treatment to assess the probability of identifying new themes as a function of the number of patients recruited. In the literature, 85% of researchers used a convenience sample, with a median size of 167 participants (interquartile range [IQR] = 69-406). In our simulation study, the probability of identifying at least one new theme for the next included subject was 32%, 24%, and 12% after the inclusion of 30, 50, and 100 subjects, respectively. The inclusion of 150 participants at random resulted in the identification of 92% themes (IQR = 91-93%) identified in the original study. In our study, data saturation was most certainly reached for samples >150 participants. Our method may be used to determine when to continue the study to find new themes or stop because of futility. Copyright © 2016 Elsevier Inc. All rights reserved.

Openness to experience, work experience and patient safety.

PubMed

Chang, Hao-Yuan; Friesner, Daniel; Lee, I-Chen; Chu, Tsung-Lan; Chen, Hui-Ling; Wu, Wan-Er; Teng, Ching-I

2016-11-01

The purpose of this study is to examine how the interaction between nurse openness and work experience is related to patient safety. No study has yet examined the interactions between these, and how openness and work experience jointly impact patient safety. This study adopts a cross-sectional design, using self-reported work experience, perceived time pressure and measures of patient safety, and was conducted in a major medical centre. The sample consisted of 421 full-time nurses from all available units in the centre. Proportionate random sampling was used. Patient safety was measured using the self-reported frequency of common adverse events. Openness was self-rated using items identified in the relevant literature. Nurse openness is positively related to the patient safety construct (B = 0.08, P = 0.03). Moreover, work experience reduces the relation between openness and patient safety (B = -0.12, P < 0.01). The relationship between openness, work experience and patient safety suggests a new means of improving patient care in a health system setting. Nurse managers may enhance patient safety by assessing nurse openness and assigning highly open nurses to duties that make maximum use of that trait. © 2016 John Wiley & Sons Ltd.

Stochastic modelling of a single ion channel: an alternating renewal approach with application to limited time resolution.

PubMed

Milne, R K; Yeo, G F; Edeson, R O; Madsen, B W

1988-04-22

Stochastic models of ion channels have been based largely on Markov theory where individual states and transition rates must be specified, and sojourn-time densities for each state are constrained to be exponential. This study presents an approach based on random-sum methods and alternating-renewal theory, allowing individual states to be grouped into classes provided the successive sojourn times in a given class are independent and identically distributed. Under these conditions Markov models form a special case. The utility of the approach is illustrated by considering the effects of limited time resolution (modelled by using a discrete detection limit, xi) on the properties of observable events, with emphasis on the observed open-time (xi-open-time). The cumulants and Laplace transform for a xi-open-time are derived for a range of Markov and non-Markov models; several useful approximations to the xi-open-time density function are presented. Numerical studies show that the effects of limited time resolution can be extreme, and also highlight the relative importance of the various model parameters. The theory could form a basis for future inferential studies in which parameter estimation takes account of limited time resolution in single channel records. Appendixes include relevant results concerning random sums and a discussion of the role of exponential distributions in Markov models.

Early weaning from incubator and early discharge of preterm infants: randomized clinical trial.

PubMed

Zecca, Enrico; Corsello, Mirta; Priolo, Francesca; Tiberi, Eloisa; Barone, Giovanni; Romagnoli, Costantino

2010-09-01

The goal was to assess the feasibility of earlier weaning from the incubator for preterm infants. This was a prospective, randomized study with preterm infants with birth weights of <1600 g who were admitted to a neonatal subintensive ward. Findings for 47 infants who were transferred from an incubator to an open crib at >1600 g (early transition group) were compared with those for 47 infants who were transferred from an incubator to an open crib at >1800 g (standard transition [ST] group). The primary outcome of the study was length of stay. Secondary outcomes were the number of infants returned to an incubator, the growth velocity in an open crib and during the first week at home, the proportions of breastfeeding at discharge and during the first week at home, and the hospital readmission rate. The length of stay was significantly shorter in the early transition group than in the standard transition group (23.5 vs 33 days; P=.0002). No infants required transfer back to the incubator. Only 1 infant in the standard transition group was readmitted to the hospital during the first week after discharge. Growth velocities and individual amounts of breastfeeding were similar between the 2 groups. In this study, weaning of moderately preterm infants from incubators to open cribs at 1600 g was safe and resulted in earlier discharge.

Use of multi-opening burrow systems by black-footed ferrets

USGS Publications Warehouse

Biggins, Dean E.

2012-01-01

Multi-opening burrow systems constructed by prairie dogs (Cynomys) ostensibly provide escape routes when prairie dogs are pursued by predators capable of entering the burrows, such as black-footed ferrets (Mustela nigripes), or by predators that can rapidly dig into the tunnels, such as American badgers (Taxidea taxus). Because badgers also prey on ferrets, ferrets might similarly benefit from multi-opening burrow systems. Using an air blower, white-tailed prairie dog (Cynomys leucurus) burrow openings were tested for connectivity on plots occupied by black-footed ferrets and on randomly selected plots in Wyoming. Significantly more connected openings were found on ferret-occupied plots than on random plots. Connected openings might be due to modifications by ferrets in response to plugging by prairie dogs, due to selection by ferrets for complex systems with multiple openings that are already unobstructed, or simply due to ferrets lingering at kill sites that were multi-opening systems selected by their prairie dog prey.

Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

PubMed Central

2014-01-01

Background Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann–Whitney test. Results The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck’s disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0–1) and for the shoulder RCTs 3.0 (range 0–5) (p = 0.012). Conclusion Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically performed wrist interventions has been studied in only 4 randomized studies compared to 50 randomized studies of significantly higher quality assessing interventions performed through shoulder arthroscopy. PMID:25059881

Phase Transition for the Large-Dimensional Contact Process with Random Recovery Rates on Open Clusters

NASA Astrophysics Data System (ADS)

Xue, Xiaofeng

2016-12-01

In this paper we are concerned with the contact process with random recovery rates on open clusters of bond percolation on Z^d. Let ξ be a random variable such that P(ξ ≥ 1)=1, which ensures E1/ξ <+∞, then we assign i. i. d. copies of ξ on the vertices as the random recovery rates. Assuming that each edge is open with probability p and the infection can only spread through the open edges, then we obtain that limsup _{d→ +∞}λ _d≤ λ _c=1/pE{1}/{ξ}, where λ _d is the critical value of the process on Z^d, i.e., the maximum of the infection rates with which the infection dies out with probability one when only the origin is infected at t=0. To prove the above main result, we show that the following phase transition occurs. Assuming that lceil log drceil vertices are infected at t=0, where these vertices can be located anywhere, then when the infection rate λ >λ _c, the process survives with high probability as d→ +∞ while when λ <λ _c, the process dies out at time O(log d) with high probability.

Civamide cream 0.075% in patients with osteoarthritis of the knee: a 12-week randomized controlled clinical trial with a longterm extension.

PubMed

Schnitzer, Thomas J; Pelletier, Jean-Pierre; Haselwood, Doug M; Ellison, William T; Ervin, John E; Gordon, Richard D; Lisse, Jeffrey R; Archambault, W Tad; Sampson, Allan R; Fezatte, Heidi B; Phillips, Scott B; Bernstein, Joel E

2012-03-01

To evaluate the safety and efficacy of civamide cream 0.075% for the treatment of osteoarthritis (OA) of the knee. We conducted a 12-week, multicenter, randomized, double-blind study with a 52-week open-label extension. Patients with OA of the knee received either civamide cream 0.075% or a lower dose of civamide cream, 0.01%, as the control. The 3 co-primary endpoints in the double-blind study were the time-weighted average (TWA) of change from baseline to Day 84 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and the Subject Global Evaluation (SGE). In the 52-week open-label extension study, the Osteoarthritis Pain Score and SGE were assessed. A total of 695 patients were randomized to receive civamide cream 0.075% (n = 351) or civamide cream 0.01% (control; n = 344) in the double-blind study. Significance in favor of civamide cream 0.075% was achieved for the TWA for all 3 co-primary efficacy variables: WOMAC pain (p = 0.009), WOMAC physical function (p < 0.001), and SGE (p = 0.008); and at Day 84 for these 3 variables (p = 0.013, p < 0.001, and p = 0.049, respectively). These analyses accounted for significant baseline-by-treatment interactions. In the 52-week open-label extension, efficacy was maintained. Civamide cream 0.075% was well tolerated throughout the studies. These studies demonstrate the efficacy of civamide cream for up to 1 year of continuous use. Civamide cream, with its lack of systemic absorption, does not have the potential for serious systemic toxicity, in contrast to several other OA treatments.

Cost-utility analysis comparing laparoscopic vs open aortobifemoral bypass surgery.

PubMed

Krog, Anne Helene; Sahba, Mehdi; Pettersen, Erik M; Wisløff, Torbjørn; Sundhagen, Jon O; Kazmi, Syed Sh

2017-01-01

Laparoscopic aortobifemoral bypass has become an established treatment option for symptomatic aortoiliac obstructive disease at dedicated centers. Minimally invasive surgical techniques like laparoscopic surgery have often been shown to reduce expenses and increase patients' health-related quality of life. The main objective of our study was to measure quality-adjusted life years (QALYs) and costs after totally laparoscopic and open aortobifemoral bypass. This was a within trial analysis in a larger ongoing randomized controlled prospective multicenter trial, Norwegian Laparoscopic Aortic Surgery Trial. Fifty consecutive patients suffering from symptomatic aortoiliac occlusive disease suitable for aortobifemoral bypass surgery were randomized to either totally laparoscopic (n=25) or open surgical procedure (n=25). One patient dropped out of the study before surgery. We measured health-related quality of life using the EuroQol (EQ-5D-5L) questionnaire at 4 different time points, before surgery and for 6 months during follow-up. We calculated the QALYs gained by using the area under the curve for both groups. Costs were calculated based on prices for surgical equipment, vascular prosthesis and hospital stay. We found a significantly higher increase in QALYs after laparoscopic vs open aortobifemoral bypass surgery, with a difference of 0.07 QALYs, ( p =0.001) in favor of laparoscopic aortobifemoral bypass. The total cost of surgery, equipment and hospital stay after laparoscopic surgery (9,953 €) was less than open surgery (17,260 €), ( p =0.001). Laparoscopic aortobifemoral bypass seems to be cost-effective compared with open surgery, due to an increase in QALYs and lower procedure-related costs.

Cost-utility analysis comparing laparoscopic vs open aortobifemoral bypass surgery

PubMed Central

Krog, Anne Helene; Sahba, Mehdi; Pettersen, Erik M; Wisløff, Torbjørn; Sundhagen, Jon O; Kazmi, Syed SH

2017-01-01

Objectives Laparoscopic aortobifemoral bypass has become an established treatment option for symptomatic aortoiliac obstructive disease at dedicated centers. Minimally invasive surgical techniques like laparoscopic surgery have often been shown to reduce expenses and increase patients’ health-related quality of life. The main objective of our study was to measure quality-adjusted life years (QALYs) and costs after totally laparoscopic and open aortobifemoral bypass. Patients and methods This was a within trial analysis in a larger ongoing randomized controlled prospective multicenter trial, Norwegian Laparoscopic Aortic Surgery Trial. Fifty consecutive patients suffering from symptomatic aortoiliac occlusive disease suitable for aortobifemoral bypass surgery were randomized to either totally laparoscopic (n=25) or open surgical procedure (n=25). One patient dropped out of the study before surgery. We measured health-related quality of life using the EuroQol (EQ-5D-5L) questionnaire at 4 different time points, before surgery and for 6 months during follow-up. We calculated the QALYs gained by using the area under the curve for both groups. Costs were calculated based on prices for surgical equipment, vascular prosthesis and hospital stay. Results We found a significantly higher increase in QALYs after laparoscopic vs open aortobifemoral bypass surgery, with a difference of 0.07 QALYs, (p=0.001) in favor of laparoscopic aortobifemoral bypass. The total cost of surgery, equipment and hospital stay after laparoscopic surgery (9,953 €) was less than open surgery (17,260 €), (p=0.001). Conclusion Laparoscopic aortobifemoral bypass seems to be cost-effective compared with open surgery, due to an increase in QALYs and lower procedure-related costs. PMID:28670132

Constructing high complexity synthetic libraries of long ORFs using in vitro selection

NASA Technical Reports Server (NTRS)

Cho, G.; Keefe, A. D.; Liu, R.; Wilson, D. S.; Szostak, J. W.

2000-01-01

We present a method that can significantly increase the complexity of protein libraries used for in vitro or in vivo protein selection experiments. Protein libraries are often encoded by chemically synthesized DNA, in which part of the open reading frame is randomized. There are, however, major obstacles associated with the chemical synthesis of long open reading frames, especially those containing random segments. Insertions and deletions that occur during chemical synthesis cause frameshifts, and stop codons in the random region will cause premature termination. These problems can together greatly reduce the number of full-length synthetic genes in the library. We describe a strategy in which smaller segments of the synthetic open reading frame are selected in vitro using mRNA display for the absence of frameshifts and stop codons. These smaller segments are then ligated together to form combinatorial libraries of long uninterrupted open reading frames. This process can increase the number of full-length open reading frames in libraries by up to two orders of magnitude, resulting in protein libraries with complexities of greater than 10(13). We have used this methodology to generate three types of displayed protein library: a completely random sequence library, a library of concatemerized oligopeptide cassettes with a propensity for forming amphipathic alpha-helical or beta-strand structures, and a library based on one of the most common enzymatic scaffolds, the alpha/beta (TIM) barrel. Copyright 2000 Academic Press.

The effect of India's total sanitation campaign on defecation behaviors and child health in rural Madhya Pradesh: a cluster randomized controlled trial.

PubMed

Patil, Sumeet R; Arnold, Benjamin F; Salvatore, Alicia L; Briceno, Bertha; Ganguly, Sandipan; Colford, John M; Gertler, Paul J

2014-08-01

Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009), and revisited households 21 months later (February-April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. ClinicalTrials.gov NCT01465204. Please see later in the article for the Editors' Summary.

The Effect of India's Total Sanitation Campaign on Defecation Behaviors and Child Health in Rural Madhya Pradesh: A Cluster Randomized Controlled Trial

PubMed Central

Patil, Sumeet R.; Arnold, Benjamin F.; Salvatore, Alicia L.; Briceno, Bertha; Ganguly, Sandipan; Colford, John M.; Gertler, Paul J.

2014-01-01

Background Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). Methods and Findings We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May–July 2009), and revisited households 21 months later (February–April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%–26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%–15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. Conclusions The intervention led to modest increases in availability of IHLs and even more modest reductions in open defecation. These improvements were insufficient to improve child health outcomes (diarrhea, HCGI, parasite infection, anemia, growth). The results underscore the difficulty of achieving adequately large improvements in sanitation levels to deliver expected health benefits within large-scale rural sanitation programs. Trial Registration ClinicalTrials.gov NCT01465204 Please see later in the article for the Editors' Summary PMID:25157929

Evaluation of open versus closed urine collection systems and development of nosocomial bacteriuria in dogs.

PubMed

Sullivan, Lauren A; Campbell, Vicki L; Onuma, Serene C

2010-07-15

To determine whether use of a closed urine collection system would decrease the incidence of nosocomial bacteriuria in hospitalized dogs, compared with use of an open urine collection system (used, sterile IV bags). Randomized controlled trial. 51 hospitalized dogs requiring indwelling urinary catheterization for >or= 24 hours. Dogs were randomly assigned to an open or closed urine collection system group. A standardized protocol for catheter placement and maintenance was followed for all dogs. A baseline urine sample was collected via cystocentesis for aerobic bacterial culture, with additional urine samples obtained daily from the urine collection reservoir. 27 dogs were assigned to the open urine collection system group, and 24 were assigned to the closed urine collection system group. The incidence of nosocomial bacteriuria in dogs with open urine collection systems (3/27 [11.1%]) was not significantly different from incidence in dogs with closed urine collection systems (2/24 [8.3%]). Median duration of catheterization was 2 days for dogs in both groups; the range was 1 to 7 days for dogs in the open group and 1 to 5 days for dogs in the closed group. Results suggested that for dogs requiring short-term indwelling urinary catheterization, the type of urine collection system (open vs closed) was not associated with likelihood of developing nosocomial bacteriuria. Use of a strict protocol for urinary catheter placement and maintenance was likely key in the low incidence of nosocomial bacteriuria in the present study.

Oromucosal delta9-tetrahydrocannabinol/cannabidiol for neuropathic pain associated with multiple sclerosis: an uncontrolled, open-label, 2-year extension trial.

PubMed

Rog, David J; Nurmikko, Turo J; Young, Carolyn A

2007-09-01

Central neuropathic pain (CNP), pain initiated or caused by a primary lesion or dysfunction of the central nervous system, occurs in ~28% of patients with multiple sclerosis (MS). Delta(9)-Tetrahydrocannabinol/cannabidiol (THC/CBD), an endocannabinoid system modulator, has demonstrated efficacy for up to 4 weeks in randomized controlled trials in the treatment of CNP in patients with MS. The purpose of this extension was to establish long-term tolerability and effectiveness profiles for THC/CBD (Sativex (R), GW Pharmaceuticals plc, Salisbury, United Kingdom) oromucosal spray in CNP associated with MS. This uncontrolled, open-label trial was an indefinite-duration extension of a previously reported 5-week randomized study in patients with MS and CNP. In the initial trial, patients were randomized to placebo or THC/CBD. Patients were only required to maintain their existing analgesia in the randomized study. In the open-label trial they could vary their other analgesia as required. All patients (placebo and THC/CBD) who completed the randomized trial commenced the open-label follow-up on THC/CBD (27 mg/mL: 25 mg/mL). Patients titrated their dosage, maintaining their existing analgesia. The primary end point of the trial was the number, frequency, and type of adverse events (AEs) reported by patients. Secondary end points included changes from baseline in 11-point numerical rating scale (NRS-11) neuropathic pain score, hematology and clinical chemistry test results, vital signs, trial drug usage, and intoxication visual analogue scale scores. Sixty-six patients were enrolled in the randomized trial; 64 (97%) completed the randomized trial and 63 (95%) entered the open-label extension (race, white, 100%; sex, male, 14 [22%]; mean [SD] age, 49 [8.4] years [range, 27-71 years[). The mean (SD) duration of open-label treatment was 463 (378) days (median, 638 days; range, 3-917 days), with 34 (54%) patients completing >1 year of treatment with THC/CBD and 28 (44%) patients completing the open-label trial with a mean (SD) duration of treatment of 839 (42) days (median, 845 days; range, 701-917 days). Mean NRS-11 pain scores in the final week of the randomized trial were 3.8 in the treatment group and 5.0 in the placebo group. In the 28 (44%) patients who completed the 2-year follow up, the mean (SD) NRS-11 pain score in the final week of treatment was 2.9 (2.0) (range, 0-8.0). Fifty-eight (92%) patients experienced > or =1 treatment-related AE. These AEs were rated by the investigator as mild in 47 (75%) patients, moderate in 49 (78%), and severe in 32 (51%). The most commonly reported AEs were dizziness (27%), nausea (18 %), and feeling intoxicated (11%). Two treatment-related serious AEs (ventricular bigeminy and circulatory collapse) were judged to be treatment-related. Both serious AEs occurred in the same patient and resolved completely following a period of discontinuation. Eleven (17%) patients experienced oral discomfort, 4 persistently. Regular oral examinations revealed that 7 (11%) patients developed white buccal mucosal patches and 2 (3%) developed red buccal mucosal patches; all cases were deemed mild and resolved. Seventeen (25%) patients withdrew due to AEs. The mean number of sprays and patients experiencing intoxication remained stable throughout the follow-up trial. THC/CBD was effective, with no evidence of tolerance, in these select patients with CNP and MS who completed approximately 2 years of treatment (n = 28). Ninety-two percent of patients experienced an AE, the most common of which were dizziness and nausea. The majority of AEs were deemed to be of mild to moderate severity by the investigators.

Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial.

PubMed

Ferrando, Carlos; Suarez-Sipmann, Fernando; Tusman, Gerardo; León, Irene; Romero, Esther; Gracia, Estefania; Mugarra, Ana; Arocas, Blanca; Pozo, Natividad; Soro, Marina; Belda, Francisco J

2017-01-01

Low tidal volume (VT) during anesthesia minimizes lung injury but may be associated to a decrease in functional lung volume impairing lung mechanics and efficiency. Lung recruitment (RM) can restore lung volume but this may critically depend on the post-RM selected PEEP. This study was a randomized, two parallel arm, open study whose primary outcome was to compare the effects on driving pressure of adding a RM to low-VT ventilation, with or without an individualized post-RM PEEP in patients without known previous lung disease during anesthesia. Consecutive patients scheduled for major abdominal surgery were submitted to low-VT ventilation (6 ml·kg-1) and standard PEEP of 5 cmH2O (pre-RM, n = 36). After 30 min estabilization all patients received a RM and were randomly allocated to either continue with the same PEEP (RM-5 group, n = 18) or to an individualized open-lung PEEP (OL-PEEP) (Open Lung Approach, OLA group, n = 18) defined as the level resulting in maximal Cdyn during a decremental PEEP trial. We compared the effects on driving pressure and lung efficiency measured by volumetric capnography. OL-PEEP was found at 8±2 cmH2O. 36 patients were included in the final analysis. When compared with pre-RM, OLA resulted in a 22% increase in compliance and a 28% decrease in driving pressure when compared to pre-RM. These parameters did not improve in the RM-5. The trend of the DP was significantly different between the OLA and RM-5 groups (p = 0.002). VDalv/VTalv was significantly lower in the OLA group after the RM (p = 0.035). Lung recruitment applied during low-VT ventilation improves driving pressure and lung efficiency only when applied as an open-lung strategy with an individualized PEEP in patients without lung diseases undergoing major abdominal surgery. ClinicalTrials.gov NCT02798133.

Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: a randomized controlled trial†

PubMed Central

Thimour-Bergström, Linda; Roman-Emanuel, Christine; Scherstén, Henrik; Friberg, Örjan; Gudbjartsson, Tomas; Jeppsson, Anders

2013-01-01

OBJECTIVES The incidence of surgical site infection (SSI) after open vein harvesting in coronary artery bypass grafting (CABG) patients ranges in different studies between 2 and 20%. Triclosan is an antibacterial substance that reduces the growth of bacteria by inhibiting fatty acid synthesis. We hypothesized that wound closure with triclosan-coated sutures would reduce SSI after open vein harvesting. METHODS An investigator-initiated prospective randomized double-blind single-centre study was performed with 374 patients, randomized to subcutaneous and intracutaneous leg-wound closure with either triclosan-coated sutures (Vicryl Plus® and Monocryl Plus®, Ethicon, Somerville, NJ, USA) (n = 184) or identical sutures without triclosan (n = 190) from the same manufacturer. All patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). Primary endpoint was SSI within 60 days after surgery according to the definition of Center for Disease Control. Predefined secondary endpoints included culture-proven and antibiotic-treated SSI. RESULTS The primary endpoint occurred in 23 patients (12.5%) with triclosan-coated sutures and in 38 patients (20.0%) in the group without triclosan (P = 0.0497, risk ratio 0.63, (95% confidence interval 0.39–1.00). Corresponding figures for culture-proven infections were 7.6 vs 12.1%, (P = 0.15), and for antibiotic-treated infections, 10.9 vs 18.4%, (P = 0.039). Staphylococcus aureus and coagulase-negative staphylococci were the most common pathogens in both groups. Insulin-treated diabetes and vein-harvesting time were associated with SSI after vein harvesting. CONCLUSIONS Leg-wound closure with triclosan-coated sutures in CABG patients reduces SSIs after open vein harvesting. (ClinicalTrials.gov number NCT01212315). PMID:23435526

Normothermic versus hypothermic cardiopulmonary bypass in children undergoing open heart surgery (thermic-2): study protocol for a randomized controlled trial.

PubMed

Baos, Sarah; Sheehan, Karen; Culliford, Lucy; Pike, Katie; Ellis, Lucy; Parry, Andrew J; Stoica, Serban; Ghorbel, Mohamed T; Caputo, Massimo; Rogers, Chris A

2015-05-25

During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body ("perfusion") while the heart is stopped. Typically the blood is cooled during this procedure ("hypothermia") and warmed to normal body temperature once the operation has been completed. The main rationale for "whole body cooling" is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body's metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery ("normothermia"). However, the two techniques have not been extensively compared in children. The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of genomic expression changes in cardiac tissue biopsies, and neuropsychological development. A total of 141 patients have been successfully randomized over 2 years and 10 months and are now being followed-up for 1 year. Results will be published in 2015. We believe this to be the first large pragmatic study comparing clinical outcomes during normothermic versus hypothermic bypass in complex open heart surgery in children. It is expected that this work will provide important information to improve strategies of cardiopulmonary bypass perfusion and therefore decrease the inevitable organ damage that occurs during nonphysiological body perfusion. ISRCTN Registry: ISRCTN93129502, http://www.isrctn.com/ISRCTN93129502 (Archived by WebCitation at http://www.webcitation.org/6Yf5VSyyG).

Mouth-opening device as a treatment modality in trismus patients with head and neck cancer and oral submucous fibrosis: a prospective study.

PubMed

Li, Yu-Hsuan; Chang, Wei-Chin; Chiang, Tien-En; Lin, Chiun-Shu; Chen, Yuan-Wu

2018-04-26

This study investigated the clinical effectiveness of intervention with an open-mouth exercise device designed to facilitate maximal interincisal opening (MIO) and improve quality of life in patients with head and neck (H&N) cancer and oral submucous fibrosis (OSF). Sixty patients with H&N cancer, OSF, and trismus (MIO < 35 mm) participated in the functional rehabilitation program. An open-mouth exercise device intervention group and conventional group, each consisting of 20 patients, underwent a 12-week training and exercising program and follow-up. For the control group, an additional 20 patients were randomly selected to match the demographic characteristics of the aforementioned two groups. The patients' MIO improvements in the aforementioned three groups were 14.0, 10.5, and 1.3 mm, respectively. Results of this study confirm the significant improvement in average mouth-opening range. In addition, according to patient feedback, significant improvements in health-related quality of life and reductions in trismus symptoms occurred in the open-mouth exercise device group. This newly designed open-mouth exercise device can facilitate trismus patients with H&N cancer and OSF and improve mouth-opening range and quality of life.

Single-dose pharmacokinetic properties of esomeprazole in children aged 1 - 11 years with endoscopically proven GERD: a randomized, open-label study.

PubMed

Youssef, Nader N; Tron, Eduardo; Tolia, Vasundhara; Hamer-Maansson, Jennifer E; Lundborg, Per; Illueca, Marta

2014-11-01

To assess the overall exposure after a single dose of esomeprazole in children with gastroesophageal reflux disease (GERD). Oral esomeprazole administered as an intact capsule with 30 - 180 mL of water, or as an opened capsule mixed with as much as 1 tablespoon of applesauce followed by 30 - 180 mL of water. In this randomized, open-label study of children aged 1 - 11 years with endoscopically proven GERD, patients weighing 8 - < 20 kg were randomized to a single 5- or 10-mg oral dose of esomeprazole, and patients weighing >= 20 kg were randomized to a single 10- or 20-mg oral dose of esomeprazole. Esomeprazole exposure (AUC(0-∞)), AUC from zero to last measurable concentration (AUC(0-t)), maximum plasma concentration (C(max)), time to C(max) (t(max)), terminal-phase half-life, apparent oral clearance, and apparent volume of distribution were determined. 28 patients were randomized to receive esomeprazole: 14 patients weighing 8 to < 20 kg received esomeprazole 5 mg (n = 7) or 10 mg (n = 7), and 14 patients weighing ≥20 kg received esomeprazole 10 mg (n = 6) or 20 mg (n = 8). Children weighing 8 - < 20 kg had a 1.8-fold higher exposure with the 10-mg vs. 5-mg dose (AUC(0-∞), 1.32 vs. 0.73 μmol·h/L, respectively); children weighing ≥ 20 kg had a 4.4-fold higher exposure with the 20-mg vs. 10-mg dose (AUC(0-∞), 3.06 vs. 0.69 μmol·h/L). C(max) was 2.2-fold higher for the 10-mg vs. 5-mg dose (8 to < 20 kg) and 2.4-fold higher for the 20-mg vs.10-mg dose (>= 20 kg). The pharmacokinetics of single-dose esomeprazole were dose-dependent in children weighing >= 20 kg but not in children weighing 8 to < 20 kg.

Open-closed-loop iterative learning control for a class of nonlinear systems with random data dropouts

NASA Astrophysics Data System (ADS)

Cheng, X. Y.; Wang, H. B.; Jia, Y. L.; Dong, YH

2018-05-01

In this paper, an open-closed-loop iterative learning control (ILC) algorithm is constructed for a class of nonlinear systems subjecting to random data dropouts. The ILC algorithm is implemented by a networked control system (NCS), where only the off-line data is transmitted by network while the real-time data is delivered in the point-to-point way. Thus, there are two controllers rather than one in the control system, which makes better use of the saved and current information and thereby improves the performance achieved by open-loop control alone. During the transfer of off-line data between the nonlinear plant and the remote controller data dropout occurs randomly and the data dropout rate is modeled as a binary Bernoulli random variable. Both measurement and control data dropouts are taken into consideration simultaneously. The convergence criterion is derived based on rigorous analysis. Finally, the simulation results verify the effectiveness of the proposed method.

The MANDELA study: A multicenter, randomized, open-label, parallel group trial to refine the use of everolimus after heart transplantation.

PubMed

Deuse, Tobias; Bara, Christoph; Barten, Markus J; Hirt, Stephan W; Doesch, Andreas O; Knosalla, Christoph; Grinninger, Carola; Stypmann, Jörg; Garbade, Jens; Wimmer, Peter; May, Christoph; Porstner, Martina; Schulz, Uwe

2015-11-01

In recent years a series of trials has sought to define the optimal protocol for everolimus-based immunosuppression in heart transplantation, with the goal of minimizing exposure to calcineurin inhibitors (CNIs) and harnessing the non-immunosuppressive benefits of everolimus. Randomized studies have demonstrated that immunosuppressive potency can be maintained in heart transplant patients receiving everolimus despite marked CNI reduction, although very early CNI withdrawal may be inadvisable. A potential renal advantage has been shown for everolimus, but the optimal time for conversion and the adequate reduction in CNI exposure remain to be defined. Other reasons for use of everolimus include a substantial reduction in the risk of cytomegalovirus infection, and evidence for inhibition of cardiac allograft vasculopathy, a major cause of graft loss. The ongoing MANDELA study is a 12-month multicenter, randomized, open-label, parallel-group study in which efficacy, renal function and safety are compared in approximately 200 heart transplant patients. Patients receive CNI therapy, steroids and everolimus or mycophenolic acid during months 3 to 6 post-transplant, and are then randomized at month 6 post-transplant (i) to convert to CNI-free immunosuppression with everolimus and mycophenolic acid or (ii) to continue reduced-exposure CNI, with concomitant everolimus. Patients are then followed to month 18 post-transplant The rationale and expectations for the trial and its methodology are described herein. Copyright © 2015 Elsevier Inc. All rights reserved.

Proximal opening wedge osteotomy with wedge-plate fixation compared with proximal chevron osteotomy for the treatment of hallux valgus: a prospective, randomized study.

PubMed

Glazebrook, Mark; Copithorne, Peter; Boyd, Gordon; Daniels, Timothy; Lalonde, Karl-André; Francis, Patricia; Hickey, Michael

2014-10-01

Hallux valgus with an increased intermetatarsal angle is usually treated with a proximal metatarsal osteotomy. The proximal chevron osteotomy is commonly used but is technically difficult. This study compares the proximal opening wedge osteotomy of the first metatarsal with the proximal chevron osteotomy for the treatment of hallux valgus with an increased intermetatarsal angle. This prospective, randomized multicenter (three-center) study was based on the clinical outcome scores of the Short Form-36, the American Orthopaedic Foot & Ankle Society forefoot questionnaire, and the visual analog scale for pain, activity, and patient satisfaction. Subjects were assessed prior to surgery and at three, six, and twelve months postoperatively. Surgeon preference was evaluated based on questionnaires and the operative times required for each procedure. No significant differences were found for any of the patients' clinical outcome measurements between the two procedures. The proximal opening wedge osteotomy was found to lengthen, and the proximal chevron osteotomy was found to shorten, the first metatarsal. The intermetatarsal angles improved (decreased) significantly, from 14.8° ± 3.2° to 9.1° ± 2.9 (mean and standard deviation) after a proximal opening wedge osteotomy and from 14.6° ± 3.9° to 11.3° ± 4.0° after a proximal chevron osteotomy (p < 0.05 for both). Operative time required for performing a proximal opening wedge osteotomy is similar to that required for performing a proximal chevron osteotomy (mean and standard deviation, 67.1 ± 16.5 minutes compared with 69.9 ± 18.6 minutes; p = 0.510). Opening wedge and proximal chevron osteotomies have comparable radiographic outcomes and comparable clinical outcomes for pain, satisfaction, and function. The proximal opening wedge osteotomy lengthens, and the proximal chevron osteotomy shortens, the first metatarsal. The proximal opening wedge osteotomy was subjectively less technically demanding and was preferred by the orthopaedic surgeons in this study. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.

A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

PubMed

Chandramohan, S M; Gajbhiye, Raj Narenda; Agwarwal, Anil; Creedon, Erin; Schwiers, Michael L; Waggoner, Jason R; Tatla, Daljit

2013-08-01

Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n = 138) and the stapled group (n = 142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6 ± 1.90 min (stapled) and 20.6 ± 1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.

An elevated plus-maze in mixed reality for studying human anxiety-related behavior.

PubMed

Biedermann, Sarah V; Biedermann, Daniel G; Wenzlaff, Frederike; Kurjak, Tim; Nouri, Sawis; Auer, Matthias K; Wiedemann, Klaus; Briken, Peer; Haaker, Jan; Lonsdorf, Tina B; Fuss, Johannes

2017-12-21

A dearth of laboratory tests to study actual human approach-avoidance behavior has complicated translational research on anxiety. The elevated plus-maze (EPM) is the gold standard to assess approach-avoidance behavior in rodents. Here, we translated the EPM to humans using mixed reality through a combination of virtual and real-world elements. In two validation studies, we observed participants' anxiety on a behavioral, physiological, and subjective level. Participants reported higher anxiety on open arms, avoided open arms, and showed an activation of endogenous stress systems. Participants' with high anxiety exhibited higher avoidance. Moreover, open arm avoidance was moderately predicted by participants' acrophobia and sensation seeking, with opposing influences. In a randomized, double blind, placebo controlled experiment, GABAergic stimulation decreased avoidance of open arms while alpha-2-adrenergic antagonism increased avoidance. These findings demonstrate cross-species validity of open arm avoidance as a translational measure of anxiety. We thus introduce the first ecologically valid assay to track actual human approach-avoidance behavior under laboratory conditions.

Photobiomodulation with non-thermal lasers: Mechanisms of action and therapeutic uses in dermatology and aesthetic medicine.

PubMed

Nestor, Mark; Andriessen, Anneke; Berman, Brian; Katz, Bruce E; Gilbert, Dore; Goldberg, David J; Gold, Michael H; Kirsner, Robert S; Lorenc, Paul Z

2017-08-01

Non-thermal laser therapy in dermatology, is a growing field in medical technology by which therapeutic effects are achieved by exposing tissues to specific wavelengths of light. The purpose of this review was to gain a better understanding of the science behind non-thermal laser and the evidence supporting its use in dermatology. A group of dermatologists and surgeons recently convened to review the evidence supporting the use of non-thermal laser for body sculpting, improving the appearance of cellulite, and treating onychomycosis. The use of non-thermal laser for body sculpting is supported by three randomized, double-blind, sham-controlled studies (N = 161), one prospective open-label study (N = 54), and two retrospective studies (N = 775). Non-thermal laser application for improving the appearance of cellulite is supported by one randomized, double-blind, sham-controlled study (N = 38). The use of non-thermal laser for the treatment of onychomycosis is supported by an analysis of three non-randomized, open-label studies demonstrating clinical improvement of nails (N = 292). Non-thermal laser is steadily moving into mainstream medical practice, such as dermatology. Although present studies have demonstrated the safety and efficacy of non-thermal laser for body sculpting, cellulite reduction and onychomycosis treatment, studies demonstrating the efficacy of non-thermal laser as a stand-alone procedure are still inadequate.

Novel core-shell (TiO2@Silica) nanoparticles for scattering medium in a random laser: higher efficiency, lower laser threshold and lower photodegradation.

PubMed

Jimenez-Villar, Ernesto; Mestre, Valdeci; de Oliveira, Paulo C; de Sá, Gilberto F

2013-12-21

There has been growing interest in scattering media in recent years, due to their potential applications as solar collectors, photocatalyzers, random lasers and other novel optical devices. Here, we have introduced a novel core-shell scattering medium for a random laser composed of TiO2@Silica nanoparticles. Higher efficiency, lower laser threshold and long photobleaching lifetime in random lasers were demonstrated. This has introduced a new method or parameter (fraction of absorbed pumping), which opens a new avenue to characterize and study the scattering media. Optical chemical and colloidal stabilities were combined by coating a suitable silica shell onto TiO2 nanoparticles.

Continuous-time quantum random walks require discrete space

NASA Astrophysics Data System (ADS)

Manouchehri, K.; Wang, J. B.

2007-11-01

Quantum random walks are shown to have non-intuitive dynamics which makes them an attractive area of study for devising quantum algorithms for long-standing open problems as well as those arising in the field of quantum computing. In the case of continuous-time quantum random walks, such peculiar dynamics can arise from simple evolution operators closely resembling the quantum free-wave propagator. We investigate the divergence of quantum walk dynamics from the free-wave evolution and show that, in order for continuous-time quantum walks to display their characteristic propagation, the state space must be discrete. This behavior rules out many continuous quantum systems as possible candidates for implementing continuous-time quantum random walks.

Maintenance N-acetyl cysteine treatment for bipolar disorder: a double-blind randomized placebo controlled trial.

PubMed

Berk, Michael; Dean, Olivia M; Cotton, Sue M; Gama, Clarissa S; Kapczinski, Flavio; Fernandes, Brisa; Kohlmann, Kristy; Jeavons, Susan; Hewitt, Karen; Moss, Kirsteen; Allwang, Christine; Schapkaitz, Ian; Cobb, Heidi; Bush, Ashley I; Dodd, Seetal; Malhi, Gin S

2012-08-14

N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493).

Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study.

PubMed

Maduell, Francisco; Moreso, Francesc; Pons, Mercedes; Ramos, Rosa; Mora-Macià, Josep; Foraster, Andreu; Soler, Jordi; Galceran, Josep M; Martinez-Castelao, Alberto

2011-01-01

Retrospective studies showed that online hemodiafiltration (OL-HDF) is associated with a risk reduction of mortality over standard hemodialysis (HD) in patients with end-stage renal disease. Until now, no information was available from prospective randomized clinical trials. A prospective, randomized, multicenter, open study was designed to be conducted in HD units from Catalonia (Spain). The aim of the study is to compare 3-year survival in prevalent end-stage renal disease patients randomized to OL-HDF or to continue on standard HD. The minimum sample size was calculated according to Catalonian mortality of patients on dialysis and assuming a risk reduction associated with OL-HDF of 35% (1-sided p<0.05 and a statistical power of 0.8) and a rate of dropout due to renal transplantation or loss to follow-up of 30%. From May 2007 to September 2008, 906 patients were included and randomized to OL-HDF (n=456) or standard HD (n=450). Demographics and analytical data at the time of randomization were not different between both groups of patients. Patients will be followed during a 3-year period. The present study will contribute to evaluating the benefit for patient survival of OL-HDF over standard HD.

Randomized, Controlled Trial of Therapy Interruption in Chronic HIV-1 Infection

PubMed Central

Papasavvas, Emmanouil; Kostman, Jay R; Mounzer, Karam; Grant, Robert M; Gross, Robert; Gallo, Cele; Azzoni, Livio; Foulkes, Andrea; Thiel, Brian; Pistilli, Maxwell; Mackiewicz, Agnieszka; Shull, Jane; Montaner, Luis J

2004-01-01

Background Approaches to limiting exposure to antiretroviral therapy (ART) drugs are an active area of HIV therapy research. Here we present longitudinal follow-up of a randomized, open-label, single-center study of the immune, viral, and safety outcomes of structured therapy interruptions (TIs) in patients with chronically suppressed HIV-1 infection as compared to equal follow-up of patients on continuous therapy and including a final therapy interruption in both arms. Methods and Findings Forty-two chronically HIV-infected patients on suppressive ART with CD4 counts higher than 400 were randomized 1:1 to either (1) three successive fixed TIs of 2, 4, and 6 wk, with intervening resumption of therapy with resuppression for 4 wk before subsequent interruption, or (2) 40 wk of continuous therapy, with a final open-ended TI in both treatment groups. Main outcome was analysis of the time to viral rebound (>5,000 copies/ml) during the open-ended TI. Secondary outcomes included study-defined safety criteria, viral resistance, therapy failure, and retention of immune reconstitution. There was no difference between the groups in time to viral rebound during the open-ended TI (continuous therapy/single TI, median [interquartile range] = 4 [1–8] wk, n = 21; repeated TI, median [interquartile range] = 5 [4–8] wk, n = 21; p = 0.36). No differences in study-related adverse events, viral set point at 12 or 20 wk of open-ended interruption, viral resistance or therapy failure, retention of CD4 T cell numbers on ART, or retention of lymphoproliferative recall antigen responses were noted between groups. Importantly, resistance detected shortly after initial viremia following the open-ended TI did not result in a lack of resuppression to less than 50 copies/ml after reinitiation of the same drug regimen. Conclusion Cycles of 2- to 6-wk time-fixed TIs in patients with suppressed HIV infection failed to confer a clinically significant benefit with regard to viral suppression off ART. Also, secondary analysis showed no difference between the two strategies in terms of safety, retention of immune reconstitution, and clinical therapy failure. Based on these findings, we suggest that further clinical research on the long-term consequences of TI strategies to decrease drug exposure is warranted. PMID:15630469

Comparison of Wiltse's paraspinal approach and open book laminectomy for thoracolumbar burst fractures with greenstick lamina fractures: a randomized controlled trial.

PubMed

Chen, Zhi-da; Wu, Jin; Yao, Xiao-Tao; Cai, Tao-Yi; Zeng, Wen-Rong; Lin, Bin

2018-03-02

Posterior short-segment pedicle screw fixation is used to treat thoracolumbar burst fractures. However, no randomized controlled studies have compared the efficacy of the two approaches--the Wiltse's paraspinal approach and open book laminectomy in the treatment of thoracolumbar burst fractures with greenstick lamina fractures. Patients with burst fractures of the thoracolumbar spine without neurological deficit were randomized to receive either the Wiltse's paraspinal approach (group A, 24 patients) or open book laminectomy (group B, 23 patients). Patients were followed postoperatively for average of 27.4 months. Clinical and radiographic data of the two approaches were collected and compared. Our results showed the anterior segmental height, kyphotic angle, visual analog scale (VAS) score, and Smiley-Webster Scale (SWS) score significantly improved postoperatively in both groups, indicating that both the Wiltse's paraspinal approach and open book laminectomy can effectively treat thoracolumbar burst fractures with greenstick lamina fractures. The Wiltse's paraspinal approach was found to have significantly shorter operating time, less blood loss, and shorter length of hospital stay compared to open book laminectomy. However, there were two (2/24) patients in group A that had neurological deficits postoperatively and required a second exploratory operation. Dural tears and/or cauda equina entrapment were subsequently found in four patients in group B and all two patients of neurological deficits in group A during operation. No screw loosening, plate breakage, or other internal fixation failures were found at final follow-up. The results demonstrated that either of the two surgical approaches can achieve satisfactory results in treating thoracolumbar burst fractures in patients with greenstick lamina fractures. However, if there is any clinical or radiographic suspicion of a dural tear and/or cauda equina entrapment pre-operation, patients should receive an open book laminectomy to avoid a second exploratory operation. More research is still needed to optimize clinical decision-making regarding surgical approach.

Comparative Effectiveness and Economic Evaluations of Open Versus Minimally Invasive Posterior or Transforaminal Lumbar Interbody Fusion: A Systematic Review.

PubMed

Goldstein, Christina L; Phillips, Frank M; Rampersaud, Y Raja

2016-04-01

Systematic review of randomized and nonrandomized comparative studies. To summarize the literature examining comparative effectiveness and economic evaluation of minimally invasive versus open transforaminal/posterior lumbar interbody fusion (T/PLIF). Minimally invasive approaches to lumbar fusion have been proposed as an alternative to open surgery to decrease patient morbidity and improve clinical and patient-reported outcomes, with the possibility of secondary cost-savings. The comparative clinical and economic effectiveness of minimally invasive versus open T/PLIF remains largely undetermined. A systematic review of Medline, EMBASE, Web of Science, and Cochrane from database inception to September 2015 inclusive was performed. Reference lists were manually searched. Studies comparing MIS to open T/PLIF for degenerative lumbar conditions, including at least 10 patients in each arm and reporting at least one clinical, perioperative, radiographic, adverse event, or economic outcome, were included. Between database inception and October 2015, 45 studies meeting inclusion criteria were identified with 3472 subjects undergoing MIS fusion and 5925 having an open procedure. There were no significant differences in operative time between the two groups, whereas patients undergoing MIS fusion consistently demonstrated less blood loss (16.1-88.7%) and shorter hospital stays (15.0-64.0% shorter). There was no difference in variably reported VAS, ODI, SF-36, SF-12, or EQ-5D scores between the two techniques at intermediate to long-term follow-up (12-60 months). Complication rates and fusion rates were also equivalent between the two groups. Economic studies demonstrate cost-savings in favor of MIS fusion ranging from 2.5 to 49.3%. Limited quality comparative observational cohort and randomized controlled studies of MIS versus open T/PLIF consistently demonstrate improved perioperative outcomes including operative time, estimated blood loss, and length of stay with no significant difference in patient-reported outcomes or complication rates between the two groups at final follow-up. Increasing economic data suggest both direct and indirect cost-savings in favor of MIS fusion. N/A.

Postdural puncture headache is not an age-related symptom in children: a prospective, open-randomized, parallel group study comparing a22-gauge Quincke with a 22-gauge Whitacre needle.

PubMed

Kokki, H; Salonvaara, M; Herrgård, E; Onen, P

1999-01-01

Many reports have shown a low incidence of postdural puncture headache (PDPH) and other complaints in young children. The objective of this open-randomized, prospective, parallel group study was to compare the use of a cutting point spinal needle (22-G Quincke) with a pencil point spinal needle (22-G Whitacre) in children. We studied the puncture characteristics, success rate and incidence of postpuncture complaints in 57 children, aged 8 months to 15 years, following 98 lumbar punctures (LP). The patient/parents completed a diary at 3 and 7 days after LP. The response rate was 97%. The incidence of PDPH was similar, 15% in the Quincke group and 9% in the Whitacre group (P=0.42). The risk of developing a PDPH was not dependent on the age (r < 0.00, P=0.67). Eight of the 11 PDPHs developed in children younger than 10 years, the youngest being 23-months-old.

Science Teacher Candidates' Learning and Studying Strategies in the Context of Self-Regulation

ERIC Educational Resources Information Center

Yilmaz, Özkan

2017-01-01

This study investigated the students' individual study and learning strategies. Toward this purpose, open ended question form was administered to 40 university students who have enrolled department of mathematics and science education, faculty of education. Students were selected randomly in all level of class. Qualitative research method was used…

An Open Label, Randomized, Comparative, Parallel Group, Multicenter, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of "AHPL/AYTOP/0113" in Comparison with "Framycetin Sulphate Cream" in Acute Wounds.

PubMed

Nipanikar, Sanjay U; Gajare, Kamalakar V; Vaidya, Vidyadhar G; Kamthe, Amol B; Upasani, Sachin A; Kumbhar, Vidyadhar S

2017-01-01

The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds. It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream) and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream). All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier). All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. Group-A subjects took significantly less ( P < 0.05) i.e., (mean) 7.77 days than (mean) 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better ( P < 0.05) results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. Excellent overall efficacy and tolerability was observed in subjects of both the groups. No adverse event or adverse drug reaction was noted in any subject of both the groups. AHPL/AYTOP/0113 cream proved to be superior to Framycetin sulphate cream in healing of acute wounds.

Patient Expectancy as a Mediator of Placebo Effects in Antidepressant Clinical Trials.

PubMed

Rutherford, Bret R; Wall, Melanie M; Brown, Patrick J; Choo, Tse-Hwei; Wager, Tor D; Peterson, Bradley S; Chung, Sarah; Kirsch, Irving; Roose, Steven P

2017-02-01

Causes of placebo effects in antidepressant trials have been inferred from observational studies and meta-analyses, but their mechanisms have not been directly established. The goal of this study was to examine in a prospective, randomized controlled trial whether patient expectancy mediates placebo effects in antidepressant studies. Adult outpatients with major depressive disorder were randomly assigned to open or placebo-controlled citalopram treatment. Following measurement of pre- and postrandomization expectancy, participants were treated with citalopram or placebo for 8 weeks. Independent samples t tests determined whether patient expectancy differed between the open and placebo-controlled groups, and mixed-effects models assessed group effects on Hamilton Depression Rating Scale (HAM-D) scores over time while controlling for treatment assignment. Finally, mediation analyses tested whether between-group differences in patient expectancy mediated the group effect on HAM-D scores. Postrandomization expectancy scores were significantly higher in the open group (mean=12.1 [SD=2.1]) compared with the placebo-controlled group (mean=11.0 [SD=2.0]). Mixed-effects modeling revealed a significant week-by-group interaction, indicating that HAM-D scores for citalopram-treated participants declined at a faster rate in the open group compared with the placebo-controlled group. Patient expectations postrandomization partially mediated group effects on week 8 HAM-D. Patient expectancy is a significant mediator of placebo effects in antidepressant trials. Expectancy-related interventions should be investigated as a means of controlling placebo responses in antidepressant clinical trials and improving patient outcome in clinical treatment.

Teacher Perceptions of Principals' Leadership Qualities: A Mixed Methods Study

ERIC Educational Resources Information Center

Hauserman, Cal P.; Ivankova, Nataliya V.; Stick, Sheldon L.

2013-01-01

This mixed methods sequential explanatory study utilized the Multi-factor Leadership Questionnaire, responses to open-ended questions, and in-depth interviews to identify transformational leadership qualities that were present among principals in Alberta, Canada. The first quantitative phase consisted of a random sample of 135 schools (with…

Which Surgical Treatment for Open Tibial Shaft Fractures Results in the Fewest Reoperations? A Network Meta-analysis.

PubMed

Foote, Clary J; Guyatt, Gordon H; Vignesh, K Nithin; Mundi, Raman; Chaudhry, Harman; Heels-Ansdell, Diane; Thabane, Lehana; Tornetta, Paul; Bhandari, Mohit

2015-07-01

Open tibial shaft fractures are one of the most devastating orthopaedic injuries. Surgical treatment options include reamed or unreamed nailing, plating, Ender nails, Ilizarov fixation, and external fixation. Using a network meta-analysis allows comparison and facilitates pooling of a diverse population of randomized trials across these approaches in ways that a traditional meta-analysis does not. Our aim was to perform a network meta-analysis using evidence from randomized trials on the relative effect of alternative approaches on the risk of unplanned reoperation after open fractures of the tibial diaphysis. Our secondary study endpoints included malunion, deep infection, and superficial infection. A network meta-analysis allows for simultaneous consideration of the relative effectiveness of multiple treatment alternatives. To do this on the subject of surgical treatments for open tibial fractures, we began with systematic searches of databases (including EMBASE and MEDLINE) and performed hand searches of orthopaedic journals, bibliographies, abstracts from orthopaedic conferences, and orthopaedic textbooks, for all relevant material published between 1980 and 2013. Two authors independently screened abstracts and manuscripts and extracted the data, three evaluated the risk of bias in individual studies, and two applied Grading of Recommendation Assessment, Development and Evaluation (GRADE) criteria to bodies of evidence. We included all randomized and quasirandomized trials comparing two (or more) surgical treatment options for open tibial shaft fractures in predominantly (ie, > 80%) adult patients. We calculated pooled estimates for all direct comparisons and conducted a network meta-analysis combining direct and indirect evidence for all 15 comparisons between six stabilization strategies. Fourteen trials published between 1989 and November 2011 met our inclusion criteria; the trials comprised a total of 1279 patients surgically treated for open tibial shaft fractures. Moderate confidence evidence showed that unreamed nailing may reduce the likelihood of reoperation compared with external fixation (network odds ratio [OR], 0.38; 95% CI, 0.23-0.62; p < 0.05), although not necessarily compared with reamed nailing (direct OR, 0.74; 95% CI, 0.45-1.24; p = 0.25). Only low- or very low-quality evidence informed the primary outcome for other treatment comparisons, such as those involving internal plate fixation, Ilizarov external fixation, and Ender nailing. Method ranking based on reoperation data showed that unreamed nailing had the highest probability of being the best treatment, followed by reamed nailing, external fixation, and plate fixation. CIs around pooled estimates of malunion and infection risk were very wide, and therefore no conclusive results could be made based on these data. Current evidence suggests that intramedullary nailing may be superior to other fixation strategies for open tibial shaft fractures. Use of unreamed nails over reamed nails also may be advantageous in the setting of open fractures, but this remains to be confirmed. Unfortunately, these conclusions are based on trials that have had high risk of bias and poor precision. Larger and higher-quality head-to-head randomized controlled trials are required to confirm these conclusions and better inform clinical decision-making. Level I, therapeutic study.

A randomized trial of obeticholic acid monotherapy in patients with primary biliary cholangitis.

PubMed

Kowdley, Kris V; Luketic, Velimir; Chapman, Roger; Hirschfield, Gideon M; Poupon, Raoul; Schramm, Christoph; Vincent, Catherine; Rust, Christian; Parés, Albert; Mason, Andrew; Marschall, Hanns-Ulrich; Shapiro, David; Adorini, Luciano; Sciacca, Cathi; Beecher-Jones, Tessa; Böhm, Olaf; Pencek, Richard; Jones, David

2018-05-01

Obeticholic acid (OCA), a potent farnesoid X receptor agonist, was studied as monotherapy in an international, randomized, double-blind, placebo-controlled phase 2 study in patients with primary biliary cholangitis who were then followed for up to 6 years. The goals of the study were to assess the benefit of OCA in the absence of ursodeoxycholic acid, which is relevant for patients who are intolerant of ursodeoxycholic acid and at higher risk of disease progression. Patients were randomized and dosed with placebo (n = 23), OCA 10 mg (n = 20), or OCA 50 mg (n = 16) given as monotherapy once daily for 3 months (1 randomized patient withdrew prior to dosing). The primary endpoint was the percent change in alkaline phosphatase from baseline to the end of the double-blind phase of the study. Secondary and exploratory endpoints included change from baseline to month 3/early termination in markers of cholestasis, hepatocellular injury, and farnesoid X receptor activation. Efficacy and safety continue to be monitored through an ongoing 6-year open-label extension (N = 28). Alkaline phosphatase was reduced in both OCA groups (median% [Q1, Q3], OCA 10 mg -53.9% [-62.5, -29.3], OCA 50 mg -37.2% [-54.8, -24.6]) compared to placebo (-0.8% [-6.4, 8.7]; P < 0.0001) at the end of the study, with similar reductions observed through 6 years of open-label extension treatment. OCA improved many secondary and exploratory endpoints (including γ-glutamyl transpeptidase, alanine aminotransferase, conjugated bilirubin, and immunoglobulin M). Pruritus was the most common adverse event; 15% (OCA 10 mg) and 38% (OCA 50 mg) discontinued due to pruritus. OCA monotherapy significantly improved alkaline phosphatase and other biochemical markers predictive of improved long-term clinical outcomes. Pruritus increased dose-dependently with OCA treatment. Biochemical improvements were observed through 6 years of open-label extension treatment. (Hepatology 2018;67:1890-1902). © 2017 The Authors. Hepatology published by Wiley Periodicals, Inc. on behalf of American Association for the Study of Liver Diseases.

Efficacy of Temporomandibular Joint Arthrocentesis with Sodium Hyaluronate in the Management of Temporomandibular Joint Disorders: A Prospective Randomized Control Trial.

PubMed

Gorrela, Harsha; Prameela, J; Srinivas, G; Reddy, B Vijay Baskar; Sudhir, Mvs; Arakeri, Gururaj

2017-12-01

This study was designed to investigate the efficacy of the temporomandibular joint arthrocentesis with and without injection of sodium hyaluronate (SH) in the treatment of temporomandibular joint disorders. A total of sixty two TMJs in 34 males and 28 females aged 20-65 years comprised the study material. The patients' complaints were limited mouth opening, TMJ pain, and joint noises during function. Patients were randomly divided into 2 groups in which arthrocentesis plus intra-articular injection of sodium hyaluronate was performed in 1 group and only arthrocentesis was performed in the other group. Both groups contained patients with disc displacement with reduction and without reduction. Clinical evaluation of the patients was done before the procedure, immediately after the procedure, at 1 week and 1, 3 and 6 months postoperatively. Intensity of TMJ pain was assessed using visual analog scales. Maximal mouth opening and lateral jaw movements also were recorded at each follow-up visit. Both techniques increased maximal mouth opening, lateral movements, and function, while reducing TMJ pain and noise. Although patients benefitted from both techniques, arthrocentesis with injection of SH seemed to be superior to arthrocentesis alone.

Current Role of Minimally Invasive Radical Cholecystectomy for Gallbladder Cancer

PubMed Central

Manzoni, Alberto; Guerini, Francesca; Ramera, Marco; Aroldi, Francesca; Zaniboni, Alberto; Rosso, Edoardo

2016-01-01

Background. For Tis and T1a gallbladder cancer (GbC), laparoscopic cholecystectomy can provide similar survival outcomes compared to open cholecystectomy. However, for patients affected by resectable T1b or more advanced GbC, open approach radical cholecystectomy (RC), consisting in gallbladder liver bed resection or segment 4b-5 bisegmentectomy, with locoregional lymphadenectomy, is considered the gold standard while minimally invasive RC (MiRC) is skeptically considered. Aim. To analyze current literature on perioperative and oncologic outcomes of MiRC for patients affected by GbC. Methods. A Medline review of published articles until June 2016 concerning MiRC for GbC was performed. Results. Data relevant for this review were presented in 13 articles, including 152 patients undergoing an attempt of MiRC for GbC. No randomized clinical trial was found. The approach was laparoscopic in 147 patients and robotic in five. Conversion was required in 15 (10%) patients. Postoperative complications rate was 10% with no mortality. Long-term survival outcomes were reported by 11 studies, two of them showing similar oncologic results when comparing MiRC with matched open RC. Conclusions. Although randomized clinical trials are still lacking and only descriptive studies reporting on limited number of patients are available, current literature seems suggesting that when performed at highly specialized centers, MiRC for GbC is safe and feasible and has oncologic outcomes comparable to open RC. PMID:27885325

Current Role of Minimally Invasive Radical Cholecystectomy for Gallbladder Cancer.

PubMed

Zimmitti, Giuseppe; Manzoni, Alberto; Guerini, Francesca; Ramera, Marco; Bertocchi, Paola; Aroldi, Francesca; Zaniboni, Alberto; Rosso, Edoardo

2016-01-01

Background . For Tis and T1a gallbladder cancer (GbC), laparoscopic cholecystectomy can provide similar survival outcomes compared to open cholecystectomy. However, for patients affected by resectable T1b or more advanced GbC, open approach radical cholecystectomy (RC), consisting in gallbladder liver bed resection or segment 4b-5 bisegmentectomy, with locoregional lymphadenectomy, is considered the gold standard while minimally invasive RC (MiRC) is skeptically considered. Aim . To analyze current literature on perioperative and oncologic outcomes of MiRC for patients affected by GbC. Methods . A Medline review of published articles until June 2016 concerning MiRC for GbC was performed. Results . Data relevant for this review were presented in 13 articles, including 152 patients undergoing an attempt of MiRC for GbC. No randomized clinical trial was found. The approach was laparoscopic in 147 patients and robotic in five. Conversion was required in 15 (10%) patients. Postoperative complications rate was 10% with no mortality. Long-term survival outcomes were reported by 11 studies, two of them showing similar oncologic results when comparing MiRC with matched open RC. Conclusions . Although randomized clinical trials are still lacking and only descriptive studies reporting on limited number of patients are available, current literature seems suggesting that when performed at highly specialized centers, MiRC for GbC is safe and feasible and has oncologic outcomes comparable to open RC.

Ultrathin Silicon Sheet in the Management of Unilateral Post-traumatic Temporo-Mandibuar Joint Ankylosis in Children: A Good Alternative to Conventional Techniques.

PubMed

Aggarwal, Sushil Kumar; Ankur, Bhatnagar; Jain, R K

2015-09-01

We have described a new technique of using ultra-thin silicon sheet (0.2 mm) between two transected bony ends for temporo-mandibular joint (TMJ) ankylosis in children with advantages of short operative time, minimal foreign material insertion and faster recovery time post-operatively which makes our technique a good alternative to conventional techniques. Our study is a non-randomized prospective study conducted on 10 children aged between 4 and 15 years who presented to our tertiary care institute with severe trismus after traumatic injury and were willing to undergo this new technique. The main outcome measure taken into consideration was difference between pre-operative, intra-operative (on table) and post-operative mouth opening (minimum 2 years follow-up). The pre-operative mouth opening in our cases varied from 1 to 5 mm. The intra-operative mouth opening achieved ranged from 2.8 to 3.2 cm. The mouth opening was about more than 2.7 cm in all our cases at 2 years of follow-up. Our technique is a good alternative to conventional techniques used for TMJ ankylosis in children but few more randomized controlled trials are required to assess its effectiveness in comparison to conventional techniques and for universal adoption of this technique.

Case studies combined with or without concept maps improve critical thinking in hospital-based nurses: a randomized-controlled trial.

PubMed

Huang, Yu-Chuan; Chen, Hsing-Hsia; Yeh, Mei-Ling; Chung, Yu-Chu

2012-06-01

Critical thinking (CT) is essential to the exercise of professional judgment. As nurses face increasingly complex health-care situations, critical thinking can promote appropriate clinical decision-making and improve the quality of nursing care. This study aimed to evaluate the effects of a program of case studies, alone (CS) or combined with concept maps (CSCM), on improving CT in clinical nurses. The study was a randomized controlled trial. The experimental group participated in a 16-week CSCM program, whereas the control group participated in a CS program of equal duration. A randomized-controlled trial with a multistage randomization process was used to select and to assign participants, ultimately resulting in 67 nurses in each group. Data were collected before and after the program using the California Critical Thinking Skill Test (CCTST) and the California Critical Thinking Disposition Inventory (CCTDI). After the programs, there were significant differences between the two groups in the critical thinking skills of analysis, evaluation, inference, deduction, and induction. There was also an overall significant difference, and a significant difference in the specific disposition of open-mindedness. This study supports the application of case studies combined with concept maps as a hospital-based teaching strategy to promote development of critical thinking skills and encourage dispositions for nurses. The CSCM resulted in greater improvements in all critical thinking skills of as well as the overall and open-minded affective dispositions toward critical thinking, compared with the case studies alone. An obvious improvement in the CSCM participants was the analytic skill and disposition. Further longitudinal studies and data collection from multisite evaluations in a range of geographic locales are warranted. Copyright © 2012 Elsevier Ltd. All rights reserved.

Evaluation of Cyavanaprāśa on Health and Immunity related Parameters in Healthy Children: A Two Arm, Randomized, Open Labeled, Prospective, Multicenter, Clinical Study

PubMed Central

Gupta, Arun; Kumar, Sunil; Dole, Sanjeeva; Deshpande, Shailesh; Deshpande, Vaishali; Singh, Sudha; Sasibhushan, V.

2017-01-01

Context: Cyavanaprāśa (CP) is an Ayurvedic immune booster formulation that confers vigor and vitality while delaying the ageing process. Benefits of CP have been studied widely in adult population. Objectives: Current study assessed beneficial effects of CP on health and immunity related parameters in healthy children. Methods: This study was a 6 month long two armed, randomized, open labeled, prospective clinical study. School going healthy children between ages of 5-12 years were randomized to receive orally daily either CP (approx. 6 g) followed by a cup of milk (100 – 200 ml) or cup of milk only twice a day while continuing with their normal/routine diet. Results were analyzed based on number of episodes, severity, duration of illness (infections and allergies) and number of absent days due to illness during the study duration and changes in levels of energy, physical fitness, strength, stamina and quality of life in children which were recorded in subject diary by their parents/Legally Acceptable Representative (LAR). Results: 702 participants were randomized, out of which 627 completed the study (CP n = 313; Control n = 314). Results of immunity (episodes of infections or allergy related conditions) showed more than 2 times protection from immunity related illness in CP Group as compared to the control. CP also showed better percentage improvement in energy levels, physical fitness, strength, stamina and quality of life assessed through KIDSCREEN QOL-27 questionnaires in children. Conclusion: Regular consumption of CP for a period of six months could significantly improve immunity, energy levels, physical fitness, strength, stamina and quality of life in school going healthy children. Study Registration: Clinical Trail Registry of India vide CTRI/2015/02/005574, Dated 24 February 2015. PMID:28867858

Public evaluation of open space in Illinois: citizen support for natural area acquisition.

PubMed

Backlund, Erik A; Stewart, William P; McDonald, Cary; Miller, Craig

2004-11-01

Numerous studies have indicated a broad-based support for open space preservation and protection. Research also has characterized the public values and rationale that underlie the widespread support for open space. In recognition of the widespread public support for open space, various levels of government have implemented programs to provide public access to open space. There are many different types of open space, ranging from golf courses, ball parks, wildlife areas, and prairies, to name a few. This paper addresses questions related to the types of open space that should be prioritized by planners and natural resource managers. The results of this study are based on a stratified random sample of 5000 households in Illinois that were sent a questionnaire related to their support for various types of open space. Through a comparatively simple action grid analysis, the open space types that should be prioritized for public access include forest areas, stream corridors, wildlife habitat, and lakes/ponds. These were the open space types rated of the highest importance, yet were also the open space types rated the lowest in respondent satisfaction. This kind of analysis does not require the technical expertise of other options for land-use prioritizations (e.g., conjoint analysis, contingent valuation), yet provides important policy directives for planners. Although open space funds often allow for purchase of developed sites such as golf courses, ball parks, and community parks, this study indicates that undeveloped (or nature-based) open space lands are most needed in Illinois.

Modeling for Ultrasonic Health Monitoring of Foams with Embedded Sensors

NASA Technical Reports Server (NTRS)

Wang, L.; Rokhlin, S. I.; Rokhlin, Stanislav, I.

2005-01-01

In this report analytical and numerical methods are proposed to estimate the effective elastic properties of regular and random open-cell foams. The methods are based on the principle of minimum energy and on structural beam models. The analytical solutions are obtained using symbolic processing software. The microstructure of the random foam is simulated using Voronoi tessellation together with a rate-dependent random close-packing algorithm. The statistics of the geometrical properties of random foams corresponding to different packing fractions have been studied. The effects of the packing fraction on elastic properties of the foams have been investigated by decomposing the compliance into bending and axial compliance components. It is shown that the bending compliance increases and the axial compliance decreases when the packing fraction increases. Keywords: Foam; Elastic properties; Finite element; Randomness

[Alcohol withdrawal syndrome dynamics during treatment with nooclerin (deanoli aceglumas)].

PubMed

Agibalova, T V; Buzik, O Zh; Rychkova, O V; Smyshlyaev, A V; Rumbesht, V V

2018-01-01

To study the efficacy of nooclerin (deanoli aceglumas) in alcohol withdrawal syndrome assessed by clinical and biochemical characteristics. A multicenter, open, randomized, comparative study of nooclerin in the complex treatment of alcohol withdrawal syndrome included 90 patients. The patients were randomized into nooclerin group (n=55) and control group (n=35). Nooclerin reduced alcohol withdrawal symptoms more significantly throughout the whole study period. There were significant between-group differences on the Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) and the Multidimensional Fatigue Inventory (МFI-20). However, patients exhibited no excessive activity. No adverse side-effects were observed.

An open randomized controlled study comparing an online text-based scenario and a serious game by Belgian and Swiss pharmacy students.

PubMed

Berger, Jérôme; Bawab, Noura; De Mooij, Jeremy; Sutter Widmer, Denise; Szilas, Nicolas; De Vriese, Carine; Bugnon, Olivier

2018-03-01

To compare online learning tools, looped, branch serious game (SG) and linear text-based scenario (TBS), among a sample of Belgian and Swiss pharmacy students. Open randomized controlled study. The lesson was based on the case of a benign cough in a healthy child. A randomized sample of 117 students: only the Swiss students had attended a previous lecture on coughs. Participation rate, pre- and post-experience Likert scales and students' clinical knowledge were measured. Our primary hypothesis was demonstrated: students favored the SG even if navigation was rated as more complex, and students who performed the SG better understood the aim of pharmacist triage in case of cough. The influence of the SG appeared to be linked to the presence of a previous lecture in the curriculum. SG and TBS are effective to teach pharmacist triage. Higher SG complexity should be used to teach the aim of pharmacist triage in the case of a specific disease and could be an alternative to simulated patients. A simpler TBS does not require a previous lecture and a debriefing to be fully effective. Copyright © 2017 Elsevier Inc. All rights reserved.

Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients

PubMed Central

Tedesco-Silva, Helio; Peddi, V. Ram; Sánchez-Fructuoso, Ana; Marder, Brad A.; Russ, Graeme R.; Diekmann, Fritz; Flynn, Alison; Hahn, Carolyn M.; Li, Huihua; Tortorici, Michael A.; Schulman, Seth L.

2016-01-01

Background Calcineurin inhibitor–associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients. Methods This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus. The primary end point was percentage of patients with 5 mL/min per 1.73 m2 or greater improvement in estimated glomerular filtration rate from randomization to month 24. Results The on-therapy population included 195 patients (sirolimus, 86; tacrolimus, 109). No between-group difference was noted in percentage of patients with 5 mL/min per 1.73 m2 or greater estimated glomerular filtration rate improvement (sirolimus, 34%; tacrolimus, 42%; P = 0.239) at month 24. Sirolimus patients had higher rates of biopsy-confirmed acute rejection (8% vs 2%; P = 0.02), treatment discontinuation attributed to adverse events (21% vs 3%; P < 0.001), and lower rates of squamous cell carcinoma of the skin (0% vs 5%; P = 0.012). Conclusions Our findings suggest that renal function improvement at 24 months is similar for patients with early conversion to sirolimus after kidney transplantation versus those remaining on tacrolimus. PMID:27500260

Comparison of fertilization outcome between microdrop and open insemination methods in non-male factor IVF patients.

PubMed

Li, Yubin; Li, Tao; Mai, Qingyun; Long, Lingli; Ou, Jianping

2014-06-01

Both microdrop and open methods are commonly used for in vitro fertilization (IVF) protocols for embryo culture as well as oocyte insemination. However, few comparative studies evaluating the microdrop or open method of insemination on the fertilization outcome and subsequent embryo development have been performed. A randomized study was conducted to compare microdrop and open fertilization with respect to fertilization rate and embryo development among non-male factor patients undergoing in vitro fertilization and embryo transfer (IVF-ET). The results presented in this study demonstrate that the fertilization failure rate [total fertilization failure rate (TFF) plus low fertilization rate (<25% oocytes fertilized)] in the microdrop insemination group was higher than in the open insemination group (11.9% versus 3.3%, p < 0.001), while the good quality embryo rate and pregnancy rate did not differ significantly between the groups. As a highly complicated process involving many extrinsic and intrinsic factors, further studies are needed to confirm the effects of these insemination methods on the rate of fertilization failure.

Open lung ventilation improves functional residual capacity after extubation in cardiac surgery.

PubMed

Reis Miranda, Dinis; Struijs, Ard; Koetsier, Peter; van Thiel, Robert; Schepp, Ronald; Hop, Wim; Klein, Jan; Lachmann, Burkhard; Bogers, Ad J J C; Gommers, Diederik

2005-10-01

After cardiac surgery, functional residual capacity (FRC) after extubation is reduced significantly. We hypothesized that ventilation according to the open lung concept (OLC) attenuates FRC reduction after extubation. A prospective, single-center, randomized, controlled clinical study. Cardiothoracic operating room and intensive care unit of a university hospital. Sixty-nine patients scheduled for elective coronary artery bypass graft and/or valve surgery with cardiopulmonary bypass. Before surgery, patients were randomly assigned to three groups: (1) conventional ventilation (CV); (2) OLC, started after arrival in the intensive care unit (late open lung); and (3) OLC, started directly after intubation (early open lung). In both OLC groups, recruitment maneuvers were applied until Pao2/Fio2 was >375 Torr (50 kPa). No recruitment maneuvers were applied in the CV group. FRC was measured preoperatively and 1, 3, and 5 days after extubation. Peripheral hemoglobin saturation (Spo2) was measured daily till the third day after extubation while the patient was breathing room air. Hypoxemia was defined by an Spo2 value < or =90%. Averaged over the 5 postoperative days, FRC was significantly higher in the early open lung group and tended to be higher in the late open lung group, in comparison with the CV group (mean +/- sem: CV, 1.8 +/- 0.1; late open lung,1.9 +/- 0.1; and early open lung, 2.2 +/- 0.1l). In the CV group, 37% of the patients were hypoxic on the third day after extubation, compared with none of the patients in both OLC groups. After cardiac surgery, earlier application of OLC resulted in a significantly higher FRC and fewer episodes of hypoxemia than with CV after extubation.

The Effects of Orally Administered Beta-Glucan on Innate Immune Responses in Humans, a Randomized Open-Label Intervention Pilot-Study

PubMed Central

Leentjens, Jenneke; Quintin, Jessica; Gerretsen, Jelle; Kox, Matthijs; Pickkers, Peter; Netea, Mihai G.

2014-01-01

Rationale To prevent or combat infection, increasing the effectiveness of the immune response is highly desirable, especially in case of compromised immune system function. However, immunostimulatory therapies are scarce, expensive, and often have unwanted side-effects. β-glucans have been shown to exert immunostimulatory effects in vitro and in vivo in experimental animal models. Oral β-glucan is inexpensive and well-tolerated, and therefore may represent a promising immunostimulatory compound for human use. Methods We performed a randomized open-label intervention pilot-study in 15 healthy male volunteers. Subjects were randomized to either the β -glucan (n = 10) or the control group (n = 5). Subjects in the β-glucan group ingested β-glucan 1000 mg once daily for 7 days. Blood was sampled at various time-points to determine β-glucan serum levels, perform ex vivo stimulation of leukocytes, and analyze microbicidal activity. Results β-glucan was barely detectable in serum of volunteers at all time-points. Furthermore, neither cytokine production nor microbicidal activity of leukocytes were affected by orally administered β-glucan. Conclusion The present study does not support the use of oral β-glucan to enhance innate immune responses in humans. Trial Registration ClinicalTrials.gov NCT01727895 PMID:25268806

Evaluation of Cyavanaprāśa on Health and Immunity related Parameters in Healthy Children: A Two Arm, Randomized, Open Labeled, Prospective, Multicenter, Clinical Study.

PubMed

Gupta, Arun; Kumar, Sunil; Dole, Sanjeeva; Deshpande, Shailesh; Deshpande, Vaishali; Singh, Sudha; Sasibhushan, V

2017-01-01

Cyavanaprāśa (CP) is an Ayurvedic immune booster formulation that confers vigor and vitality while delaying the ageing process. Benefits of CP have been studied widely in adult population. Current study assessed beneficial effects of CP on health and immunity related parameters in healthy children. This study was a 6 month long two armed, randomized, open labeled, prospective clinical study. School going healthy children between ages of 5-12 years were randomized to receive orally daily either CP (approx. 6 g) followed by a cup of milk (100 - 200 ml) or cup of milk only twice a day while continuing with their normal/routine diet. Results were analyzed based on number of episodes, severity, duration of illness (infections and allergies) and number of absent days due to illness during the study duration and changes in levels of energy, physical fitness, strength, stamina and quality of life in children which were recorded in subject diary by their parents/Legally Acceptable Representative (LAR). 702 participants were randomized, out of which 627 completed the study (CP n = 313; Control n = 314). Results of immunity (episodes of infections or allergy related conditions) showed more than 2 times protection from immunity related illness in CP Group as compared to the control. CP also showed better percentage improvement in energy levels, physical fitness, strength, stamina and quality of life assessed through KIDSCREEN QOL-27 questionnaires in children. Regular consumption of CP for a period of six months could significantly improve immunity, energy levels, physical fitness, strength, stamina and quality of life in school going healthy children. Clinical Trail Registry of India vide CTRI/2015/02/005574, Dated 24 February 2015.

Robotic Versus Open Renal Transplantation in Obese Patients: Protocol for a Cost-Benefit Markov Model Analysis

PubMed Central

Puttarajappa, Chethan; Wijkstrom, Martin; Ganoza, Armando; Lopez, Roberto; Tevar, Amit

2018-01-01

Background Recent studies have reported a significant decrease in wound problems and hospital stay in obese patients undergoing renal transplantation by robotic-assisted minimally invasive techniques with no difference in graft function. Objective Due to the lack of cost-benefit studies on the use of robotic-assisted renal transplantation versus open surgical procedure, the primary aim of our study is to develop a Markov model to analyze the cost-benefit of robotic surgery versus open traditional surgery in obese patients in need of a renal transplant. Methods Electronic searches will be conducted to identify studies comparing open renal transplantation versus robotic-assisted renal transplantation. Costs associated with the two surgical techniques will incorporate the expenses of the resources used for the operations. A decision analysis model will be developed to simulate a randomized controlled trial comparing three interventional arms: (1) continuation of renal replacement therapy for patients who are considered non-suitable candidates for renal transplantation due to obesity, (2) transplant recipients undergoing open transplant surgery, and (3) transplant patients undergoing robotic-assisted renal transplantation. TreeAge Pro 2017 R1 TreeAge Software, Williamstown, MA, USA) will be used to create a Markov model and microsimulation will be used to compare costs and benefits for the two competing surgical interventions. Results The model will simulate a randomized controlled trial of adult obese patients affected by end-stage renal disease undergoing renal transplantation. The absorbing state of the model will be patients' death from any cause. By choosing death as the absorbing state, we will be able simulate the population of renal transplant recipients from the day of their randomization to transplant surgery or continuation on renal replacement therapy to their death and perform sensitivity analysis around patients' age at the time of randomization to determine if age is a critical variable for cost-benefit analysis or cost-effectiveness analysis comparing renal replacement therapy, robotic-assisted surgery or open renal transplant surgery. After running the model, one of the three competing strategies will result as the most cost-beneficial or cost-effective under common circumstances. To assess the robustness of the results of the model, a multivariable probabilistic sensitivity analysis will be performed by modifying the mean values and confidence intervals of key parameters with the main intent of assessing if the winning strategy is sensitive to rigorous and plausible variations of those values. Conclusions After running the model, one of the three competing strategies will result as the most cost-beneficial or cost-effective under common circumstances. To assess the robustness of the results of the model, a multivariable probabilistic sensitivity analysis will be performed by modifying the mean values and confidence intervals of key parameters with the main intent of assessing if the winning strategy is sensitive to rigorous and plausible variations of those values. PMID:29519780

Minimally Invasive versus Open Approach for Right-Sided Colectomy: A Study in 12,006 Patients from the Dutch Surgical Colorectal Audit.

PubMed

Bosker, Robbert J I; Van't Riet, Esther; de Noo, Mirre; Vermaas, Maarten; Karsten, Tom M; Pierie, Jean-Pierre

2018-02-07

There is ongoing debate whether laparoscopic right colectomy is superior to open surgery. The purpose of this study was to address this issue and arrive at a consensus using data from a national database. Patients who underwent elective open or laparoscopic right colectomy for colorectal cancer during the period 2009-2013 were identified from the Dutch Surgical Colorectal Audit. Complications that occurred within 30 days after surgery and 30-day mortality rates were calculated and compared between open and laparoscopic resection. In total, 12,006 patients underwent elective open or laparoscopic surgery for right-sided colorectal cancer. Of these, 6,683 (55.7%) underwent open resection and 5,323 (44.3%) underwent laparoscopic resection. Complications occurred within 30 days after surgery in the laparoscopic group in 26.1% of patients and in 32.1% of patients in the open group (p < 0.001). Thirty-day mortality was also significantly lower in the laparoscopic group (2.2 vs. 3.6% p < 0.001). In this non-randomized, descriptive study conducted in the Netherlands, open right colectomy seems to have a higher risk for complications and mortality as compared to laparoscopic right colectomy, even after correction for confounding factors. © 2018 S. Karger AG, Basel.

Ease of opening of blistered solid dosage forms in a senior citizens target group.

PubMed

Braun-Münker, Myriam; Ecker, Felix

2016-10-30

Blisters differing in design and handling are established as packaging material for solid dosage forms. The ease of opening of blisters influences application and patient's compliance. In this study the influence of visibility and movability of solid dosage forms in blister packaging on both, easy opening and patient's satisfaction, were investigated by target group testing according to ONR CEN/TS 15945. For each testing 20 participants in the age of 65-80 years were recruited randomly. They opened the blisters on realistic terms without any auxiliary devices. Video documentation of the hands' movements was recorded to analyze the opening procedure. To show the influence of visibility of the dosage form in the blister, capsules size 1 were packed in transparent and opaque blisters. A moderate influence of the visibility on both, the ease of opening and patient satisfaction, was observed. A second study dealt with the movability of solid dosage forms in blisters. Therefore, three different sizes of tablets with similar shapes were packed in identical cavities. Limited movability was found as major criterion on effectiveness and effectivity of opening as well as on satisfaction with the opening procedure. Copyright © 2015 Elsevier B.V. All rights reserved.

The effects of listening to preferred music on pain intensity after open heart surgery

PubMed Central

Jafari, Hedayat; Zeydi, Amir Emami; Khani, Soghra; Esmaeili, Ravanbakhsh; Soleimani, Aria

2012-01-01

Background: Pain is a common phenomenon after surgery. Cardiac surgeries are no exception and patients generally experience acute pain after these surgeries. Inadequate pain management after cardiac surgery predisposes patients to many complications. Therefore, the aim of this study was to determine the effects of listening to preferred music on pain intensity after open heart surgery. Materials and Methods: This study was a randomized clinical trial (RCT) conducted in open heart intensive care unit (ICU) of a university hospital in Sari, Iran. A total of 60 patients who were scheduled to undergo open heart surgery were randomly allocated in two groups. Patients in the intervention group (n = 30) listened to their preferred music by headphones for 30 minutes, whereas those in the control group (n = 30) did not listen to music. Using a Numerical Rating Scale (NRS), pain intensity was measured among the patients before the intervention, and immediately, 30 minutes and one hour after the intervention. Data was analyzed by Chi-square test, student's t-test and repeated measures analysis of variance (ANOVA). Findings: Mean pain intensity in the intervention group before, immediately after, 30 minutes and one hour after the intervention were 5.8, 3.1, 2.5 and 2.4, respectively. Corresponding numbers in the control group were 4.7, 4.7, 4.8 and 4.9, respectively. Repeated measures ANOVA showed music to significantly reduce pain intensity (p = 0.0001) Conclusions: Music can be effective as a non-pharmacological, inexpensive, non-invasive and side effect free method for pain management after open heart surgery. PMID:23493927

Comparison of didactic lectures and open-group discussions in surgical teaching.

PubMed

Sirikumpiboon, Siripong

2014-11-01

The teaching of medicine has varied and has continued to develop until today. Most courses rely on the lecture although it may bring less benefit to students. Another teaching technique, the open group discussion, may not be the most effective, but is widely accepted as a teaching development especially for its overall improvement of student skills. Basically, the teaching of surgery has more limitations than other subjects because patients with critical conditions are required. The present study was designed to compare the effectiveness of these two teaching methods, the lecture and the open group discussion, in the Department of Surgery, Rajavithi Hospital. Fifth year medical students enrolled from 2554-2555 BE (AD 2011-2012) were recruited in the study and randomly divided in groups by the Office of Administration, College of Medicine, Rangsit University. A colorectal surgeon taught the subject, common anorectal disease, throughout the study year. The drawing method was used to randomize the members grouped by teaching methods. The assessment comprised multiple choice questions (MCQ) and multiple essay questions (MEQ). Seventy-three students (39 females, 34 males) were recruited. Students' basic characteristic showed no association between groups of teaching methods. Higher mean MEQ scores were found in the open discussion group (55.83%) compared with those taught by lecture (31.23%), exhibiting significant difference (p<0.001). With respect to MCQ1 and MCQ4, students in the open discussion group had higher scores than those in the lecture group), was also with statistical significance (p = 0.02). Teaching medicine differs from other disciplines. To achieve the most effective teaching performance, teaching methods may be limited in some subjects. This study was a partial project for teaching in the Department of Surgery. It was shown that students in the open discussion group had better MCQ and MEQ scores than those in the lecture group. In developing student skills, giving open discussion provided greater interaction between instructors and students. Importantly, the instructor should manage and facilitate questioning techniques to more effectively transfer course content.

The efficacy of early treatment of seasonal allergic rhinitis with benifuuki green tea containing O-methylated catechin before pollen exposure: an open randomized study.

PubMed

Maeda-Yamamoto, Mari; Ema, Kaori; Monobe, Manami; Shibuichi, Ikuo; Shinoda, Yuki; Yamamoto, Tomohiro; Fujisawa, Takao

2009-09-01

We previously reported that 'benifuuki' green tea containing O-methylated catechin significantly relieved the symptoms of perennial or seasonal rhinitis compared with a placebo green tea that did not contain O-methylated catechin in randomized double-blind clinical trials. In this study we assessed the effects of 'benifuuki' green tea on clinical symptoms of seasonal allergic rhinitis. An open-label, single-dose, randomized, parallel-group study was performed on 38 subjects with Japanese cedar pollinosis. The subjects were randomly assigned to long-term (December 27, 2006-April 8, 2007, 1.5 months before pollen exposure) or short-term (February 15, 2007: after cedar pollen dispersal--April 8, 2007) drinking of a 'benifuuki' tea drink containing 34 mg O-methylated catechin per day. Each subject recorded their daily symptom scores in a diary. The primary efficacy variable was the mean weekly nasal symptom medication score during the study period. The nasal symptom medication score in the long-term intake group was significantly lower than that of the short-term intake group at the peak of pollen dispersal. The symptom scores for throat pain, nose-blowing, tears, and hindrance to activities of daily living were significantly better in the long-term group than the short-term group. In particular, the differences in the symptom scores for throat pain and nose-blowing between the 2 groups were marked. We conclude that drinking 'benifuuki' tea for 1.5 months prior to the cedar pollen season is effective in reducing symptom scores for Japanese cedar pollinosis.

Permeability of model porous medium formed by random discs

NASA Astrophysics Data System (ADS)

Gubaidullin, A. A.; Gubkin, A. S.; Igoshin, D. E.; Ignatev, P. A.

2018-03-01

Two-dimension model of the porous medium with skeleton of randomly located overlapping discs is proposed. The geometry and computational grid are built in open package Salome. Flow of Newtonian liquid in longitudinal and transverse directions is calculated and its flow rate is defined. The numerical solution of the Navier-Stokes equations for a given pressure drop at the boundaries of the area is realized in the open package OpenFOAM. Calculated value of flow rate is used for defining of permeability coefficient on the base of Darcy law. For evaluating of representativeness of computational domain the permeability coefficients in longitudinal and transverse directions are compered.

Executive function in adults with attention-deficit/hyperactivity disorder during treatment with atomoxetine in a randomized, placebo-controlled, withdrawal study.

PubMed

Adler, Lenard; Tanaka, Yoko; Williams, David; Trzepacz, Paula T; Goto, Taro; Allen, Albert J; Escobar, Rodrigo; Upadhyaya, Himanshu P

2014-08-01

We assessed the executive function in adults with attention-deficit/hyperactivity disorder (ADHD) during atomoxetine treatment in a randomized withdrawal trial. Responders (Conners' ADHD Rating Scale-Investigator Rated: Screening Version [adult prompts] ≥30% reduction from baseline and Clinical Global Impression Scale-ADHD Severity score ≤3) to open-label atomoxetine (40-100 mg/d, 12 weeks) entered a 37-week double-blind maintenance period. Patients who maintained response (double-blind atomoxetine for 12 weeks) were randomized 1:1 to atomoxetine (80-100 mg/d, n = 266) or placebo (n = 258) for 25 weeks (total duration, 1 year). Patients and investigators were blinded to response criteria and randomization timing. Change in executive function was assessed with the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report and Informant T scores from the randomization to the last-observation-carried-forward postrandomization week 25 (after week 17). Of the enrolled patients (n = 2017; mean age, 33.2 years; male, 58.7%), 524 responders were randomized. During open-label atomoxetine, subscales and individual items on both BRIEF-A questionnaires showed significant improvement (P < 0.001). After randomization, the following T scores improved significantly (P ≤ 0.05) with patients in the atomoxetine group versus those in the placebo group: global executive composite, behavioral regulation, and metacognition indices; plan/organize, working memory, inhibit, task monitor and shift (both BRIEF-A questionnaires), emotional control and organization of materials (BRIEF-A Informant), and initiate (BRIEF-A Self-Report). Atomoxetine significantly improved the executive function compared with placebo, which was maintained for 25 weeks or more; the executive function of patients in the placebo group worsened but did not return to baseline levels after randomization.

The glassy random laser: replica symmetry breaking in the intensity fluctuations of emission spectra

PubMed Central

Antenucci, Fabrizio; Crisanti, Andrea; Leuzzi, Luca

2015-01-01

The behavior of a newly introduced overlap parameter, measuring the correlation between intensity fluctuations of waves in random media, is analyzed in different physical regimes, with varying amount of disorder and non-linearity. This order parameter allows to identify the laser transition in random media and describes its possible glassy nature in terms of emission spectra data, the only data so far accessible in random laser measurements. The theoretical analysis is performed in terms of the complex spherical spin-glass model, a statistical mechanical model describing the onset and the behavior of random lasers in open cavities. Replica Symmetry Breaking theory allows to discern different kinds of randomness in the high pumping regime, including the most complex and intriguing glassy randomness. The outcome of the theoretical study is, eventually, compared to recent intensity fluctuation overlap measurements demonstrating the validity of the theory and providing a straightforward interpretation of qualitatively different spectral behaviors in different random lasers. PMID:26616194

[TAVI in 2018 : new indications and open questions].

PubMed

Fournier, Stephane; Roguelov, Christan; Monney, Pierre; Kirsch, Mathias; Eeckhout, Eric; Antiochos, Panagiotis; Lamsidri, Sabine; Muller, Olivier

2018-05-23

The last years, various large randomized studies have demonstrated the benefit of TAVI (transcatheter aortic valve implantation) over medical therapy or over conventional surgical treatment in inoperable or very high risk patients with symptomatic severe aortic stenosis. More recently, new data has also shown that among patients at intermediate risk, TAVI is at least as beneficial as surgical valve replacement. In this article, we will focus on the new recommendations of the European society of cardiology but also on issues that remain open.

Relapse Prevention in Pediatric Patients with ADHD Treated with Atomoxetine: A Randomized, Double-Blind, Placebo-Controlled Study

ERIC Educational Resources Information Center

Michelson, David; Buitelaar, Jan K.; Danckaerts, Marina; Gillberg, Christopher; Spencer, Thomas J.; Zuddas, Alessandro; Faries, Douglas E.; Zhang, Shuyu; Biederman, Joseph

2004-01-01

Objective: Attention-deficit/hyperactivity disorder (ADHD) is typically treated over extended periods; however, few placebo-controlled, long-term studies of efficacy have been reported. Method: In a global multicenter study, children and adolescents who responded to an initial 12-week, open-label period of treatment with atomoxetine, a…

Normothermic Versus Hypothermic Cardiopulmonary Bypass in Children Undergoing Open Heart Surgery (Thermic-2): Study Protocol for a Randomized Controlled Trial

PubMed Central

Baos, Sarah; Sheehan, Karen; Culliford, Lucy; Pike, Katie; Ellis, Lucy; Parry, Andrew J; Stoica, Serban; Ghorbel, Mohamed T; Caputo, Massimo

2015-01-01

Background During open heart surgery, patients are connected to a heart-lung bypass machine that pumps blood around the body (“perfusion”) while the heart is stopped. Typically the blood is cooled during this procedure (“hypothermia”) and warmed to normal body temperature once the operation has been completed. The main rationale for “whole body cooling” is to protect organs such as the brain, kidneys, lungs, and heart from injury during bypass by reducing the body’s metabolic rate and decreasing oxygen consumption. However, hypothermic perfusion also has disadvantages that can contribute toward an extended postoperative hospital stay. Research in adults and small randomized controlled trials in children suggest some benefits to keeping the blood at normal body temperature throughout surgery (“normothermia”). However, the two techniques have not been extensively compared in children. Objective The Thermic-2 study will test the hypothesis that the whole body inflammatory response to the nonphysiological bypass and its detrimental effects on different organ functions may be attenuated by maintaining the body at 35°C-37°C (normothermic) rather than 28°C (hypothermic) during pediatric complex open heart surgery. Methods This is a single-center, randomized controlled trial comparing the effectiveness and acceptability of normothermic versus hypothermic bypass in 141 children with congenital heart disease undergoing open heart surgery. Children having scheduled surgery to repair a heart defect not requiring deep hypothermic circulatory arrest represent the target study population. The co-primary clinical outcomes are duration of inotropic support, intubation time, and postoperative hospital stay. Secondary outcomes are in-hospital mortality and morbidity, blood loss and transfusion requirements, pre- and post-operative echocardiographic findings, routine blood gas and blood test results, renal function, cerebral function, regional oxygen saturation of blood in the cerebral cortex, assessment of genomic expression changes in cardiac tissue biopsies, and neuropsychological development. Results A total of 141 patients have been successfully randomized over 2 years and 10 months and are now being followed-up for 1 year. Results will be published in 2015. Conclusions We believe this to be the first large pragmatic study comparing clinical outcomes during normothermic versus hypothermic bypass in complex open heart surgery in children. It is expected that this work will provide important information to improve strategies of cardiopulmonary bypass perfusion and therefore decrease the inevitable organ damage that occurs during nonphysiological body perfusion. Trial Registration ISRCTN Registry: ISRCTN93129502, http://www.isrctn.com/ISRCTN93129502 (Archived by WebCitation at http://www.webcitation.org/6Yf5VSyyG). PMID:26007621

A long-term, phase 2, multicenter, randomized, open-label, comparative safety study of pomaglumetad methionil (LY2140023 monohydrate) versus atypical antipsychotic standard of care in patients with schizophrenia

PubMed Central

2013-01-01

Background We compared the time to discontinuation due to lack of tolerability over 24 weeks in patients suffering from schizophrenia treated with pomaglumetad methionil (LY2140023 monohydrate, the prodrug of metabotropic glutamate 2/3 receptor agonist, LY404039) or standard of care (SOC: olanzapine, risperidone, or aripiprazole). Methods Study HBBR was a multicenter, randomized, open-label study comparing the long-term safety and tolerability of LY2140023 with SOC for schizophrenia. Patients had moderate symptomatology with prominent negative symptoms and evidence of functional impairment. Those who met entry criteria were randomized to open-label treatment with either LY2140023 (target dose: 40 mg twice daily [BID]; n = 130) or SOC (n = 131). Results There was no statistically significant difference between LY2140023 and SOC for time to discontinuation due to lack of tolerability (primary objective; P = .184). The Kaplan-Meier estimates revealed comparable time to event profiles. Only 27% of LY2140023 and 45% of SOC patients completed the 24-week open-label, active treatment phase. Twenty-seven patients (20.8%) in the LY2140023 group and 15 patients (11.5%) in the SOC group discontinued due to lack of efficacy (P = .044). Twenty-three patients (17.7%) in the LY2140023 group and 19 patients (14.5%) in the SOC group discontinued due to adverse events (physician and subject decision combined, P = .505). The incidence of serious adverse events was comparable between groups. LY2140023-treated patients reported significantly more treatment-emergent adverse events of vomiting, agitation, and dyspepsia, while SOC-treated patients reported significantly more akathisia and weight gain. The incidence of treatment-emergent parkinsonism (P = .011) and akathisia (P = .029) was significantly greater in SOC group. Improvement in PANSS total score over the initial 6 to 8 weeks of treatment was similar between groups, but improvement was significantly greater in the SOC group at 24-week endpoint (P = .004). LY2140023 and SOC groups had comparable negative symptom improvement at 24-week endpoint (P = .444). Conclusion These data provide further evidence that the potential antipsychotic LY2140023 monohydrate, with a glutamatergic mechanism of action, may have a unique tolerability profile characterized by a low association with some adverse events such as extrapyramidal symptoms and weight gain that may characterize currently available dopaminergic antipsychotics. Trials registration A Long-term, Phase 2, Multicenter, Randomized, Open-label, Comparative Safety Study of LY2140023 Versus Atypical Antipsychotic Standard of Care in Patients with DSM-IV-TR Schizophrenia ClinicalTrials.gov identifier: NCT00845026. PMID:23694720

The Role of Advanced High School Coursework in Increasing STEM Career Interest

ERIC Educational Resources Information Center

Sadler, Philip M.; Sonnert, Gerhard; Hazari, Zahra; Tai, Robert

2014-01-01

Several avenues are open to students who wish to study advanced science or mathematics in high school, which include Advanced Placement courses and teacher-designed courses unaffiliated with organized programs. We employ a retrospective cohort study of 4,691 nationally representative college students at 34 randomly selected, colleges and…

Clinicobiochemical evaluation of turmeric with black pepper and nigella sativa in management of oral submucous fibrosis-a double-blind, randomized preliminary study.

PubMed

Pipalia, Pratik R; Annigeri, Rajeshwari G; Mehta, Ranjeeta

2016-12-01

To investigate the effectiveness of turmeric with black pepper and nigella sativa in oral submucous fibrosis (OSMF). Forty OSMF patients were randomly divided into two groups. The study was performed under a double-blind, randomized design. Group A received turmeric with black pepper and group B received nigella sativa for 3 months. Clinical evaluation was done every 15 days. Patients' serum superoxide dismutase (SOD) levels were assessed before and after treatment and also compared with healthy controls. The response to treatment was analyzed using analysis of variance, paired t test, and unpaired t test. After the treatment, groups A and B showed 3.85 ± 0.22 mm and 3.6 ± 0.07 mm improvement in mouth opening, respectively (P < .01); 87.90% and 78.91% reduction in burning sensation, respectively (P < .01); and +0.62 U/mL and +0.74 U/mL improvement in serum SOD levels, respectively (P < .05). The maximum mouth opening achieved was 8 mm in group A and 7 mm in group B. The mean pretreatment SOD level for controls and patients was 3.61 ± 0.24 U/mL in group A and 2.63 ± 0.18 U/mL in group B. Turmeric with black pepper and nigella sativa improved mouth opening, burning sensation, and SOD levels in the present OSMF study patients; however, further investigations are needed. Copyright © 2016 Elsevier Inc. All rights reserved.

Randomized, placebo-controlled trial of low molecular weight heparin in active ulcerative colitis.

PubMed

de Bièvre, M A; Vrij, A A; Schoon, E J; Dijkstra, G; de Jong, A E; Oberndorff-Klein Woolthuis, A H; Hemker, H C; Stockbrügger, R W

2007-06-01

In several open and 1 controlled trial, unfractionated heparin was effective in the treatment of active ulcerative colitis (UC). Low molecular weight heparin (LMWH) had a similar effect in several open studies. We studied the efficacy, safety, and tolerability of LMWH in mild to moderately active UC in a randomized, double-blind, placebo-controlled trial. In all, 29 patients with a mild or moderate recurrence of UC during salicylate treatment were randomized to receive either reviparin 3,436 IU (n = 15) subcutaneously twice daily or placebo (n = 14). The study period was 8 weeks. Treatment was discontinued if there was no improvement at 4 weeks or at any disease progression. Primary outcome measure was clinical improvement at 8 weeks measured by the Colitis Activity Index (CAI) and the Clinical Symptoms Grading (CSG, based on the CAI). Endoscopic and histologic grading and quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) were secondary outcome measures. Patients were closely monitored for adverse events. Twenty of 29 patients finished the 8-week treatment period (reviparin versus placebo: 11 versus 9; P = 0.70). There was no difference in CSG, CAI, endoscopic and histologic grading, or IBDQ. Treatment was well tolerated and no serious adverse events occurred. In this study, treatment with LMWH showed no significant clinical advantage compared to placebo in mild to moderately active UC.

Laparoscopic versus open repair for perforated peptic ulcer: A meta analysis of randomized controlled trials.

PubMed

Tan, Shanjun; Wu, Guohao; Zhuang, Qiulin; Xi, Qiulei; Meng, Qingyang; Jiang, Yi; Han, Yusong; Yu, Chao; Yu, Zhen; Li, Ning

2016-09-01

The role of laparoscopic surgery in the repair for peptic ulcer disease is unclear. The present study aimed to compare the safety and efficacy of laparoscopic versus open repair for peptic ulcer disease. Randomized controlled trials (RCTs) comparing laparoscopic versus open repair for peptic ulcer disease were identified from MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and references of identified articles and relevant reviews. Primary outcomes were postoperative complications, mortality, and reoperation. Secondary outcomes were operative time, postoperative pain, postoperative hospital stay, nasogastric tube duration, and time to resume diet. Statistical analysis was carried out by Review Manage software. Five RCTs investigating a total of 549 patients, of whom, 279 received laparoscopic repair and 270 received open repair, were included in the final analysis. There were no significant differences between these two procedures in some primary outcomes including overal postoperative complication rate, mortality, and reoperation rate. Subcategory analysis of postoperative complications showed that laparoscopic repair had also similar rates of repair site leakage, intra-abdominal abscess, postoperative ileus, pneumonia, and urinary tract infection as open surgery, except of the lower surgical site infection rate (P < 0.05). In addition, there were also no significant differences between these two procedures in some second outcomes including operative time, postoperative hospital stay, and time to resume diet, but laparoscopic repair had shorter nasogastric tube duration (P < 0.05) and less postoperative pain (P < 0.05) than open surgery. Laparoscopic surgery is comparable with open surgery in the setting of repair for perforated peptic ulcer. The obvious advantages of laparoscopic surgery are the lower surgical site infection rate, shorter nasogastric tube duration and less postoperative pain. However, more higher quality studies should be undertaken to further assess the safety and efficacy of laparoscopic repair for peptic ulcer disease. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of perimembranous ventricular septal defects in children: a protocol for a network meta-analysis.

PubMed

You, Tao; Yi, Kang; Ding, Zhao-Hong; Hou, Xiao-Dong; Liu, Xing-Guang; Wang, Xin-Kuan; Ge, Long; Tian, Jin-Hui

2017-06-21

Both transcatheter device closure and surgical repair are effective treatments with excellent midterm outcomes for perimembranous ventricular septal defects (pmVSDs) in children. The mini-invasive periventricular device occlusion technique has become prevalent in research and application, but evidence is limited for the assessment of transcatheter closure, mini-invasive closure and open-heart surgical repair. This study comprehensively compares the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of pmVSDs in children using Bayesian network meta-analysis. A systematic search will be performed using Chinese Biomedical Literature Database, China National Knowledge Infrastructure, PubMed, EMBASE.com and the Cochrane Central Register of Controlled Trials to include random controlled trials, prospective or retrospective cohort studies comparing the efficacy, safety and costs of transcatheter closure, mini-invasive closure and open-heart surgical repair. The risk of bias for the included prospective or retrospective cohort studies will be evaluated according to the risk of bias in non-randomised studies of interventions (ROBINS-I). For random controlled trials, we will use risk of bias tool from Cochrane Handbook version 5.1.0. A Bayesian network meta-analysis will be conducted using R-3.3.2 software. Ethical approval and patient consent are not required since this study is a network meta-analysis based on published trials. The results of this network meta-analysis will be submitted to a peer-reviewed journal for publication. CRD42016053352. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomized placebo controlled trial

PubMed Central

2012-01-01

Background N-acetyl cysteine (NAC) is a glutathione precursor that has been shown to have antidepressant efficacy in a placebo-controlled trial. The current study aimed to investigate the maintenance effects of NAC following eight weeks of open-label treatment for bipolar disorder. Method The efficacy of a double blind randomized placebo controlled trial of 2 g/day NAC as adjunct maintenance treatment for bipolar disorder was examined. Participants (n = 149) had a Montgomery Asberg Depression Rating Score of ≥12 at trial entry and, after eight weeks of open-label NAC treatment, were randomized to adjunctive NAC or placebo, in addition to treatment as usual. Participants (primarily outpatients) were recruited through public and private services and through newspaper advertisements. Time to intervention for a mood episode was the primary endpoint of the study, and changes in mood symptoms, functionality and quality of life measures were secondary outcomes. Results There was a substantial decrease in symptoms during the eight-week open-label NAC treatment phase. During the subsequent double-blind phase, there was minimal further change in outcome measures with scores remaining low. Consequently, from this low plateau, between-group differences did not emerge on recurrence, clinical functioning or quality of life measures. Conclusions There were no significant between-group differences in recurrence or symptomatic outcomes during the maintenance phase of the trial; however, these findings may be confounded by limitations. Trial Registration The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12607000074493). PMID:22891797

Effect of mouth cleaning with hinokitiol-containing gel on oral malodor: a randomized, open-label pilot study.

PubMed

Iha, Kosaku; Suzuki, Nao; Yoneda, Masahiro; Takeshita, Toru; Hirofuji, Takao

2013-10-01

The aim of the study was to evaluate the effect of mouth cleaning with hinokitiol-containing gel on oral malodor. An open-label, randomized, controlled trial was conducted to assess oral malodor and clinical parameters related to oral malodor before and after mouth cleaning with hinokitiol-containing gel (n = 9) or with gel not including hinokitiol (n = 9). Mouth cleaning included the teeth, gingiva, and tongue and was carried out 3 times per day for 4 weeks. Organoleptic test (OLT) scores (P = .021), levels of hydrogen sulfide (P = .008) and methyl mercaptan (P = .020), frequency of bleeding on probing, average probing pocket depth, and plaque index significantly improved in the group using hinokitiol. In contrast, only the OLT score (P = .031) significantly improved in the control group after the treatment regimen. Mouth cleaning with hinokitiol-containing gel may be effective for reduction of oral malodor. Copyright © 2013 Elsevier Inc. All rights reserved.

[Meta-analysis of laparoscopic and open repair of perforated peptic ulcer].

PubMed

Ding, Jie; Liao, Guo-qing; Zhang, Zhong-min; Pan, Yang; Li, Dong-miao; Wang, Run-hua; Xu, Kai-sheng; Yang, Xiao-fei; Yuan, Ping; Wang, Shao-yong

2011-10-01

To assess the safety and feasibility of laparoscopic and open repair of perforated peptic ulcer. Studies on comparison between laparoscopic repair(LR) and open repair(OR) of perforated peptic ulcer were collected. Data of operating time, blood loss, time to first flatus, postoperative hospital stay, postoperative complications and mortality between LR group and OR group were meta-analyzed using fixed effect model and random effect model. Nineteen studies including 1507 patients were selected for this study,including laparoscopic surgery(n=673) and open surgery(n=834). There were significant differences in blood loss, time to first flatus, postoperative hospital stay, wound infection rate and mortality between LR group and OR group. However, no significant differences existed in operative time, postoperative sepsis, pulmonary infection, abdominal abscess, and suture leakage between the two groups. Laparoscopic repair of perforated peptic ulcer is associated with improved outcomes in terms of less blood loss, quicker recovery, and lower rates of wound infection and mortality. Laparoscopic repair of perforated peptic ulcer is safe and feasible.

Randomized, Double-Blind, Placebo-Controlled Trial of Asenapine Maintenance Therapy in Adults With an Acute Manic or Mixed Episode Associated With Bipolar I Disorder.

PubMed

Szegedi, Armin; Durgam, Suresh; Mackle, Mary; Yu, Sung Yun; Wu, Xiao; Mathews, Maju; Landbloom, Ronald P

2018-01-01

The authors determined the efficacy and safety of asenapine in preventing recurrence of any mood episode in adults with bipolar I disorder. Adults with an acute manic or mixed episode per DSM-IV-TR criteria were enrolled in this randomized, placebo-controlled trial consisting of an initial 12- to 16-week open-label period and a 26-week double-blind randomized withdrawal period. The target asenapine dosage was 10 mg b.i.d. in the open-label period but could be titrated down to 5 mg b.i.d. After completing the open-label period, subjects meeting stabilization/stable-responder criteria were randomized to asenapine or placebo treatment in the double-blind period. The primary efficacy endpoint was time to recurrence of any mood event during the double-blind period. Kaplan-Meier estimation was performed, and 95% confidence intervals were determined. Safety was assessed throughout. A total of 549 subjects entered the open-label period, of whom 253 enrolled in the double-blind randomized withdrawal period (127 in the placebo group; 126 in the asenapine group). Time to recurrence of any mood episode was statistically significantly longer for asenapine- than placebo-treated subjects. In post hoc analyses, significant differences in favor of asenapine over placebo were seen in time to recurrence of manic and depressive episodes. The most common treatment-emergent adverse events were somnolence (10.0%), akathisia (7.7%), and sedation (7.7%) in the open-label period and mania (11.9% of the placebo group compared with 4.0% of the asenapine group) and bipolar I disorder (6.3% compared with 1.6%) in the double-blind period. Long-term treatment with asenapine was more effective than placebo in preventing recurrence of mood events in adults with bipolar I disorder and was generally well-tolerated.

Efficacy of surgery for rotator cuff tendinopathy: a systematic review.

PubMed

Toliopoulos, Panagiota; Desmeules, François; Boudreault, Jennifer; Roy, Jean-Sébastien; Frémont, Pierre; MacDermid, Joy C; Dionne, Clermont E

2014-01-01

The objective of this study is to review randomized controlled trials evaluating the efficacy of surgery for the treatment of rotator cuff (RC) tendinopathy. Studies up to August 2013 were located in the PubMed, Embase, CINAHL, and PEDro databases using relevant keywords. Studies were included if: (1) participants had rotator cuff tendinopathy, (2) the trials were conducted on an adult population (≥18 years old), (3) at least one of the interventions studied was a surgical procedure, (4) study design was a randomized controlled trial (RCT), and (5) the article was written in English or French. Characteristics of the included studies were extracted using a standardized form. Two independent raters reviewed the methodological quality of the studies using the Risk of Bias Assessment tool developed by the Cochrane Collaboration Group. Differences were resolved by consensus. Fifteen trials met our inclusion criteria. After consensus, the mean methodological quality for all studies was 58.9 ± 10.8 %. In three out of four RCTs of moderate or low methodological quality, no significant difference in treatment effectiveness was observed between open or arthroscopic acromioplasty compared to exercises in the treatment of RC tendinopathy. Based on two studies of low or moderate methodological quality, no difference in treatment effectiveness was observed between arthroscopic and open acromioplasty. Two other RCTs of low to moderate quality, however, found that arthroscopic acromioplasty yielded better results in the short-term for shoulder range of motion in flexion but that both procedures were comparable in the long-term. One additional study favored open acromioplasty over arthroscopic acromioplasty for the treatment of RC tendinopathy. Based on low- to moderate-quality evidence, acromioplasty, be it open or arthroscopic, is no more effective than exercises for the treatment of RC tendinopathy. Low-grade evidence also suggests that arthroscopic acromioplasty may yield better results in the short-term for shoulder range of motion in flexion compared to open acromioplasty, but long-term results are comparable between the two types of surgery. More high-quality RCTs are required in order to provide comprehensive treatment guidelines to healthcare providers.

A randomized, placebo-controlled trial of controlled release melatonin treatment of delayed sleep phase syndrome and impaired sleep maintenance in children with neurodevelopmental disabilities.

PubMed

Wasdell, Michael B; Jan, James E; Bomben, Melissa M; Freeman, Roger D; Rietveld, Wop J; Tai, Joseph; Hamilton, Donald; Weiss, Margaret D

2008-01-01

The purpose of this study was to determine the efficacy of controlled-release (CR) melatonin in the treatment of delayed sleep phase syndrome and impaired sleep maintenance of children with neurodevelopmental disabilities including autistic spectrum disorders. A randomized double-blind, placebo-controlled crossover trial of CR melatonin (5 mg) followed by a 3-month open-label study was conducted during which the dose was gradually increased until the therapy showed optimal beneficial effects. Sleep characteristics were measured by caregiver who completed somnologs and wrist actigraphs. Clinician rating of severity of the sleep disorder and improvement from baseline, along with caregiver ratings of global functioning and family stress were also obtained. Fifty-one children (age range 2-18 years) who did not respond to sleep hygiene intervention were enrolled. Fifty patients completed the crossover trial and 47 completed the open-label phase. Recordings of total night-time sleep and sleep latency showed significant improvement of approximately 30 min. Similarly, significant improvement was observed in clinician and parent ratings. There was additional improvement in the open-label somnolog measures of sleep efficiency and the longest sleep episode in the open-label phase. Overall, the therapy improved the sleep of 47 children and was effective in reducing family stress. Children with neurodevelopmental disabilities, who had treatment resistant chronic delayed sleep phase syndrome and impaired sleep maintenance, showed improvement in melatonin therapy.

Photoionization cross sections for atomic chlorine using an open-shell random phase approximation

NASA Technical Reports Server (NTRS)

Starace, A. F.; Armstrong, L., Jr.

1975-01-01

The use of the Random Phase Approximation with Exchange (RPAE) for calculating partial and total photoionization cross sections and photoelectron angular distributions for open shell atoms is examined for atomic chlorine. Whereas the RPAE corrections in argon (Z=18) are large, it is found that those in chlorine (Z=17) are much smaller due to geometric factors. Hartree-Fock calculations with and without core relaxation are also presented. Sizable deviations from the close coupling results of Conneely are also found.

Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings.

PubMed

Weinreb, Robert N; Liebmann, Jeffrey M; Martin, Keith R; Kaufman, Paul L; Vittitow, Jason L

2018-01-01

To compare the diurnal intraocular pressure (IOP)-lowering effect of latanoprostene bunod (LBN) 0.024% with timolol maleate 0.5% in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Pooled analysis of two phase 3, randomized, multicenter, double-masked, parallel-group, noninferiority trials (APOLLO and LUNAR), each with open-label safety extension phases. Adults with OAG or OHT were randomized 2:1 to double-masked treatment with LBN once daily (qd) or timolol twice daily (bid) for 3 months followed by open-label LBN treatment for 3 (LUNAR) or 9 (APOLLO) months. IOP was measured at 8 AM, 12 PM, and 4 PM at week 2, week 6, and months 3, 6, 9, and 12. Of the 840 subjects randomized, 774 (LBN, n=523; timolol crossover to LBN, n=251) completed the efficacy phase, and 738 completed the safety extension phase. Mean IOP was significantly lower with LBN versus timolol at all 9 evaluation timepoints during the efficacy phase (P<0.001). A significantly greater proportion of LBN-treated subjects attained a mean IOP ≤18 mm Hg and IOP reduction ≥25% from baseline versus timolol-treated subjects (P<0.001). The IOP reduction with LBN was sustained through the safety phase; subjects crossed over from timolol to LBN experienced additional significant IOP lowering (P≤0.009). Both treatments were well tolerated, and there were no safety concerns with long-term LBN treatment. In this pooled analysis of subjects with OAG and OHT, LBN 0.024% qd provided greater IOP-lowering compared with timolol 0.5% bid and maintained lowered IOP through 12 months. LBN demonstrated a safety profile comparable to that of prostaglandin analogs.

Placebo Effects and the Common Cold: A Randomized Controlled Trial

PubMed Central

Barrett, Bruce; Brown, Roger; Rakel, Dave; Rabago, David; Marchand, Lucille; Scheder, Jo; Mundt, Marlon; Thomas, Gay; Barlow, Shari

2011-01-01

PURPOSE We wanted to determine whether the severity and duration of illness caused by the common cold are influenced by randomized assignment to open-label pills, compared with conventional double-blind allocation to active and placebo pills, compared with no pills at all. METHODS We undertook a randomized controlled trial among a population with new-onset common cold. Study participants were allocated to 4 parallel groups: (1) those receiving no pills, (2) those blinded to placebo, (3) those blinded to echinacea, and (4) those given open-label echinacea. Primary outcomes were illness duration and area-under-the-curve global severity. Secondary outcomes included neutrophil count and interleukin 8 levels from nasal wash at intake and 2 days later. RESULTS Of 719 randomized study participants, 2 were lost and 4 exited early. Participants were 64% female, 88% white, and aged 12 to 80 years. Mean illness duration for each group was 7.03 days for those in the no-pill group, 6.87 days for those blinded to placebo, 6.34 days for those blinded to echinacea, and 6.76 days for those in the open-label echinacea group. Mean global severity scores for the 4 groups were no pills, 286; blinded to placebo, 264; blinded to echinacea, 236; and open-label echinacea, 258. Between-group differences were not statistically significant. Comparing the no-pill with blinded to placebo groups, differences (95% confidence interval [CI]) were −0.16 days (95% CI, −0.90 to 0.58 days) for illness duration and −22 severity points (95% CI, −70 to 26 points) for global severity. Comparing the group blinded to echinacea with the open-label echinacea group, differences were 0.42 days (95% CI, −0.28 to 1.12 days) and 22 severity points (95% CI, −19 to 63 points). Median change in interleukin 8 concentration and neutrophil cell count, respectively by group, were 30 pg/mL and 1 cell for the no-pill group, 39 pg/mL and 1 cell for the group binded to placebo, 58 pg/mL and 2 cells for the group blinded to echinacea, and 70 pg/mL and 1 cell for the group with open-label echinacea, also not statistically significant. Among the 120 participants who at intake rated echinacea’s effectiveness as greater than 50 on a 100-point scale for which 100 is extremely effective, illness duration was 2.58 days shorter (95% CI, −4.47 to −0.68 days) in those blinded to placebo rather than no pill, and mean global severity score was 26% lower but not significantly different (−97.0, 95% CI, −249.8 to 55.8 points). In this subgroup, neither duration nor severity differed significantly between the group blinded to echinacea and the open-label echinacea group. CONCLUSIONS Participants randomized to the no-pill group tended to have longer and more severe illnesses than those who received pills. For the subgroup who believed in echinacea and received pills, illnesses were substantively shorter and less severe, regardless of whether the pills contained echinacea. These findings support the general idea that beliefs and feelings about treatments may be important and perhaps should be taken into consideration when making medical decisions. PMID:21747102

Deterministic Walks with Choice

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beeler, Katy E.; Berenhaut, Kenneth S.; Cooper, Joshua N.

2014-01-10

This paper studies deterministic movement over toroidal grids, integrating local information, bounded memory and choice at individual nodes. The research is motivated by recent work on deterministic random walks, and applications in multi-agent systems. Several results regarding passing tokens through toroidal grids are discussed, as well as some open questions.

Early botulinum toxin treatment for spastic pes equinovarus--a randomized double-blind placebo-controlled study.

PubMed

Fietzek, U M; Kossmehl, P; Schelosky, L; Ebersbach, G; Wissel, J

2014-08-01

Spastic pes equinovarus is a frequent pathological posture of the lower extremity. Botulinum toxin (BoNT/A) has been successfully applied to treat lower limb spasticity. However, the best time to initiate treatment remains unclear. A beneficial effect of an early treatment has been suggested in previous studies. A single-centre double-blind randomized placebo-controlled trial was performed to investigate the efficacy of BoNT/A to reduce muscle hypertonicity at the ankle. Fifty-two patients with unilateral or bilateral spastic pes equinovarus with a modified Ashworth score (mAS) of at least 1+ after stroke, traumatic brain injury or hypoxic encephalopathy were allocated to receive either BoNT/A or placebo treatment. A second, open injection was optional at week 12. Patients received unilateral or bilateral injections with 230 or 460 U onabotulinumtoxinA, respectively. The course of the mAS was explored during the open study phase. Patients who had received BoNT/A treatment had lower mAS compared with placebo at week 12 (P < 0.01). During the open label phase, patients from the placebo group showed further deterioration of muscle tone despite starting from a similar baseline and receiving BoNT treatment. Spastic feet that had received BoNT/A in the first cycle had comparatively lower mAS scores over all follow-up data and at week 24 (P < 0.01). The study demonstrates a reduction of muscular hypertonicity in spastic pes equines with BoNT/A treatment given during the first 3 months after the lesion. Exploratory analyses of the course of muscular hypertonicity during the open phase favour earlier to later treatment. © 2014 The Author(s) European Journal of Neurology © 2014 EAN.

Transanal hemorrhoidal dearterialization with mucopexy versus open hemorrhoidectomy in the treatment of hemorrhoids: a meta-analysis of randomized control trials.

PubMed

Xu, L; Chen, H; Lin, G; Ge, Q; Qi, H; He, X

2016-12-01

The aim of this study was to analyse the outcomes of transanal hemorrhoidal dearterialization with mucopexy (THDm) versus open hemorrhoidectomy (OH) in the management of hemorrhoids. Randomized controlled trials in English were found by searching PubMed, Web of science, EMBASE, and the Cochrane Library database. Trials that compared THDm with OH were identified. Data were extracted independently for each study, and a meta-analysis was performed using fixed and random effects models. Four trials, including 316 patients, met the inclusion criteria. No statistically significant differences were noted in either total complications or postoperative bleeding, incontinence, recurrent prolapse, and urinary retention rate. Operative time was significantly longer for THDm with Doppler guidance than for THDm without Doppler guidance. Patients returned to normal activities faster after THDm than after OH. No statistically significant differences between THDm and OH were noted with regard to recurrence and reoperation rates. Our meta-analysis shows that THDm and OH are equally effective and can be attempted for the management of hemorrhoids. However, for THDm with Doppler guidance, more instruments and a longer operative time are required. Future large-scale, high-quality, multicenter trials with long-term outcomes are needed to prove these results and determine whether Doppler guidance in THD is truly necessary or not.

Low-pressure capnoperitoneum reduces stress responses during pediatric laparoscopic high ligation of indirect inguinal hernia sac: A randomized controlled study.

PubMed

Niu, Xiaoguang; Song, Xubin; Su, Aiping; Zhao, Shanshan; Li, Qinghao

2017-04-01

We aimed to evaluate the effect of different capnoperitoneum pressures on stress responses in pediatric laparoscopic inguinal hernia repair. In this prospective randomized controlled study, 68 children with indirect inguinal hernia who underwent high ligation of hernia sac were randomly divided into 3 groups: high-pressure group (12 mm Hg, HP group, n = 26); low-pressure group (8 mm Hg, LP group, n = 20); open operation group (OP group, n = 22). Heart rate (HR), blood pressure, and end-tidal CO2 (PetCO2) were recorded, as well as the levels of adrenocorticotropic hormone (ACTH) and cortisol (COR) were measured by ELISAs before operation, during operation, and after operation, respectively. After establishing capnoperitoneum, HR, blood pressure, and PetCO2 were significantly increased in the HP group compared with the OP and LP groups (P < 0.05). Comparing the intraoperatively measured ACTH and COR concentrations of the HP group to the LP group, we noted higher values in the first (P < 0.05). There was no significant difference in the postoperative concentrations of ACTH and COR among the HP, LP, and OP groups. Laparoscopic surgery under LP capnoperitoneum or open operation may reduce stress responses and are superior to HP capnoperitoneum.

An Open-Label Randomized Multicenter Study Assessing the Noninferiority of a Caffeine-Based Topical Liquid 0.2% versus Minoxidil 5% Solution in Male Androgenetic Alopecia.

PubMed

Dhurat, Rachita; Chitallia, Jill; May, Theodor W; Jayaraaman, Ammani M; Madhukara, Jithendriya; Anandan, Subbu; Vaidya, Pradyumna; Klenk, Adolf

2017-01-01

Androgenetic alopecia is a condition with a high prevalence worldwide and affects both males and females. Currently, only 2 approved treatments exist: finasteride (males only) and minoxidil 2 or 5% solution (males and females). We conducted a randomized, open-label, multicenter noninferiority study to determine whether a caffeine-based 0.2% topical liquid would be no less effective than minoxidil 5% solution in males (n = 210) with androgenetic alopecia. The primary end point was the percentage change in the proportion of anagen hairs from baseline to 6 months using a frontal and occipital trichogram. At 6 months, the group of the 5% minoxidil solution showed a mean improvement in anagen ratio of the trichogram of 11.68%, and the group of the 0.2% caffeine solution had an anagen improvement of 10.59%. The difference of mean values between both groups was 1.09%. The statistical analysis was performed and reported in accordance with the CONSORT Guidelines 2010 for reporting of noninferiority and equivalence randomized trials. A caffeine-based topical liquid should be considered as not inferior to minoxidil 5% solution in men with androgenetic alopecia. © 2017 The Author(s) Published by S. Karger AG, Basel.

Robotic-assisted versus open radical cystectomy in bladder cancer: A meta-analysis of four randomized controlled trails.

PubMed

Tang, Jin-Qiu; Zhao, Zhihong; Liang, Yiwen; Liao, Guixiang

2018-02-01

Robot-assisted radical cystectomy (RARC) is increasing annually for treatment of bladder cancer. The objective of this meta-analysis was to compare the safety and efficacy of RARC and open radical cystectomy (ORC) for bladder cancer. Our meta-analysis searches were conducted using PubMed, Web of Science, and Cochrane Library databases to identify randomized controlled trials (RCT) assessing the two techniques. Four RCT studies were identified, including 239 cases. Our studies indicated that RARC was associated with longer operative time (WMD: 69.69, 95% CI:17.25 to122.12; P= 0.009), lower estimated blood loss (WMD: -299.83, 95% CI:-414.66to -184.99; P<0.00001). The two groups had no significant difference in overall perioperative complications, length of hospital stay, lymph node yield and positive surgical margins. RARC is mini-invasive alternative to ORC for bladder cancer. The advantage of RARC was reduced estimated blood loss. More studies are needed to compare the two techniques. Copyright © 2017 John Wiley & Sons, Ltd.

A prospective randomized study comparing laparoscopic transabdominal preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias.

PubMed

Ielpo, Benedetto; Duran, Hipolito; Diaz, Eduardo; Fabra, Isabel; Caruso, Riccardo; Malavé, Luis; Ferri, Valentina; Lazzaro, Sara; Kalivaci, Denis; Quijano, Yolanda; Vicente, Emilio

2017-07-19

In literature, only a few studies have prospectively compared the results of laparoscopic with open inguinal hernia repair yet none have compared bilateral inguinal hernia repair. The aim of this study is to compare the open Lichtenstein repair (OLR) with laparoscopic trans-abdominal preperitoneal (TAPP) repair in patients undergoing surgery for bilateral inguinal hernia. Patients were prospectively randomized between March 2013 and March 2015. Outcome parameters included hospital stay, operation time, postoperative complications, immediate postoperative pain and chronic pain, recurrence and quality of life. Sixty-one patients underwent TAPP repair and 73 underwent OLR. TAPP procedure had less early post-operative pain up to 7 days from surgery (p = 0.003), a shorter length of hospital stay (p = 0.001), less postoperative complications (p = 0.012) and less chronic pain (0.04) when compared with the OLR approach. TAPP procedure for bilateral inguinal hernia effectively reduces early postoperative pain, hospital stay and postoperative complications. Copyright © 2017 Elsevier Inc. All rights reserved.

Robot-assisted hysterectomy for endometrial and cervical cancers: a systematic review.

PubMed

Nevis, Immaculate F; Vali, Bahareh; Higgins, Caroline; Dhalla, Irfan; Urbach, David; Bernardini, Marcus Q

2017-03-01

Total and radical hysterectomies are the most common treatment strategies for early-stage endometrial and cervical cancers, respectively. Surgical modalities include open surgery, laparoscopy, and more recently, minimally invasive robot-assisted surgery. We searched several electronic databases for randomized controlled trials and observational studies with a comparison group, published between 2009 and 2014. Our outcomes of interest included both perioperative and morbidity outcomes. We included 35 observational studies in this review. We did not find any randomized controlled trials. The quality of evidence for all reported outcomes was very low. For women with endometrial cancer, we found that there was a reduction in estimated blood loss between the robot-assisted surgery compared to both laparoscopy and open surgery. There was a reduction in length of hospital stay between robot-assisted surgery and open surgery but not laparoscopy. There was no difference in total lymph node removal between the three modalities. There was no difference in the rate of overall complications between the robot-assisted technique and laparoscopy. For women with cervical cancer, there were no differences in estimated blood loss or removal of lymph nodes between robot-assisted and laparoscopic procedure. Compared to laparotomy, robot-assisted hysterectomy for cervical cancer showed an overall reduction in estimated blood loss. Although robot-assisted hysterectomy is clinically effective for the treatment of both endometrial and cervical cancers, methodologically rigorous studies are lacking to draw definitive conclusions.

Using instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders

NASA Astrophysics Data System (ADS)

Chaibub Neto, Elias

2016-11-01

Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparing control and active treatments in the presence of confounders. The key idea is to use randomization to separately manipulate treatment assignment and psychological encouragement conversations/interactions that increase the participants’ desire for improved symptoms. The proposed approach is able to improve the estimation of treatment effects in blinded studies and, most importantly, opens the doors to account for placebo effects in unblinded trials.

Inguinal and subinguinal micro-varicocelectomy, the optimal surgical management of varicocele: a meta-analysis

PubMed Central

Wang, Jun; Xia, Shu-Jie; Liu, Zhi-Hong; Tao, Le; Ge, Ji-Fu; Xu, Chen-Min; Qiu, Jian-Xin

2015-01-01

Conventional meta-analyses have shown inconsistent results for the efficacy of various treatments of varicoceles. Therefore, we performed a multiple-treatment meta-analysis to assess the effectiveness and safety of 10 methods of varicocelectomy and embolization/sclerotherapy. We systematically reviewed 35 randomized controlled trials and observational studies, from 1966 to August 5, 2013, which compared any of the following treatments for varococeles: laparoscopic, retroperitoneal, open inguinal and subinguinal varicocelectomy, microsurgical subinguinal and inguinal varicocelectomy, percutaneous venous embolization, Tauber antegrade sclerotherapy, retrograde sclerotherapy and expectant therapy (no treatment). Inguinal and subinguinal microsurgery, open inguinal, laparoscopic varicocelectomy showed a significant advantage over expectant therapy in terms of pregnancy rates (odds ratio (OR): 3.48, 2.68, 2.92 and 2.90, respectively). Compared with retroperitoneal open surgery, inguinal microsurgery showed an improvement of sperm density (mean difference (MD): 10.60, 95% confidence interval (CI): 1.92–19.60) and sperm motility (MD: 9.09, 95% CI: 4.88–13.30). Subinguinal and inguinal microsurgery outperformed retroperitoneal open surgery in terms of recurrence (OR: 0.05, 0.06 respectively). Tauber antegrade sclerotherapy and subinguinal microsurgery were associated with the lowest risk of hydrocele formation. The odds of overall complication, compared with retroperitoneal open varicocelectomy, were lowest for inguinal microsurgery (OR = 0.07, 95% CI: 0.02–0.19), followed by subinguinal microsurgery (OR = 0.09, 95% CI: 0.02–0.19). Inguinal and subinguinal micro-varicocelectomy had the highest pregnancy rates, significant increases in sperm parameters, with low odds of complication. These results warrant additional properly conducted randomized controlled clinical studies with larger sample sizes. PMID:25248652

An evidence-based review of pregabalin for the treatment of fibromyalgia.

PubMed

Arnold, Lesley M; Choy, Ernest; Clauw, Daniel J; Oka, Hiroshi; Whalen, Ed; Semel, David; Pauer, Lynne; Knapp, Lloyd

2018-04-16

Pregabalin, an α2-δ agonist, is approved for the treatment of fibromyalgia (FM) in the United States, Japan, and 37 other countries. The purpose of this article was to provide an in-depth, evidence-based summary of pregabalin for FM as demonstrated in randomized, placebo-controlled clinical studies, including open-label extensions, meta-analyses, combination studies and post-hoc analyses of clinical study data. PubMed was searched using the term "pregabalin AND fibromyalgia" and the Cochrane Library with the term "pregabalin". Both searches were conducted on 2 March 2017 with no other date limits set. Eleven randomized, double-blind, placebo-controlled clinical studies were identified including parallel group, two-way crossover and randomized withdrawal designs. One was a neuroimaging study. Five open-label extensions were also identified. Evidence of efficacy was demonstrated across the studies identified with significant and clinically relevant improvements in pain, sleep quality and patient status. The safety and tolerability profile of pregabalin is consistent across all the studies identified, including in adolescents, with dizziness and somnolence the most common adverse events reported. These efficacy and safety data are supported by meta-analyses (13 studies). Pregabalin in combination with other pharmacotherapies (7 studies) is also efficacious. Post-hoc analyses have demonstrated the onset of pregabalin efficacy as early as 1-2 days after starting treatment, examined the effect of pregabalin on other aspects of sleep beyond quality, and shown it is effective irrespective of the presence of a wide variety of patient demographic and clinical characteristics. Pregabalin is a treatment option for FM; its clinical utility has been comprehensively demonstrated.

Multivariate normal maximum likelihood with both ordinal and continuous variables, and data missing at random.

PubMed

Pritikin, Joshua N; Brick, Timothy R; Neale, Michael C

2018-04-01

A novel method for the maximum likelihood estimation of structural equation models (SEM) with both ordinal and continuous indicators is introduced using a flexible multivariate probit model for the ordinal indicators. A full information approach ensures unbiased estimates for data missing at random. Exceeding the capability of prior methods, up to 13 ordinal variables can be included before integration time increases beyond 1 s per row. The method relies on the axiom of conditional probability to split apart the distribution of continuous and ordinal variables. Due to the symmetry of the axiom, two similar methods are available. A simulation study provides evidence that the two similar approaches offer equal accuracy. A further simulation is used to develop a heuristic to automatically select the most computationally efficient approach. Joint ordinal continuous SEM is implemented in OpenMx, free and open-source software.

Randomized Study Comparing the Effect of Carbon Dioxide Insufflation on Veins Using 2 Types of Endoscopic and Open Vein Harvesting.

PubMed

Krishnamoorthy, Bhuvaneswari; Critchley, William R; Nair, Janesh; Malagon, Ignacio; Carey, John; Barnard, James B; Waterworth, Paul D; Venkateswaran, Rajamiyer V; Fildes, James E; Caress, Ann L; Yonan, Nizar

The aim of the study was to assess whether the use of carbon dioxide insufflation has any impact on integrity of long saphenous vein comparing 2 types of endoscopic vein harvesting and traditional open vein harvesting. A total of 301 patients were prospectively randomized into 3 groups. Group 1 control arm of open vein harvesting (n = 101), group 2 closed tunnel (carbon dioxide) endoscopic vein harvesting (n = 100) and Group 3 open tunnel (carbon dioxide) endoscopic vein harvesting (open tunnel endoscopic vein harvesting) (n = 100). Each group was assessed to determine the systemic level of partial arterial carbon dioxide, end-tidal carbon dioxide, and pH. Three blood samples were obtained at baseline, 10 minutes after start of endoscopic vein harvesting, and 10 minutes after the vein was retrieved. Vein samples were taken immediately after vein harvesting without further surgical handling to measure the histological level of endothelial damage. A modified validated endothelial scoring system was used to compare the extent of endothelial stretching and detachment. The level of end-tidal carbon dioxide was maintained in the open tunnel endoscopic vein harvesting and open vein harvesting groups but increased significantly in the closed tunnel endoscopic vein harvesting group (P = 0.451, P = 0.385, and P < 0.001). Interestingly, partial arterial carbon dioxide also did not differ over time in the open tunnel endoscopic vein harvesting group (P = 0.241), whereas partial arterial carbon dioxide reduced significantly over time in the open vein harvesting group (P = 0.001). A profound increase in partial arterial carbon dioxide was observed in the closed tunnel endoscopic vein harvesting group (P < 0.001). Consistent with these patterns, only the closed tunnel endoscopic vein harvesting group demonstrated a sudden drop in pH over time (P < 0.001), whereas pH remained stable for both open tunnel endoscopic vein harvesting and open vein harvesting groups (P = 0.105 and P = 0.869, respectively). Endothelial integrity was better preserved in the open vein harvesting group compared with open tunnel endoscopic vein harvesting or closed tunnel endoscopic vein harvesting groups (P = 0.012) and was not affected by changes in carbon dioxide or low pH. Significantly greater stretching of the endothelium was observed in the open tunnel endoscopic open tunnel endoscopic vein harvesting group compared with the other groups (P = 0.003). This study demonstrated that the different vein harvesting techniques impact on endothelial integrity; however, this does not seem to be related to the increase in systemic absorption of carbon dioxide or to the pressurized endoscopic tunnel. The open tunnel endoscopic harvesting technique vein had more endothelial stretching compared with the closed tunnel endoscopic technique; this may be due to manual dissection of the vein. Further research is required to evaluate the long-term clinical outcome of these vein grafts.

Percutaneous nephrolithotomy with one-shot dilation method: Is it safe in patients who had open surgery before?

PubMed

Süelözgen, Tufan; Isoglu, Cemal Selcuk; Turk, Hakan; Yoldas, Mehmet; Karabicak, Mustafa; Ergani, Batuhan; Boyacioglu, Hayal; Ilbey, Yusuf Ozlem; Zorlu, Ferruh

2016-01-01

This study aimed to evaluate whether one-shot dilatation technique is as safe in patients with a history of open-stone surgery as it is in patients without previous open-stone surgery. Between January 2007 and February 2015, 82 patients who underwent percutaneous nephrolithotomy (PNL) surgery with one-shot dilation technique who previously had open-stone surgery were retrospectively reviewed and evaluated (Group 1). Another 82 patients were selected randomly among patients who had PNL with one-shot dilation technique, but with no history of open renal surgery (Group 2). Age, gender, type of kidney stone, duration of surgery, radiation exposure time, and whether or not there was any bleeding requiring perioperative and postoperative transfusion were noted for each patient. The stone-free rates, operation and fluoroscopy time, and peroperative and postoperative complication rates were similar in both groups (p>0.05). Our experience indicated that PNL with one-shot dilation technique is a reliable method in patients with a history of open-stone surgery.

The Advanced Glaucoma Intervention Study (AGIS): 3. Baseline characteristics of black and white patients.

PubMed

1998-07-01

The purpose of this report is to examine the differences at baseline in demographic, medical, and ophthalmic characteristics between blacks and whites enrolled in the Advanced Glaucoma Intervention Study (AGIS), a multicenter, randomized, clinical trial. Multicenter, randomized, controlled trial. A total of 332 black patients (451 eyes), 249 white patients (325 eyes), and 10 patients of other races (13 eyes) with open-angle glaucoma that could not be controlled by medical therapy alone participated. There was no intervention performed. The investigators compare the baseline demographic, medical, and ophthalmic characteristics of black and white patients, adjusting the comparisons for age and gender. Blacks in the study were younger than whites and had more systemic hypertension and diabetes than whites. The visual field defects of blacks on average were substantially more severe than those of whites. Intraocular pressures and visual acuity scores were similar in the two groups. Blacks were more hyperopic and had relatively fewer disk rim hemorrhages than whites. The findings of the current study concur with those of previous clinical studies of open-angle glaucoma that visual field defects are more severe in blacks than whites.

EIA: Educational Reform or Repression?

ERIC Educational Resources Information Center

Monteith, Dianne S.

A recent study (Cook, 1989) involving 58 randomly selected South Carolina elementary schools indicated that none of these schools could be characterized as having an "open climate." This paper suggests that this situation may have its origins in the educational reform movement of the 1980s, first ignited by the publication of "A…

Doxycycline for prevention of erlotinib-induced rash in patients with non-small-cell lung cancer (NSCLC) after failure of first-line chemotherapy: A randomized, open-label trial.

PubMed

Deplanque, Gaël; Gervais, Radj; Vergnenegre, Alain; Falchero, Lionel; Souquet, Pierre-Jean; Chavaillon, Jean-Michel; Taviot, Bruno; Fraboulet, Ghislaine; Saal, Hakim; Robert, Caroline; Chosidow, Olivier

2016-06-01

Rash is a common epidermal growth factor receptor inhibitor-induced toxicity that can impair quality of life and treatment compliance. We sought to evaluate the efficacy of doxycycline in preventing erlotinib-induced rash (folliculitis) in patients with non-small-cell lung cancer. This open-label, randomized, prospective, phase II trial was conducted in 147 patients with locally advanced or metastatic non-small-cell lung cancer progressing after first-line chemotherapy, randomized for 4 months with erlotinib alone 150 mg/d per os (control arm) or combined with doxycycline 100 mg/d (doxycycline arm). Incidence and severity of rash, compliance, survival, and safety were assessed. Baseline characteristics of the 147 patients were well balanced in the intent-to-treat population. Folliculitis occurred in 71% of patients in the doxycycline arm and 81% in the control arm (P = .175). The severity of folliculitis and other skin lesions was lower in the doxycycline arm compared with the control arm. Other adverse events were reported at a similar frequency across arms. There was no significant difference in survival between treatment arms. The open-label design of the study and the duration of the treatment with doxycycline are limitations. Doxycycline did not reduce the incidence of erlotinib-induced folliculitis, but significantly reduced its severity. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Randomized controlled trial of ethyl-eicosapentaenoic acid in Huntington disease: the TREND-HD study.

PubMed

2008-12-01

To determine whether ethyl-eicosapentaenoic acid (ethyl-EPA), an omega-3 fatty acid, improves the motor features of Huntington disease. Six-month multicenter, randomized, double-blind, placebo-controlled trial followed by a 6-month open-label phase without disclosing initial treatment assignments. Forty-one research sites in the United States and Canada. Three hundred sixteen adults with Huntington disease, enriched for a population with shorter trinucleotide (cytosine-adenine-guanine) repeat length expansions. Random assignment to placebo or ethyl-EPA, 1 g twice a day, followed by open-label treatment with ethyl-EPA. Six-month change in the Total Motor Score 4 component of the Unified Huntington's Disease Rating Scale analyzed for all research participants and those with shorter cytosine-adenine-guanine repeat length expansions (<45). At 6 months, the Total Motor Score 4 point change for patients receiving ethyl-EPA did not differ from that for those receiving placebo. No differences were found in measures of function, cognition, or global impression. Before public disclosure of the 6-month placebo-controlled results, 192 individuals completed the open-label phase. The Total Motor Score 4 change did not worsen for those who received active treatment for 12 continuous months compared with those who received active treatment for only 6 months (2.0-point worsening; P=.02). Ethyl-EPA was not beneficial in patients with Huntington disease during 6 months of placebo-controlled evaluation. Clinical Trial Registry clinicaltrials.gov Identifier: NCT00146211.

EEG alpha asymmetry as a gender-specific predictor of outcome to acute treatment with different antidepressant medications in the randomized iSPOT-D study.

PubMed

Arns, Martijn; Bruder, Gerard; Hegerl, Ulrich; Spooner, Chris; Palmer, Donna M; Etkin, Amit; Fallahpour, Kamran; Gatt, Justine M; Hirshberg, Laurence; Gordon, Evian

2016-01-01

To determine whether EEG occipital alpha and frontal alpha asymmetry (FAA) distinguishes outpatients with major depression (MDD) from controls, predicts antidepressant treatment outcome, and to explore the role of gender. In the international Study to Predict Optimized Treatment in Depression (iSPOT-D), a multi-center, randomized, prospective open-label trial, 1008 MDD participants were randomized to escitalopram, sertraline or venlafaxine-extended release. The study also recruited 336 healthy controls. Treatment response was established after eight weeks and resting EEG was measured at baseline (two minutes eyes open and eyes closed). No differences in EEG alpha for occipital and frontal cortex, or for FAA, were found in MDD participants compared to controls. Alpha in the occipital and frontal cortex was not associated with treatment outcome. However, a gender and drug-class interaction effect was found for FAA. Relatively greater right frontal alpha (less cortical activity) in women only was associated with a favorable response to the Selective Serotonin Reuptake Inhibitors escitalopram and sertraline. No such effect was found for venlafaxine-extended release. FAA does not differentiate between MDD and controls, but is associated with antidepressant treatment response and remission in a gender and drug-class specific manner. Future studies investigating EEG alpha measures in depression should a-priori stratify by gender. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Comparison of acarbose and voglibose in diabetes patients who are inadequately controlled with basal insulin treatment: randomized, parallel, open-label, active-controlled study.

PubMed

Lee, Mi Young; Choi, Dong Seop; Lee, Moon Kyu; Lee, Hyoung Woo; Park, Tae Sun; Kim, Doo Man; Chung, Choon Hee; Kim, Duk Kyu; Kim, In Joo; Jang, Hak Chul; Park, Yong Soo; Kwon, Hyuk Sang; Lee, Seung Hun; Shin, Hee Kang

2014-01-01

We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). The mean HbA1c at week 24 was significantly decreased approximately 0.7% from baseline in both acarbose (from 8.43% ± 0.71% to 7.71% ± 0.93%) and voglibose groups (from 8.38% ± 0.73% to 7.68% ± 0.94%). The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 ± 69.38 to 176.80 ± 46.63 mg/dL) compared with the voglibose group (from 224.18 ± 70.07 to 193.01 ± 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528).

Comparison of Acarbose and Voglibose in Diabetes Patients Who Are Inadequately Controlled with Basal Insulin Treatment: Randomized, Parallel, Open-Label, Active-Controlled Study

PubMed Central

Lee, Mi Young; Lee, Moon Kyu; Lee, Hyoung Woo; Park, Tae Sun; Kim, Doo Man; Chung, Choon Hee; Kim, Duk Kyu; Kim, In Joo; Jang, Hak Chul; Park, Yong Soo; Kwon, Hyuk Sang; Lee, Seung Hun; Shin, Hee Kang

2014-01-01

We studied the efficacy and safety of acarbose in comparison with voglibose in type 2 diabetes patients whose blood glucose levels were inadequately controlled with basal insulin alone or in combination with metformin (or a sulfonylurea). This study was a 24-week prospective, open-label, randomized, active-controlled multi-center study. Participants were randomized to receive either acarbose (n=59, 300 mg/day) or voglibose (n=62, 0.9 mg/day). The mean HbA1c at week 24 was significantly decreased approximately 0.7% from baseline in both acarbose (from 8.43% ± 0.71% to 7.71% ± 0.93%) and voglibose groups (from 8.38% ± 0.73% to 7.68% ± 0.94%). The mean fasting plasma glucose level and self-monitoring of blood glucose data from 1 hr before and after each meal were significantly decreased at week 24 in comparison to baseline in both groups. The levels 1 hr after dinner at week 24 were significantly decreased in the acarbose group (from 233.54 ± 69.38 to 176.80 ± 46.63 mg/dL) compared with the voglibose group (from 224.18 ± 70.07 to 193.01 ± 55.39 mg/dL). In conclusion, both acarbose and voglibose are efficacious and safe in patients with type 2 diabetes who are inadequately controlled with basal insulin. (ClinicalTrials.gov number, NCT00970528) PMID:24431911

The Current Indication for Pacemaker in Patients with Cardioinhibitory Vasovagal Syncope

PubMed Central

da Silva, Rose Mary Ferreira Lisboa

2016-01-01

The most frequent cause of syncope is vasovagal reflex. It is associated with worse quality of life, depression, fatigue and physical injury. Recurrence of vasovagal syncope is an aggravating, reaching the rate of 69%. Initial step and pharmacological treatment may not work, especially in patients with recurrent syncope without prodrome. These patients can present cardioinhibitory response with asystole. Studies were designed to analyses the effectiveness of pacemaker for prevention of syncope. In this review, nonrandomized clinical trials, open-label randomized, double-blind randomized, placebo-controlled, and studies based on tilt test or Implantable Loop Recorder findings will be discussed. PMID:27651841

Is there a role for e-cigarettes in smoking cessation?

PubMed

Leduc, Charlotte; Quoix, Elisabeth

2016-04-01

The use of e-cigarettes has dramatically increased over the past few years and their role in smoking cessation remains controversial. Several clinical studies have evaluated their efficacy in smoking cessation but most of them are prospective cohort studies. Only two randomized, controlled trials have compared e-cigarettes versus placebo or patches. A meta-analysis of these two randomized, controlled trials has been performed. Nicotine-containing e-cigarettes appear to help smokers unable to stop smoking altogether to reduce their cigarette consumption when compared with placebo. However, these results are rated 'low' by GRADE standards. Many cohort studies have been conducted, with contradictory results. For some, e-cigarettes could increase the risk of nonsmokers developing nicotine dependence and of current smokers maintaining their dependence. The debate remains open and more randomized trials are needed with long-term data about the efficacy and safety of e-cigarettes. © The Author(s), 2015.

Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years.

PubMed

Powell, J T; Sweeting, M J; Ulug, P; Blankensteijn, J D; Lederle, F A; Becquemin, J-P; Greenhalgh, R M

2017-02-01

The erosion of the early mortality advantage of elective endovascular aneurysm repair (EVAR) compared with open repair of abdominal aortic aneurysm remains without a satisfactory explanation. An individual-patient data meta-analysis of four multicentre randomized trials of EVAR versus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention. The analysis included 2783 patients, with 14 245 person-years of follow-up (median 5·5 years). Early (0-6 months after randomization) mortality was lower in the EVAR groups (46 of 1393 versus 73 of 1390 deaths; pooled hazard ratio 0·61, 95 per cent c.i. 0·42 to 0·89; P = 0·010), primarily because 30-day operative mortality was lower in the EVAR groups (16 deaths versus 40 for open repair; pooled odds ratio 0·40, 95 per cent c.i. 0·22 to 0·74). Later (within 3 years) the survival curves converged, remaining converged to 8 years. Beyond 3 years, aneurysm-related mortality was significantly higher in the EVAR groups (19 deaths versus 3 for open repair; pooled hazard ratio 5·16, 1·49 to 17·89; P = 0·010). Patients with moderate renal dysfunction or previous coronary artery disease had no early survival advantage under EVAR. Those with peripheral artery disease had lower mortality under open repair (39 deaths versus 62 for EVAR; P = 0·022) in the period from 6 months to 4 years after randomization. The early survival advantage in the EVAR group, and its subsequent erosion, were confirmed. Over 5 years, patients of marginal fitness had no early survival advantage from EVAR compared with open repair. Aneurysm-related mortality and patients with low ankle : brachial pressure index contributed to the erosion of the early survival advantage for the EVAR group. Trial registration numbers: EVAR-1, ISRCTN55703451; DREAM (Dutch Randomized Endovascular Aneurysm Management), NCT00421330; ACE (Anévrysme de l'aorte abdominale, Chirurgie versus Endoprothèse), NCT00224718; OVER (Open Versus Endovascular Repair Trial for Abdominal Aortic Aneurysms), NCT00094575. © 2017 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

An Open-Label Randomized Control Trial of Hopping and Jumping Training versus Sensorimotor Rehabilitation Programme on Postural Capacities in Individuals with Intellectual Disabilities

ERIC Educational Resources Information Center

Borji, Rihab; Sahli, Sonia; Baccouch, Rym; Laatar, Rabeb; Kachouri, Hiba; Rebai, Haithem

2018-01-01

Background: This study aimed to compare the effectiveness of a hopping and jumping training programme (HJP) versus a sensorimotor rehabilitation programme (SRP) on postural performances in children with intellectual disability. Methods: Three groups of children with intellectual disability participated in the study: the HJP group, the SRP group…

An Experimental Study on the Effects of a Simulation Game on Students' Clinical Cognitive Skills and Motivation

ERIC Educational Resources Information Center

Dankbaar, Mary E. W.; Alsma, Jelmer; Jansen, Els E. H.; van Merrienboer, Jeroen J. G.; van Saase, Jan L. C. M.; Schuit, Stephanie C. E.

2016-01-01

Simulation games are becoming increasingly popular in education, but more insight in their critical design features is needed. This study investigated the effects of fidelity of open patient cases in adjunct to an instructional e-module on students' cognitive skills and motivation. We set up a three-group randomized post-test-only design: a…

Neither Orthodoxy nor Randomness: Differing Logics of Conducting Comparative and International Studies in Education

ERIC Educational Resources Information Center

Schriewer, Jürgen

2014-01-01

The issue of the presumed "identity" of Comparative Education as a field of study or a discipline has been discussed for decades. Yet what remains open to question is a kind of systematic structure that provides the basic principles for a coherent exposition of the field. After conceptualising and rejecting almost a dozen possible…

Effects of prenatal stress on vulnerability to stress in prepubertal and adult rats.

PubMed

Fride, E; Dan, Y; Feldon, J; Halevy, G; Weinstock, M

1986-01-01

This study investigated the hypotheses that unpredictable prenatal stress has effects on the offspring, similar to those induced by perinatal administration of glucocorticoids and increases the vulnerability to stressful situations at adulthood. Rats were exposed to random noise and light stress throughout pregnancy. Offspring were tested for the development of spontaneous alternation behavior (SA) and at adulthood, their response to novel or aversive situations, open field, extinction and punishment following acquisition of an appetitive response and two-way active avoidance, were assessed. In prenatally stressed rats, the development of SA was significantly delayed. On repeated exposure to an open field they were less active; control rats had elevated plasma corticosterone (CCS) on days 2 and 4 of open field exposure, while prenatally stressed rats had significantly raised plasma CCS after each exposure (days 1-8). Furthermore, punishment-induced suppression of an appetitive response was enhanced. Acquisition of active avoidance was faciliated in female but reduced in male prenatally stressed offspring. It is suggested that random prenatal noise and light stress may cause impairment of development of hippocampal function which lasts into adulthood. This impairment is manifested as an increase in vulnerability and a decrease in habituation to stressful stimuli.

Introductory Statistics Students' Conceptual Understanding of Study Design and Conclusions

NASA Astrophysics Data System (ADS)

Fry, Elizabeth Brondos

Recommended learning goals for students in introductory statistics courses include the ability to recognize and explain the key role of randomness in designing studies and in drawing conclusions from those studies involving generalizations to a population or causal claims (GAISE College Report ASA Revision Committee, 2016). The purpose of this study was to explore introductory statistics students' understanding of the distinct roles that random sampling and random assignment play in study design and the conclusions that can be made from each. A study design unit lasting two and a half weeks was designed and implemented in four sections of an undergraduate introductory statistics course based on modeling and simulation. The research question that this study attempted to answer is: How does introductory statistics students' conceptual understanding of study design and conclusions (in particular, unbiased estimation and establishing causation) change after participating in a learning intervention designed to promote conceptual change in these areas? In order to answer this research question, a forced-choice assessment called the Inferences from Design Assessment (IDEA) was developed as a pretest and posttest, along with two open-ended assignments, a group quiz and a lab assignment. Quantitative analysis of IDEA results and qualitative analysis of the group quiz and lab assignment revealed that overall, students' mastery of study design concepts significantly increased after the unit, and the great majority of students successfully made the appropriate connections between random sampling and generalization, and between random assignment and causal claims. However, a small, but noticeable portion of students continued to demonstrate misunderstandings, such as confusion between random sampling and random assignment.

A Randomized Study Comparing the Shaker Exercise with Traditional Therapy: A Preliminary Study

PubMed Central

Rademaker, Alfred; Pauloski, Barbara Roa; Kelly, Amy; Stangl-McBreen, Carrie; Antinoja, Jodi; Grande, Barbara; Farquharson, Julie; Kern, Mark; Easterling, Caryn; Shaker, Reza

2010-01-01

Seven institutions participated in this small clinical trial that included 19 patients who exhibited oropharyngeal dysphagia on videofluorography (VFG) involving the upper esophageal sphincter (UES) and who had a 3-month history of aspiration. All patients were randomized to either traditional swallowing therapy or the Shaker exercise for 6 weeks. Each patient received a modified barium swallow pre- and post-therapy, including two swallows each of 3 ml and 5 ml liquid barium and 3 ml barium pudding. Each videofluorographic study was sent to a central laboratory and digitized in order to measure hyoid and larynx movement as well as UES opening. Fourteen patients received both pre-and post-therapy VFG studies. There was significantly less aspiration post-therapy in patients in the Shaker group. Residue in the various oral and pharyngeal locations did not differ between the groups. With traditional therapy, there were several significant increases from pre- to post-therapy, including superior laryngeal movement and superior hyoid movement on 3-ml pudding swallows and anterior laryngeal movement on 3-ml liquid boluses, indicating significant improvement in swallowing physiology. After both types of therapy there is a significant increase in UES opening width on 3-ml paste swallows. PMID:19472007

Sniffing position combined with mouth opening improves facemask ventilation in children with adenotonsillar hypertrophy.

PubMed

Cuvas, O; Dikmen, B; Yucel, F

2011-05-01

This study evaluates the influence of sniffing position combined with mouth opening on the effectiveness of facemask ventilation in paralyzed pediatric patients undergoing adenotonsillectomy during sevoflurane-N(2)O anesthesia. After Institutional Ethics Committee approval, 40 children 5-11 years of age who were scheduled for an elective adenotonsillectomy operation were enrolled in this prospective randomized study. After routine monitoring and pre-oxygenation, anesthesia was induced with sevoflurane 8% in a mixture of 50% N(2)O-O(2). Three minutes after the administration of vecuronium, the sequence of the positions was randomized. Three positions were applied during facemask ventilation: Position CN (closed mouth - neutral head and neck position), position CS (closed mouth-sniffing position) and position OS (opened mouth-sniffing position). Volume-controlled ventilation was started. Peak inspiratory pressure (PIP), tidal volume (V(T)), expired tidal volume (V(Texp)) and end-tidal CO(2) pressure were recorded. The percent of leakage was calculated. The primary endpoint of this study was the expired tidal volume (V(Texp)). There was a statistically significant difference among the three positions for V(Texp) and PIP values. The OS resulted in higher V(Texp) values when compared with CN (P=0.022). The OS was significantly better than the other two positions, resulting in lower PIP values (P<0.001 and P=0.004, for CN and CS, respectively). The OS also resulted in less leakage during facemask ventilation when compared with CN and CS. Sniffing position combined with mouth opening improves V(Texp) and PIP values during facemask ventilation during sevoflurane-N(2)O anesthesia in paralyzed pediatric patients with adenotonsillar hypertrophy.

A Randomized Trial Comparing Stapled Rectal Mucosectomy Versus Open and Semiclosed Hemorrhoidectomy.

PubMed

Ripetti, Valter; La Vaccara, Vincenzo; Greco, Santi; Arullani, Augusto

2015-11-01

Different results have been reported concerning the postoperative outcomes of different surgical approaches for hemorrhoids. We aimed to determine the postoperative outcome following 3 main surgical techniques. A prospective, randomized trial was designed with 180 patients in 3 arms of 60 patients each. The study was conducted from April 1999 to January 2007 at the University Hospital "Campus Bio-Medico di Roma." All of the patients who were referred for hemorrhoid surgery were enrolled according to inclusion and exclusion criteria (ISRCTN12040297). Treatments according to the open, semiclosed, and stapled techniques were compared. Sample size was calculated to determine a difference in terms of the intensity of postoperative pain at the first week and the days required for return to work activity. After 1 week, patients who underwent semiclosed hemorrhoidectomy reported significantly less pain (p < 0.01) and a significant decrease in analgesic intake from the third postoperative day (p < 0.01) than after the other 2 techniques. The patients resumed work ≈11 days after semiclosed and stapled techniques (11.8 and 11.6 days), which was earlier compared with 21.3 days in the open group (p < 0.05). The high number of patients excluded might be considered a limitation of the study, but our selection criteria including patients living within 50 km of the hospital allowed for a low rate (9.4%) of patients lost to follow-up. This study found an earlier resumption of work and less pain in patients who underwent the stapled and semiclosed procedures rather than open, which was associated with more complications, particularly because of a higher rate of stenosis (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A196).

Pilot Study of Droxidopa With Carbidopa in Adults With ADHD.

PubMed

Adler, Lenard A; Gorny, Stephen W

2015-04-23

We conducted a two-period (open-label and double-blind) pilot investigation of droxidopa, with and without carbidopa, for ADHD. Twenty adult ADHD patients received open-label droxidopa titrated from 200 to 600 mg 3 times per day (TID; Weeks 1-3), then open-label droxidopa plus carbidopa titrated from 25 or 50 mg TID (Weeks 4-6). In Weeks 7 to 8, patients were randomized to continued co-treatment or matching placebo substitution. Improvements in mean total Adult ADHD Investigator Symptom Report Scale (AISRS) scores were seen at Week 1 (p < .0001) and Week 3 (p < .0001). Improvements were maintained but not increased with carbidopa. Thirteen of 20 patients completed open-label treatment. In the double-blind period, mean total AISRS scores were similar between the co-treatment (n = 6) and placebo (n = 5) groups. No serious adverse events were reported. These preliminary findings indicate that droxidopa can improve adult ADHD symptoms. Further studies are warranted to examine the efficacy and safety of droxidopa in ADHD. © 2015 SAGE Publications.

Comparison of closed-ended, open-ended, and perceived informed consent comprehension measures for a mock HIV prevention trial among women in Tanzania.

PubMed

MacQueen, Kathleen M; Chen, Mario; Ramirez, Catalina; Nnko, Soori E A; Earp, Kelly M

2014-01-01

Verifying participant comprehension continues to be a difficult ethical and regulatory challenge for clinical research. An increasing number of articles assessing methods to improve comprehension have been published, but they use a wide range of outcome measures including open-ended, closed-ended, and self-perceived measures of comprehension. Systematic comparisons of different measures have rarely been reported. This study evaluated the likely direction of bias observed when using open-ended, closed-ended, and perceived ease of comprehension measures among women administered a mock informed consent process in Mwanza, Tanzania. Participants were randomized to either a closed-ended or an open-ended assessment of comprehension, administered the consent process for a hypothetical HIV prevention trial in Kiswahili, and then administered a comprehension assessment, per their randomization. They were then asked how easy or hard it was to understand each of the informed consent components measured in the comprehension assessment. Women in the closed-ended arm had significantly higher overall comprehension scores than in the open-ended arm. Perceived scores were significantly higher when compared to both open-ended and close-ended scores within arms but were similar between arms. Findings highlight the importance of comprehension assessments in complex clinical trials that go beyond asking participants if they understand or have any questions. They also indicate the need for continued exploration of objective measures of comprehension in international clinical research settings, so that points in need of clarification can be efficiently and effectively identified and addressed. Such measures would reduce burdens on both staff and participants that result from well-intentioned but potentially unnecessary time spent explaining in unwarranted detail things already understood.

Interest of intra-operative 3D imaging in spine surgery: a prospective randomized study.

PubMed

Ruatti, Sébastien; Dubois, C; Chipon, E; Kerschbaumer, G; Milaire, M; Moreau-Gaudry, A; Tonetti, J; Merloz, Ph

2016-06-01

We report a single-center, prospective, randomized study for pedicle screw insertion in opened and percutaneous spine surgeries, using a computer-assisted surgery (CAS) technique with three-dimensional (3D) intra-operative images intensifier (without planification on pre-operative CT scan) vs conventional surgical procedure. We included 143 patients: Group C (conventional, 72 patients) and Group N (3D Fluoronavigation, 71 patients). We measured the pedicle screw running time, and surgeon's radiation exposure. All pedicle runs were assessed according to Heary by two independent radiologists on a post-operative CT scan. 3D Fluoronavigation appeared less accurate in percutaneous procedures (24 % of misplaced pedicle screws vs 5 % in Group C) (p = 0.007), but more accurate in opened surgeries (5 % of misplaced pedicle screws vs 17 % in Group C) (p = 0.025). For one vertebra, the average surgical running time reached 8 min in Group C vs 21 min in Group N for percutaneous surgeries (p = 3.42 × 10(-9)), 7.33 min in Group C vs 16.33 min in Group N (p = 2.88 × 10(-7)) for opened surgeries. The 3D navigation device delivered less radiation in percutaneous procedures [0.6 vs 1.62 mSv in Group C (p = 2.45 × 10(-9))]. For opened surgeries, it was twice higher in Group N with 0.21 vs 0.1 mSv in Group C (p = 0.022). The rate of misplaced pedicle screws with conventional techniques was nearly the same as most papers and a little bit higher with CAS. Surgical running time and radiation exposure were consistent with many studies. Our work hypothesis is partially confirmed, depending on the type of surgery (opened or closed procedure).

Randomized Withdrawal Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension Responsive to Droxidopa

PubMed Central

Freeman, Roy; Mathias, Christopher J.; Low, Phillip; Hewitt, L. Arthur; Kaufmann, Horacio

2015-01-01

Abstract— We evaluated whether droxidopa, a prodrug converted to norepinephrine, is beneficial in the treatment of symptomatic neurogenic orthostatic hypotension, which results from failure to generate an appropriate norepinephrine response to postural challenge. Patients with symptomatic neurogenic orthostatic hypotension and Parkinson disease, multiple system atrophy, pure autonomic failure, or nondiabetic autonomic neuropathy underwent open-label droxidopa titration (100–600 mg, 3× daily). Responders then received an additional 7-day open-label treatment at their individualized dose. Patients were subsequently randomized to continue with droxidopa or withdraw to placebo for 14 days. We then assessed patient-reported scores on the Orthostatic Hypotension Questionnaire and blood pressure measurements. Mean worsening of Orthostatic Hypotension Questionnaire dizziness/lightheadedness score from randomization to end of study (the primary outcome; N=101) was 1.9±3.2 with placebo and 1.3±2.8 units with droxidopa (P=0.509). Four of the other 5 Orthostatic Hypotension Questionnaire symptom scores and all 4 symptom-impact scores favored droxidopa, with statistical significance for the patient’s self-reported ability to perform activities requiring standing a short time (P=0.033) and standing a long time (P=0.028). Furthermore, a post hoc analysis of a predefined composite score of all symptoms (Orthostatic Hypotension Questionnaire composite) demonstrated a significant benefit for droxidopa (P=0.013). There was no significant difference between groups for standing systolic blood pressure (P=0.680). Droxidopa was well tolerated. In summary, this randomized withdrawal droxidopa study failed to meet its primary efficacy end point. Additional clinical trials are needed to confirm that droxidopa is beneficial in symptomatic neurogenic orthostatic hypotension, as suggested by the positive secondary outcomes of this trial. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT00633880. PMID:25350981

Supplemental Peri-Operative Oxygen and Incision Site Infection after Surgery for Perforated Peptic Ulcer: A Randomized, Double-Blind Monocentric Trial.

PubMed

Schietroma, Mario; Cecilia, Emanuela Marina; De Santis, Giuseppe; Carlei, Francesco; Pessia, Beatrice; Amicucci, Gianfranco

2016-02-01

The clinical role of hyperoxia for preventing surgical site infection (SSI) remains uncertain because randomized controlled trials on this topic have reported disparate results. One of the principal reasons for this outcome may be that prior trials have entered heterogeneous populations of patients and a variety of procedures. The aim of our study was to assess the influence of hyperoxygenation on SSI using a homogeneous study population. From January 2004 to April 2013, we studied, in a randomized trial, 239 patients, who underwent open surgery for perforated peptic ulcer (PPU). The surgical procedure was performed through an upper abdominal midline incision, and closure of PPU was achieved by suture alone or in combination with an omental patch. Patients were assigned randomly to an oxygen/air mixture with a fraction of inspired oxygen (FiO2) of 30% (n = 120) or 80% (n = 119). Administration was commenced after induction of anesthesia and maintained for 6 hours after surgery. The overall incision infection rate was 38.4% (92 of 239): 61 patients (50.8%) had an infection in the 30% FiO2 group and 31 (26%) in the 80% FiO2 group (p < 0.05). The risk of SSI was 48% lower in the 80% FiO2 group (relative risk 0.51; 95% confidence interval [CI] 0.28-1.08) vs 30% FiO2. Supplemental 80% FiO2 during and for 6 h after open surgery for PPU, which reduces post-operative SSI, should be considered part of ongoing quality improvement activities related to surgical care, with few risks to the patient and little associated cost.

A prospective study of the impact of opening a casino on gambling behaviours: 2- and 4-year follow-ups.

PubMed

Jacques, Christian; Ladouceur, Robert

2006-10-01

It is widely believed that the rate of pathological gambling is related to the accessibility and availability of gambling activities. Few empirical studies have yet been conducted to evaluate this hypothesis. Using a longitudinal prospective design, the current study evaluates the impact of a casino in Canada's Hull, Quebec region. A random sample of respondents from Hull (experimental group) and from Quebec City (comparison group) completed the South Oaks Gambling Screen (SOGS) and gambling- related questions before the opening of the Hull Casino (pretest), 1 year after the opening (posttest), and on follow-up at Years 2 and 4. Although, 1 year after the opening of the casino, we did observe an increase in playing casino games and in the maximum amount of money lost in 1 day's gambling, this trend was not maintained over time (2- and 4-year follow-ups). In the Hull cohort, the rate of at-risk and probable pathological gamblers and the number of criteria on the SOGS did not increase at the 2- and 4-year follow-ups. The residents' reluctance to open a local casino was generally stable over time following the casino's opening. The discussion raises different explanatory factors and focuses on the context of the Regional Exposure Model as a potentially more applicable measure of studying the expansion of gambling.

Cognitive enhancement treatments for bipolar disorder: A systematic review and methodological recommendations.

PubMed

Miskowiak, Kamilla W; Carvalho, André F; Vieta, Eduard; Kessing, Lars V

2016-10-01

Cognitive dysfunction is an emerging treatment target in bipolar disorder (BD). Several trials have assessed the efficacy of novel pharmacological and psychological treatments on cognition in BD but the findings are contradictory and unclear. A systematic search following the PRISMA guidelines was conducted on PubMed and PsychInfo. Eligible articles reported randomized, controlled or open-label trials investigating pharmacological or psychological treatments targeting cognitive dysfunction in BD. The quality of the identified randomized controlled trials (RCTs) was evaluated with the Cochrane Collaboration's Risk of Bias tool. We identified 19 eligible studies of which 13 were RCTs and six were open-label or non-randomized studies. The findings regarding efficacy on cognition were overall disappointing or preliminary, possibly due to several methodological challenges. For the RCTs, the risk of bias was high in nine cases, unclear in one case and low in three cases. Key reasons for the high risk of bias were lack of details on the randomization process, suboptimal handling of missing data and lack of a priori priority between cognition outcomes. Other challenges were the lack of consensus on whether and how to screen for cognitive impairment and on how to assess efficacy on cognition. In conclusion, methodological problems are likely to impede the success rates of cognition trials in BD. We recommend adherence to the CONSORT guidelines for RCTs, screening for cognitive impairment before inclusion of trial participants and selection of one primary cognition outcome. Future implementation of a 'neurocircuitry-based' biomarker model to evaluate neural target engagement is warranted. Copyright © 2016 Elsevier B.V. and ECNP. All rights reserved.

Influence of intestinal bacterial decontamination using metronidazole and ciprofloxacin or ciprofloxacin alone on the development of acute graft-versus-host disease after marrow transplantation in patients with hematologic malignancies: final results and long-term follow-up of an open-label prospective randomized trial.

PubMed

Beelen, D W; Elmaagacli, A; Müller, K D; Hirche, H; Schaefer, U W

1999-05-15

In a single-center open-label prospective study, a total of 134 marrow transplant recipients with hematologic malignancies were randomly assigned to a bacterial decontamination medication using metronidazole and ciprofloxacin (n = 68) or ciprofloxacin alone (n = 66) during 5 weeks posttransplant. The development of grades II to IV acute graft-versus-host disease (GVHD) was defined as the primary study endpoint. According to the intention-to-treat, 17 patients (25%) randomized to the combined decontamination medication and 33 patients (50%) randomized to ciprofloxacin alone developed grades II to IV GVHD (P <.002). The higher frequency of grades II to IV acute GVHD in patients randomized to ciprofloxacin alone resulted from a more than twofold increased number of patients developing liver or intestinal involvement with acute GVHD compared with patients randomized to the combined decontamination medication (P <.003). The influence of the study medication on grades II to IV acute GVHD was significant only in recipients of transplants from genotypically HLA-identical sibling donors (n = 80), whereas in recipients of transplants from donors other than HLA-identical siblings (n = 54), grades II to IV acute GVHD frequencies between the study arms were not significantly different. The combined decontamination was associated with a significant reduction of culture growth of intestinal anaerobic bacteria during 5 weeks posttransplant (P <. 00001). In addition, the number of cultures with growth of anaerobic bacteria (P <.005) as well as the median concentrations of anaerobic bacteria in the posttransplant period (P <.0001) were higher in patients contracting grades II to IV acute GVHD. Neither chronic GVHD nor overall survival was significantly different between the two study arms. In patients with HLA-identical sibling donors who were treated in early disease stages, the 5-year survival estimate was slightly, but not significant, higher after the combined decontamination medication (60% +/- 11%) compared with ciprofloxacin alone (46% +/- 9%). In conclusion, the present study provides evidence that antimicrobial chemotherapy targeted to intestinal anaerobic bacteria in marrow transplant recipients significantly reduces the severity of acute GVHD and supports the theory that the intestinal anaerobic bacterial microflora plays a role in the pathogenesis of acute GVHD after human marrow transplantation.

Clinical trials in rheumatoid arthritis: a status report from the ClinicalTrials.gov website.

PubMed

Paul, Jisna R; Ranganathan, Prabha

2012-06-01

The aims of this study are to describe the characteristics of clinical trials in rheumatoid arthritis (RA) listed in ClinicalTrials.gov and examine existing trends in study design, funding sources, outcomes, and drugs under investigation. We conducted a survey of ongoing clinical trials in RA registered in the ClinicalTrials.gov website. We used the advanced search option and applied the following inclusion criteria, "rheumatoid arthritis", "open studies", "interventional", and "adults 18 years or older". Of 127 eligible trials, 53.5% of the studies were either phase 3 or 4, and 40.2% were phase 1, 2, and 2/3. Two-thirds of the trials were randomized (70.9%), and over half were, in addition, double-blinded (53.5%) and placebo-controlled (53.5%). Universities were listed as the primary sponsor for 18.9% of the trials and pharmaceutical industry for 73.2%. Majority of the trials were multi-center studies (93%) conducted outside the United States (54.3%). The most frequently used endpoint was drug efficacy (54.3%) followed by drug safety (25.2%). Most industry-funded trials were open for less than 12 months, whereas most university-funded trials were open for more than 24 months (58% each). Biologic therapies were the focus of most trials in the registry (78.5%). Randomized, double-blinded, placebo-controlled, phase 3 and 4 trials form the majority of ongoing clinical trials in RA. The preponderance of industry funding of RA trials and the short duration of such trials are troubling trends which need to be addressed.

Correction to: Stimulation of intestinal calcium absorption by orally administrated vitamin D3 compounds: a prospective open-label randomized trial in osteoporosis.

PubMed

Uenishi, K; Tokiwa, M; Kato, S; Shiraki, M

2018-05-01

There were two errors in this article. 1. In the section "Ethical considerations", the registration number of the study was incorrectly given as UMIN000024492. The correct number is UMIN0000 20267. 2. The Acknowledgments paragraph was incomplete.

OxMaR: open source free software for online minimization and randomization for clinical trials.

PubMed

O'Callaghan, Christopher A

2014-01-01

Minimization is a valuable method for allocating participants between the control and experimental arms of clinical studies. The use of minimization reduces differences that might arise by chance between the study arms in the distribution of patient characteristics such as gender, ethnicity and age. However, unlike randomization, minimization requires real time assessment of each new participant with respect to the preceding distribution of relevant participant characteristics within the different arms of the study. For multi-site studies, this necessitates centralized computational analysis that is shared between all study locations. Unfortunately, there is no suitable freely available open source or free software that can be used for this purpose. OxMaR was developed to enable researchers in any location to use minimization for patient allocation and to access the minimization algorithm using any device that can connect to the internet such as a desktop computer, tablet or mobile phone. The software is complete in itself and requires no special packages or libraries to be installed. It is simple to set up and run over the internet using online facilities which are very low cost or even free to the user. Importantly, it provides real time information on allocation to the study lead or administrator and generates real time distributed backups with each allocation. OxMaR can readily be modified and customised and can also be used for standard randomization. It has been extensively tested and has been used successfully in a low budget multi-centre study. Hitherto, the logistical difficulties involved in minimization have precluded its use in many small studies and this software should allow more widespread use of minimization which should lead to studies with better matched control and experimental arms. OxMaR should be particularly valuable in low resource settings.

Open-field behavior of house mice selectively bred for high voluntary wheel-running.

PubMed

Bronikowski, A M; Carter, P A; Swallow, J G; Girard, I A; Rhodes, J S; Garland, T

2001-05-01

Open-field behavioral assays are commonly used to test both locomotor activity and emotionality in rodents. We performed open-field tests on house mice (Mus domesticus) from four replicate lines genetically selected for high voluntary wheel-running for 22 generations and from four replicate random-bred control lines. Individual mice were recorded by video camera for 3 min in a 1-m2 open-field arena on 2 consecutive days. Mice from selected lines showed no statistical differences from control mice with respect to distance traveled, defecation, time spent in the interior, or average distance from the center of the arena during the trial. Thus, we found little evidence that open-field behavior, as traditionally defined, is genetically correlated with wheel-running behavior. This result is a useful converse test of classical studies that report no increased wheel-running in mice selected for increased open-field activity. However, mice from selected lines turned less in their travel paths than did control-line mice, and females from selected lines had slower travel times (longer latencies) to reach the wall. We discuss these results in the context of the historical open-field test and newly defined measures of open-field activity.

Sensitivity and specificity of a new MRI method evaluating temporo-mandibular joint disc-condyle relationships: an in vivo study.

PubMed

Benbelaïd, R; Fleiter, B

2006-03-01

The aim of this study was to evaluate sensitivity and specificity of a new method to locate temporo-mandibular joint (TMJ) disc using magnetic resonance imaging (MRI) and analyze disc-condyle relationships, in asymptomatic subjects and patients with disc displacement. Twenty-nine sagittal MRI of 16 subjects, 8 asymptomatic volunteers and 8 subjects with anterior disc displacement, were carried out during controlled opening from intercuspal position up to a 25 mm opening. Selected sections were analyzed with a graphic computerized system of coordinates. The total surface area (TS) of disc section was separated into anterior surface area (AS) and posterior surface area. Areas were determined by computer. Two trained examiners drew images at random. The reliability of AS/TS ratio index was evaluated in a previous study. AS/TS ratio sensitivity (Se) and specificity (Sp) were calculated closed mouth, 5 mm open and 25 mm open mouth. Best sensitivity (Se=0.63) and specificity (Sp=0.81) were obtained when MRI was realized with closed mouth and 25 mm open mouth. Lower sensitivity was observed when MRI was performed either with closed mouth (Se=0.54) or 25 mm open mouth (Se=0.18). Lower specificity was observed with 5 mm open mouth (Sp=0.68). In conclusion, it was confirmed as well that MRI of anterior disc displacement should be performed with closed mouth and opened mouth. Thus, further studies are required to assess disc displacement and mechanical alterations and to evaluate the risk of direct damage on TMJ tissues.

The Miniaturization of the AFIT Random Noise Radar

DTIC Science & Technology

2013-03-01

RANDOM NOISE RADAR I. Introduction Recent advances in technology and signal processing techniques have opened thedoor to using an ultra-wide band random...AIR FORCE INSTITUTE OF TECHNOLOGY Wright-Patterson Air Force Base, Ohio DISTRIBUTION STATEMENT A. APPROVED FOR PUBLIC RELEASE; DISTRIBUTION UNLIMITED...and Computer Engineering Graduate School of Engineering and Management Air Force Institute of Technology Air University Air Education and Training

Antiviral therapy in hepatitis B virus-infected children with immune-tolerant characteristics: A pilot open-label randomized study.

PubMed

Zhu, Shishu; Zhang, Hongfei; Dong, Yi; Wang, Limin; Xu, Zhiqiang; Liu, Weiwei; Gan, Yu; Tang, Hongmei; Chen, Dawei; Wang, Fuchuan; Zhao, Pan

2018-06-01

Chronic infection with hepatitis B virus (HBV) in children is a serious health problem worldwide. How to treat children with immune-tolerant chronic hepatitis B infection, commonly characterized by hepatitis B e antigen (HBeAg) positivity, high viral load, normal or mildly elevated alanine aminotransferase and no or minimal inflammation in liver histology, remains unresolved. This trial aims to study the benefits of antiviral therapy in children with these characteristics. This is a pilot open-label randomized controlled study. From May 2014 to April 2015, 69 treatment-naive chronically HBV-infected children, aged 1 to 16 years, who had immune-tolerant characteristics were recruited to this trial and randomly assigned, in a 2:1 ratio, to treatment group and control group. Patients in the treatment group received either interferon-α (IFN) monotherapy or consecutively received IFN monotherapy, combination therapy of IFN and lamivudine (LAM), and LAM therapy alone. All patients were observed until week 96. At baseline, epidemiological, biochemical, serological, virological and histological indices were consistent across the treatment and control groups. Of the 46 patients in the treatment group, 73.91% had undetectable serum HBV DNA, 32.61% achieved HBeAg seroconversion and 21.74% lost hepatitis B surface antigen (HBsAg) at the endpoint. No LAM resistance emerged at week 96. In the control group, only one (4.35%) patient underwent spontaneous HBeAg seroconversion and had undetectable serum HBV DNA during observation, and moreover, none developed HBsAg clearance. For all patients, no serious adverse events were observed. Antiviral treatment with a sequential combination of IFN and LAM resulted in a significant improvement in the rates of undetectable serum HBV DNA, HBeAg seroconversion and HBsAg loss in children with chronic HBV infection and immune-tolerant characteristics. There is a lack of data regarding treatment of immune-tolerant chronic hepatitis B (CHB). It remains unresolved how children with immune-tolerant CHB should be treated. This paper reports the outcomes from a pilot open-label randomized controlled trial on antiviral therapy in children with immune-tolerant characteristics. It shows that a sequential combination of interferon-α and lamivudine was beneficial. Copyright © 2018 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Influence of Inter-Training Intervals on Intermanual Transfer Effects in Upper-Limb Prosthesis Training: A Randomized Pre-Posttest Study.

PubMed

Romkema, Sietske; Bongers, Raoul M; van der Sluis, Corry K

2015-01-01

Improvement in prosthetic training using intermanual transfer (the transfer of motor skills from the trained, “unaffected” hand to the untrained, “affected” hand) has been shown in previous studies. The aim of this study is to determine the influence of the inter-training interval on the magnitude of the intermanual transfer effects. This was done using a mechanistic, randomized, single-blinded pretest-posttest design. Sixty-four able-bodied, right-handed participants were randomly assigned to the Short and Long Interval Training Groups and the Short and Long Interval Control Groups. The Short and Long Interval Training Groups used a prosthesis simulator in their training program. The Short and Long Interval Control Groups executed a sham training program, that is, a dummy training program in which the same muscles were trained as with the prosthesis simulator. The Short Interval Training Group and the Short Interval Control Groups trained on consecutive days, while the Long Interval Training Group and Long Interval Control Group trained twice a week. To determine the improvement in skills, a test was administered before, immediately after, and at two points in time after the training. Training was performed with the “unaffected” arm; tests were performed with the “affected” arm. The outcome measurements were: the movement time (the time from the beginning of the movement until completion of the task); the duration of maximum hand opening, (the opening of the prosthetic hand while grasping an object); and the grip-force control (the error from the required grip-force during a tracking task). Intermanual transfer was found in movement times, but not in hand opening or grip-force control. The length of the inter-training interval did not affect the magnitude of intermanual transfer effects. No difference in the intermanual transfer effect in upper-limb prosthesis training was found for training on a daily basis as compared to training twice a week. Nederlands Trial Register NTR3888.

Influence of Inter-Training Intervals on Intermanual Transfer Effects in Upper-Limb Prosthesis Training: A Randomized Pre-Posttest Study

PubMed Central

Romkema, Sietske; Bongers, Raoul M.; van der Sluis, Corry K.

2015-01-01

Improvement in prosthetic training using intermanual transfer (the transfer of motor skills from the trained, “unaffected” hand to the untrained, “affected” hand) has been shown in previous studies. The aim of this study is to determine the influence of the inter-training interval on the magnitude of the intermanual transfer effects. This was done using a mechanistic, randomized, single-blinded pretest-posttest design. Sixty-four able-bodied, right-handed participants were randomly assigned to the Short and Long Interval Training Groups and the Short and Long Interval Control Groups. The Short and Long Interval Training Groups used a prosthesis simulator in their training program. The Short and Long Interval Control Groups executed a sham training program, that is, a dummy training program in which the same muscles were trained as with the prosthesis simulator. The Short Interval Training Group and the Short Interval Control Groups trained on consecutive days, while the Long Interval Training Group and Long Interval Control Group trained twice a week. To determine the improvement in skills, a test was administered before, immediately after, and at two points in time after the training. Training was performed with the “unaffected” arm; tests were performed with the “affected” arm. The outcome measurements were: the movement time (the time from the beginning of the movement until completion of the task); the duration of maximum hand opening, (the opening of the prosthetic hand while grasping an object); and the grip-force control (the error from the required grip-force during a tracking task). Intermanual transfer was found in movement times, but not in hand opening or grip-force control. The length of the inter-training interval did not affect the magnitude of intermanual transfer effects. No difference in the intermanual transfer effect in upper-limb prosthesis training was found for training on a daily basis as compared to training twice a week. Trial Registration Nederlands Trial Register NTR3888 PMID:26075396

Comparison of the latanoprost 0.005%/timolol 0.5% + brinzolamide 1% versus dorzolamide 1%/timolol 0.5% + latanoprost 0.005%: a 12-week, randomized open-label trial

PubMed Central

Nakakura, Shunsuke; Tabuchi, Hitoshi; Baba, Yukio; Maruiwa, Futoshi; Ando, Nobuko; Kanamoto, Takashi; Kiuchi, Yoshiaki

2012-01-01

Objective To compare the safety and effectiveness of fixed-combination regimes (latanoprost– timolol and brinzolamide 1% compared to dorzolamide 1%/timolol and latanoprost) in open-angle glaucoma patients after switching from a combination of three topical antiglaucoma eye drops. Methods We conducted an open, randomized 12-week multicenter prospective study. We randomly allocated 39 patients who had been treated with three antiglaucoma eye drops (prostaglandin F2α analogues plus beta-blockers and carbonic anhydrase inhibitors) into two groups. Group A (n = 20) were treated with latanoprost–timolol and brinzolamide 1% therapy and Group B (n = 16) were treated with dorzolamide 1%/timolol and latanoprost. Thirty-six patients completed all 12 weeks of this study. The major clinical parameters measured were intraocular pressure (IOP), conjunctive hyperemia, superficial punctate keratopathy and hyperpigmentation of eyelid at baseline, 4, and 12 weeks. Additionally noted were adverse events and patient preferences, measured using a questionnaire at study initiation and at 12 weeks. Results At baseline, IOPs were (Group A: 14.1 ± 2.9 mmHg, B: 14.5 ± 2.9 mmHg; P = 0.658), (Group A: 13.8 ± 2.6 mmHg, B: 14.3 ± 2.8 mmHg; P = 0.715) at 4 weeks, and (Group A: 14.1 ± 2.7 mmHg, B: 14.2 ± 2.7 mmHg; P = 0.538) at 12 weeks. Among the groups, there was no significant difference at any time point after baseline (P = 0.923, 0.951, respectively). All adverse events were not remarkably different after therapy. In regards to patient preference before and after switching therapy, 10 patients (50%) in Group A and 10 patients (63%) in Group B preferred using fixed-combination eye drop therapy. Conclusions Effectiveness and safety were maintained in both groups after switching therapy. Overall, patients generally preferred using a fixed-combination therapy. PMID:22419858

Open Versus Laparoscopic Approach for Morgagni's Hernia in Infants and Children: A Systematic Review and Meta-Analysis.

PubMed

Lauriti, Giuseppe; Zani-Ruttenstock, Elke; Catania, Vincenzo D; Antounians, Lina; Lelli Chiesa, Pierluigi; Pierro, Agostino; Zani, Augusto

2018-05-18

The laparoscopic repair of Morgagni's hernia (MH) has been reported to be safe and feasible. However, it is still unclear whether laparoscopy is superior to open surgery in repairing MH. Using a defined search strategy, three investigators independently identified all comparative studies reporting data on open and laparoscopic MH repair in patients <18 years of age. Case reports and opinion articles were excluded. Meta-analysis was conducted according to PRISMA guidelines and using RevMan 5.3. Data are expressed as mean ± SD. Systematic review - Of 774 titles/abstracts screened, 51 full-text articles were analyzed. Three studies were included (92 patients), with 53 (58%) open approaches and 39 (42%) laparoscopy. Meta-analysis - The length of surgery was shorter in laparoscopy (50.5 ± 17.0 min) than in open procedure (90.0 ± 15.0 min; P < .00001). Laparoscopy shortened the length of hospital stay (2.1 ± 1.4 days) versus open surgery (4.5 ± 2.1 days; P < .00001). There was no difference with regards to complications (laparoscopy: 8.8% ± 5.5%, open: 9.4% ± 1.6%; P = .087) and recurrences (laparoscopy: 2.9% ± 5.0%, open: 5.7% ± 1.8%; P = .84). Comparative studies indicate that laparoscopic MH repair can be performed in infants and children. Laparoscopy is associated with shortened length of surgery and hospital stay in comparison to open procedure. Prospective randomized studies would be needed to confirm present data.

Prolonged Follow-Up of Patients in the U.S. Multicenter Trial of Ursodeoxycholic Acid for Primary Biliary Cirrhosis

PubMed Central

Combes, Burton; Luketic, Velimir A.; Peters, Marion G.; Zetterman, Rowen K.; Garcia-Tsao, Guadalupe; Munoz, Santiago J.; Lin, Danyu; Flye, Nancy; Carithers, Robert L.

2013-01-01

OBJECTIVE Randomized, double-blind, placebo-controlled trials of ursodeoxycholic acid (UDCA) in patients with primary biliary cirrhosis (PBC) have not demonstrated improvement in survival during the placebo-controlled phases of these trials. Analyses purporting to demonstrate a survival advantage of UDCA are largely dependent on data obtained after the placebo phases were terminated, and placebo-treated patients were offered open-label UDCA. After completion of our 2-yr placebo-controlled trial of UDCA in which we observed no survival benefit for UDCA, we provided the patients with open-label UDCA to see if delay in providing UDCA for 2 yr had any effect on subsequent liver transplantation or death without liver transplantation. METHODS In our previously reported 2-yr placebo-controlled trial, 151 patients with PBC were randomized to receive either UDCA (n = 77) or placebo (n = 74). The number of patients who progressed to liver transplantation or death without transplantation were similar in both the groups, 12 (16%) in the UDCA-treated and 11 (15%) in placebo-treated patients. All the patients were then offered open-label UDCA, with 61 original UDCA and 56 original placebo-treated patients now taking UDCA in an extended open-label phase of the trial. RESULTS No significant differences were observed in the number of patients who underwent liver transplantation or died without liver transplantation in the open-label phase of the trial. Moreover, no difference in the time to these endpoints was seen over the period of observation of as long as 6 yr from the time of initial randomization. CONCLUSIONS Results of open-label extensions of previous conducted placebo-controlled trials of UDCA in PBC leave uncertain whether UDCA impacts significantly on liver transplantation and death without liver transplantation in patients with PBC. PMID:15046215

Long-Term Effectiveness and Safety of Dexmethylphenidate Extended-Release Capsules in Adult ADHD

ERIC Educational Resources Information Center

Adler, Lenard A.; Spencer, Thomas; McGough, James J.; Jiang, Hai; Muniz, Rafael

2009-01-01

Objective: This study evaluates dexmethylphenidate extended release (d-MPH-ER) in adults with ADHD. Method: Following a 5-week, randomized, controlled, fixed-dose study of d-MPH-ER 20 to 40 mg/d, 170 adults entered a 6-month open-label extension (OLE) to assess long-term safety, with flexible dosing of 20 to 40 mg/d. Exploratory effectiveness…

Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial.

PubMed

Dominguez-Rodriguez, Alberto; Burillo-Putze, Guillermo; Garcia-Saiz, Maria Del Mar; Aldea-Perona, Ana; Harmand, Magali González-Colaço; Mirò, Oscar; Abreu-Gonzalez, Pedro

2017-04-01

Morphine has been used for several decades in cases of acute pulmonary edema (APE) due to the anxiolytic and vasodilatory properties of the drug. The non-specific depression of the central nervous system is probably the most significant factor for the changes in hemodynamics in APE. Retrospective studies have shown both negative and neutral effects in patients with APE and therefore some authors have suggested benzodiazepines as an alternative treatment. The use of intravenous morphine in the treatment of APE remains controversial. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE. The MIMO trial will evaluate as a primary endpoint whether intravenous morphine administration improves clinical outcomes defined as in-hospital mortality. Secondary endpoint evaluation will be mechanical ventilation, cardiopulmonary resuscitation, intensive care unit admission rate, intensive care unit length of stay, and hospitalization length. In the emergency department, morphine is still used for APE in spite of poor scientific background data. The data from the MIMO trial will establish the effect-and especially the risk-when using morphine for APE.

Opening the pleura during internal mammary artery harvesting: advantages and disadvantages

PubMed Central

Ali, Idris M.; Lau, Peter; Kinley, C. Edwin; Sanalla, Abulkasim

1996-01-01

Objective To evaluate the findings of previous studies that opening of the pleura during internal mammary artery (IMA) dissection might be an important factor in increasing the operative morbidity. Design A randomized control trial. Setting A university hospital. Patients Two hundred and eighty consecutive patients with no significant pulmonary disease. Intervention Harvesting of the IMA with (130 patients) or without (150 patients) opening the pleura. Main Outcome Measures Comparison of the incidence of pleural effusion, cardiac tamponade, postoperative respiratory complications and the hospital stay. Results Pleural effusion occurred more often in the patients who had opening of the pleura (20% versus 5%); however, none of the patients required tapping. Postoperative bleeding with cardiac tamponade occurred in five patients in the closed pleura group. Six patients in the open pleura group had postoperative bleeding but without tamponade. The average postoperative hospital stay was 7 days for both groups. No significant differences were recorded in postoperative respiratory complications. Conclusions Opening of the pleura during IMA harvesting does not increase the operative morbidity. It may have other advantages and is recommended in most cases of IMA harvesting. PMID:8599790

Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

PubMed Central

2011-01-01

Background Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. Methods The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. Conclusions The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547 PMID:22111914

Multimedia educational tools for cognitive surgical skill acquisition in open and laparoscopic colorectal surgery: a randomized controlled trial.

PubMed

Shariff, U; Kullar, N; Haray, P N; Dorudi, S; Balasubramanian, S P

2015-05-01

Conventional teaching in surgical training programmes is constrained by time and cost, and has room for improvement. This study aimed to determine the effectiveness of a multimedia educational tool developed for an index colorectal surgical procedure (anterior resection) in teaching and assessment of cognitive skills and to evaluate its acceptability amongst general surgical trainees. Multimedia educational tools in open and laparoscopic anterior resection were developed by filming multiple operations which were edited into procedural steps and substeps and then integrated onto interactive navigational platforms using Adobe® Flash® Professional CS5 10.1. A randomized controlled trial was conducted on general surgical trainees to evaluate the effectiveness of online multimedia in comparison with conventional 'study day' teaching for the acquisition of cognitive skills. All trainees were assessed before and after the study period. Trainees in the multimedia group evaluated the tools by completing a survey. Fifty-nine trainees were randomized but 27% dropped out, leaving 43 trainees randomized to the multimedia group (n = 25) and study day group (n = 18) who were available for analysis. Posttest scores improved significantly in both groups (P < 0.01). The change in scores (mean ± SD) in the multimedia group was not significantly different from the study day group (6.02 ± 5.12 and 5.31 ± 3.42, respectively; P = 0.61). Twenty-five trainees completed the evaluation survey and experienced an improvement in their decision making (67%) and in factual and anatomical knowledge (88%); 96% agreed that the multimedia tool was a useful additional educational resource. Multimedia tools are effective for the acquisition of cognitive skills in colorectal surgery and are well accepted as an educational resource. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

Randomized, double-blind trial of simultaneous right and left atrial epicardial pacing for prevention of post-open heart surgery atrial fibrillation.

PubMed

Daoud, E G; Dabir, R; Archambeau, M; Morady, F; Strickberger, S A

2000-08-15

The purpose of this study was to assess simultaneous right and left atrial pacing as prophylaxis for postoperative atrial fibrillation. In a double-blind, randomized fashion, 118 patients who underwent open heart surgery were assigned to right atrial pacing at 45 bpm (RA-AAI; n=39), right atrial triggered pacing at a rate of >/=85 bpm (RA-AAT; n=38), or simultaneous right and left atrial triggered pacing at a rate of >/=85 bpm (Bi-AAT; n=41). Holter monitoring was performed for 4. 8+/-1.4 days after surgery to assess for episodes of atrial fibrillation lasting >5 minutes. The prevalence of postoperative atrial fibrillation was significantly less in the patients randomized to biatrial AAT pacing when compared with the other 2 pacing regimens (P=0.02). An episode of atrial fibrillation occurred in 4 (10%) of 41 patients in the Bi-AAT group compared with 11 (28%) of 39 patients in the RA-AAI group (P=0.03 versus Bi-AAT) and 12 (32%) of 38 patients in the RA-AAT group (P=0.01 versus Bi-AAT). There was no difference in the occurrence of atrial fibrillation between the right atrial AAI and AAT groups (P=0.8). There was no significant difference among the 3 groups with regard to the number of postoperative hospital days (7.3+/-4.2 days), morbidity (5.1%), or mortality rate (2.5%). Simultaneous right and left atrial triggered pacing is well tolerated and significantly reduces the prevalence of post-open heart surgery atrial fibrillation.

Possible combinations of electronic data capture and randomization systems. principles and the realization with RANDI2 and OpenClinica.

PubMed

Schrimpf, D; Haag, M; Pilz, L R

2014-01-01

Clinical trials (CT) are in a wider sense experiments to prove and establish clinical benefit of treatments. Nowadays electronic data capture systems (EDCS) are used more often bringing a better data management and higher data quality into clinical practice. Also electronic systems for the randomization are used to assign the patients to the treatments. If the mentioned randomization system (RS) and EDCS are used, possibly identical data are collected in both, especially by stratified randomization. This separated data storage may lead to data inconsistency and in general data samples have to be aligned. The article discusses solutions to combine RS and EDCS. In detail one approach is realized and introduced. Different possible settings of combination of EDCS and RS are determined and the pros and cons for each solution are worked out. For the combination of two independent applications the necessary interfaces for the communication are defined. Thereby, existing standards are considered. An example realization is implemented with the help of open-source applications and state-of-the-art software development procedures. Three possibilities of separate usage or combination of EDCS and RS are presented and assessed: i) the complete independent usage of both systems; ii) realization of one system with both functions; and iii) two separate systems, which communicate via defined interfaces. In addition a realization of our preferred approach, the combination of both systems, is introduced using the open source tools RANDI2 and OpenClinica. The advantage of a flexible independent development of EDCS and RS is shown based on the fact that these tool are very different featured. In our opinion the combination of both systems via defined interfaces fulfills the requirements of randomization and electronic data capture and is feasible in practice. In addition, the use of such a setting can reduce the training costs and the error-prone duplicated data entry.

Effect of Aromatherapy Massage on Chemotherapy-Induced Peripheral Neuropathic Pain and Fatigue in Patients Receiving Oxaliplatin: An Open Label Quasi-Randomized Controlled Pilot Study.

PubMed

Izgu, Nur; Ozdemir, Leyla; Bugdayci Basal, Fatma

2017-12-02

Patients receiving oxaliplatin may experience peripheral neuropathic pain and fatigue. Aromatherapy massage, a nonpharmacological method, may help to control these symptoms. The aim of this open-label, parallel-group, quasi-randomized controlled pilot study was to investigate the effect of aromatherapy massage on chemotherapy-induced peripheral neuropathic pain and fatigue in patients receiving oxaliplatin. Stratified randomization was used to allocate 46 patients to 2 groups: intervention (n = 22) and control (n = 24). Between week 1 and week 6, participants in the intervention group (IG) received aromatherapy massage 3 times a week. There was no intervention in weeks 7 and 8. The control group (CG) received routine care. Neuropathic pain was identified using the Douleur Neuropathique 4 Questions; severity of painful paresthesia was assessed with the numerical rating scale; fatigue severity was identified with the Piper Fatigue Scale. At week 6, the rate of neuropathic pain was significantly lower in the IG, when compared with the CG. The severity of painful paresthesia based on numerical rating scale in the IG was significantly lower than that in the CG at weeks 2, 4, and 6. At week 8, fatigue severity in the IG was significantly lower when compared with CG (P < .05). Aromatherapy massage may be useful in the management of chemotherapy-induced peripheral neuropathic pain and fatigue. This pilot study suggests that aromatherapy massage may be useful to relieve neuropathic pain and fatigue. However, there is a need for further clinical trials to validate the results of this study.

Levetiracetam versus lorazepam in status epilepticus: a randomized, open labeled pilot study.

PubMed

Misra, U K; Kalita, J; Maurya, P K

2012-04-01

For the management of status epilepticus (SE), lorazepam (LOR) is recommended as the first and phenytoin or fosphenytoin as the second choice. Both these drugs have significant toxicity. Intravenous levetiracetam (LEV) has become available, but its efficacy and safety has not been reported in comparison to LOR. We report a randomized, open labeled pilot study comparing the efficacy and safety of LEV and LOR in SE. Consecutive patients with convulsive or subtle convulsive SE were randomized to LEV 20 mg/kg IV over 15 min or LOR 0.1 mg/kg over 2-4 min. Failure to control SE within 10 min of administration of one study drug was treated by the other study drug. The primary endpoint was clinical seizure cessation and secondary endpoints were 24 h freedom from seizure, hospital mortality, and adverse events. Our results are based on 79 patients. Both LEV and LOR were equally effective. In the first instance, the SE was controlled by LEV in 76.3% (29/38) and by LOR in 75.6% (31/41) of patients. In those resistant to the above regimen, LEV controlled SE in 70.0% (7/10) and LOR in 88.9% (8/9) patients. The 24-h freedom from seizure was also comparable: by LEV in 79.3% (23/29) and LOR in 67.7% (21/31). LOR was associated with significantly higher need of artificial ventilation and insignificantly higher frequency of hypotension. For the treatment of SE, LEV is an alternative to LOR and may be preferred in patients with respiratory compromise and hypotension.

Pushing the glass transition towards random close packing using self-propelled hard spheres

NASA Astrophysics Data System (ADS)

Ni, Ran; Stuart, Martien A. Cohen; Dijkstra, Marjolein

2013-10-01

Although the concept of random close packing with an almost universal packing fraction of approximately 0.64 for hard spheres was introduced more than half a century ago, there are still ongoing debates. The main difficulty in searching the densest packing is that states with packing fractions beyond the glass transition at approximately 0.58 are inherently non-equilibrium systems, where the dynamics slows down with a structural relaxation time diverging with density; hence, the random close packing is inaccessible. Here we perform simulations of self-propelled hard spheres, and we find that with increasing activity the relaxation dynamics can be sped up by orders of magnitude. The glass transition shifts to higher packing fractions upon increasing the activity, allowing the study of sphere packings with fluid-like dynamics at packing fractions close to RCP. Our study opens new possibilities of investigating dense packings and the glass transition in systems of hard particles.

Science Teacher Training Programme in Rural Schools: An ODL Lesson from Zimbabwe

ERIC Educational Resources Information Center

Mhishi, Misheck; Bhukuvhani, Crispen Erinos; Sana, Abel Farikai

2012-01-01

This case study looked at 76 randomly selected preservice science teachers from Mbire and Guruve districts who were learning at the Mushumbi Centre in Zimbabwe and assessed their motivations for enrolling under the Bindura University of Science Education (BUSE)'s Virtual and Open Distance Learning (VODL) programme. It also looked at the challenges…

Evaluation of the effectiveness of a semi-finished occlusal appliance – a randomized, controlled clinical trial

PubMed Central

2013-01-01

Introduction Painful temporomandibular disorders (TMDs) are usually treated with physiotherapy, self-exercises, medication-based therapy and splint therapy. For splint therapy different types of splints are available. Therefore this randomized controlled study compared the effectiveness of a semi-finished occlusal appliance (SB) with a laboratory-made occlusal appliance (SS) in myofascial pain patients. Method The trial subjects allocated to the experimental groups with the (SB) occlusal appliance and those provided with a laboratory-made occlusal appliance (SS) did, in addition, receive conservative treatment (self-exercises, drug-based and manual therapy). The control group was given conservative therapy (CO) only. Overall, a total of 63 patients participated in the study with each group consisting of 21 subjects. Results When the first follow-up examination took place (14 days after splint insertion) mouth opening within the SB group was significantly enlarged. When the second examination was conducted (2.5 months after splint insertion) mouth opening was significantly enlarged in both splint groups when compared with the initial value. In the control group, no significant enlargement of mouth opening was detected. At no point there was a significant reduction in the number of pressure-sensitive areas of the TMJ. On palpation of the masticatory muscles however, a significant reduction in the number of pressure-sensitive areas could be observed within the CO group and the SS group after 2.5 months. When comparing pain reduction (muscle/joint pain) and mouth opening, no significant differences could be detected between the treatments. Conclusion The results suggest that TMD should be treated conservatively. In cases of restricted mouth opening, the additional use of occlusal appliances can eliminate the patient’s discomfort more quickly. In this context, the tested, semi-finished occlusal appliance appears to offer an immediately available, temporary alternative to laboratory-made splints. PMID:23351923

Behavioral Reactivity Associated With Electronic Monitoring of Environmental Health Interventions--A Cluster Randomized Trial with Water Filters and Cookstoves.

PubMed

Thomas, Evan A; Tellez-Sanchez, Sarita; Wick, Carson; Kirby, Miles; Zambrano, Laura; Abadie Rosa, Ghislaine; Clasen, Thomas F; Nagel, Corey

2016-04-05

Subject reactivity--when research participants change their behavior in response to being observed--has been documented showing the effect of human observers. Electronics sensors are increasingly used to monitor environmental health interventions, but the effect of sensors on behavior has not been assessed. We conducted a cluster randomized controlled trial in Rwanda among 170 households (70 blinded to the presence of the sensor, 100 open) testing whether awareness of an electronic monitor would result in a difference in weekly use of household water filters and improved cookstoves over a four-week surveillance period. A 63% increase in number of uses of the water filter per week between the groups was observed in week 1, an average of 4.4 times in the open group and 2.83 times in the blind group, declining in week 4 to an insignificant 55% difference of 2.82 uses in the open, and 1.93 in the blind. There were no significant differences in the number of stove uses per week between the two groups. For both filters and stoves, use decreased in both groups over four-week installation periods. This study suggests behavioral monitoring should attempt to account for reactivity to awareness of electronic monitors that persists for weeks or more.

Effects of Vestibular Rehabilitation on Balance Control in Older People with Chronic Dizziness: A Randomized Clinical Trial.

PubMed

Ricci, Natalia Aquaroni; Aratani, Mayra Cristina; Caovilla, Heloísa Helena; Ganança, Fernando Freitas

2016-04-01

The aim of this study was to compare the effects of vestibular rehabilitation protocols on balance control in elderly with dizziness. This is a randomized clinical trial with 3-mo follow-up period. The sample was composed of 82 older individuals with chronic dizziness from vestibular disorders. The control group was treated according to the Conventional Cawthorne & Cooksey protocol (n = 40), and the experimental group was submitted to a Multimodal Cawthorne & Cooksey protocol (n = 42). Measures included Dynamic Gait Index, fall history, hand grip strength, Time Up-and-Go Test, sit-to-stand test, multidirectional reach, and static balance tests. With the exception of history of falls, Forward Functional Reach, Unipedal Right and Left Leg Eyes Closed, and Sensorial Romberg Eyes Open, all outcomes improved after treatments. Such results persisted at follow-up period, with the exception of the Tandem Eyes Open and the Timed Up-and-Go manual. The between-group differences for Sensorial Romberg Eyes Closed (4.27 secs) and Unipedal Left Leg Eyes Open (4.08 secs) were significant after treatment, favoring the Multimodal protocol. Both protocols resulted in improvement on elderly's balance control, which was maintained during a short-term period. The multimodal protocol presented better performance on specific static balance tests.

Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial.

PubMed

Han, Ji Won; Son, Kyung Lak; Byun, Hye Jin; Ko, Ji Won; Kim, Kayoung; Hong, Jong Woo; Kim, Tae Hyun; Kim, Ki Woong

2017-06-06

Spaced retrieval training (SRT) is a nonpharmacological intervention for mild cognitive impairment (MCI) and dementia that trains the learning and retention of target information by recalling it over increasingly long intervals. We recently developed the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program as a convenient, self-administered tablet-based SRT program. We also demonstrated the utility of USMART for improving memory in individuals with MCI through an open-label uncontrolled trial. This study had an open-label, single-blind, randomized, controlled, two-period crossover design. Fifty patients with MCI were randomized into USMART-usual care and usual care-USMART treatment sequences. USMART was completed or usual care was provided biweekly over a 4-week treatment period with a 2-week washout period between treatment periods. Primary outcome measures included the Word List Memory Test, Word List Recall Test (WLRT), and Word List Recognition Test. Outcomes were measured at baseline, week 5, and week 11 by raters who were blinded to intervention type. An intention-to-treat analysis and linear mixed modeling were used. Of 50 randomized participants, 41 completed the study (18% dropout rate). The USMART group had larger improvements in WLRT score (effect size = 0.49, p = 0.031) than the usual care group. There were no significant differences in other primary or secondary measures between the USMART and usual care groups. Moreover, no USMART-related adverse events were reported. The 4-week USMART modestly improved information retrieval in older people with MCI, and was well accepted with minimal technical support. ClinicalTrials.gov NCT01688128 . Registered 12 September 2012.

Phase 2a, Open-Label, 4-Escalating-Dose, Randomized Multicenter Study Evaluating the Safety and Activity of Ferroquine (SSR97193) Plus Artesunate, versus Amodiaquine Plus Artesunate, in African Adult Men with Uncomplicated Plasmodium falciparum Malaria.

PubMed

Supan, Christian; Mombo-Ngoma, Ghyslain; Kombila, Maryvonne; Ospina Salazar, Carmen L; Held, Jana; Lell, Bertrand; Cantalloube, Cathy; Djeriou, Elhadj; Ogutu, Bernhards; Waitumbi, John; Otsula, Nekoye; Apollo, Duncan; Polhemus, Mark E; Kremsner, Peter G; Walsh, Douglas S

2017-08-01

Artemisinin-based combination therapies are recommended as first-line agents for treating uncomplicated Plasmodium falciparum malaria. Ferroquine, a 4-aminoquinolone, is a novel long-acting combination partner for fast-acting drugs like artesunate (AS). We did a small phase 2a, multicenter, open-label, safety-focused dose-ranging randomized study of ferroquine at three African hospitals: two Gabonese and one Kenyan. We recruited adult men with symptomatic uncomplicated P. falciparum monoinfection. Four escalating doses of ferroquine (100, 200, 400, and 600 mg) were assessed in sequence, versus an amodiaquine comparator. After a 2:1 randomization (block size three, equating to N = 12 for each ferroquine dose and N = 6 for each of four amodiaquine comparator groups) patients received daily for three consecutive days, either ferroquine + AS (200 mg/day) or amodiaquine (612 mg/day) + AS (200 mg/day). Safety, electrocardiograms, parasite clearance times, efficacy, and pharmacokinetics were assessed to day 28. Seventy-two patients were randomized. Ferroquine + AS showed generally mild increases (Grade 1 toxicity) in alanine aminotransferase (ALT) levels with a dose trend starting at 400 mg. There were two Grade 2 ALT events: one patient receiving 200 mg (3.8 upper limit of normal [ULN], day 7) and one receiving 600 mg (3.3 ULN, day 14), both without increased bilirubin. One ferroquine 100 mg + AS patient after one dose was withdrawn after developing a QTcF interval prolongation > 60 milliseconds over baseline. Parasitemias in all patients cleared quickly, with no recurrence through day 28. Hepatic, as well as cardiac, profiles should be monitored closely in future trials. (ClinicalTrials.gov: NCT00563914).

Efficacy and safety of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus uncontrolled on metformin monotherapy: Results of a Phase IV open-label randomized controlled study (the SMART study).

PubMed

Du, Jin; Liang, Li; Fang, Hui; Xu, Fengmei; Li, Wei; Shen, Liya; Wang, Xueying; Xu, Chun; Bian, Fang; Mu, Yiming

2017-11-01

To investigate the efficacy, safety and tolerability of saxagliptin compared with acarbose in Chinese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. SMART was a 24-week, multicentre, randomized, parallel-group, open-label Phase IV study conducted at 35 sites in China (September 24, 2014 to September 29, 2015). The primary outcome was absolute change from baseline in HbA1c at Week 24. Secondary outcomes assessed at Week 24 included the proportion of patients achieving HbA1c < 7.0%, the proportion of patients with gastrointestinal adverse events (GI AEs), and the proportion of patients achieving HbA1c < 7.0% without GI AEs. Safety and tolerability were also assessed in all patients who received ≥1 dose of study medication. Four-hundred and eighty-eight patients were randomized (1:1) to saxagliptin or acarbose via a central randomization system (interactive voice/web response system); 241 and 244 patients received saxagliptin and acarbose, respectively, and 238 and 243 of these had ≥1 pre- and ≥1 post-baseline efficacy values recorded. Saxagliptin was non-inferior to acarbose for glycaemic control [Week 24 HbA1c change: -0.82% and -0.78%, respectively; difference (95% confidence interval): -0.04 (-0.22, 0.13)%], with similar proportions of patients in both treatment groups achieving HbA1c < 7.0%. However, fewer GI AEs were reported with saxagliptin compared with acarbose, and a greater number of patients who received saxagliptin achieved HbA1c < 7.0% without GI AEs compared with those receiving acarbose. Both therapies had similar efficacy profiles. However, saxagliptin was associated with fewer GI AEs, suggesting it might be preferential for clinical practice. NCT02243176, clinicaltrials.gov. © 2017 John Wiley & Sons Ltd.

A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy.

PubMed

Rex, Douglas K; Bhandari, Raj; Desta, Taddese; DeMicco, Michael; Schaeffer, Cynthia; Etzkorn, Kyle; Barish, Charles; Pruitt, Ronald; Cash, Brooks D; Quirk, Daniel; Tiongco, Felix; Sullivan, Shelby; Bernstein, David

2018-04-30

Remimazolam is an ultrashort-acting benzodiazepine. We performed a randomized double-blind comparison of remimazolam to placebo for outpatient colonoscopy. This study design was a requirement of the U.S. Food and Drug Administration. An additional group was randomized to open-label midazolam administered according to its package insert instructions (randomization ratio for remimazolam:placebo:midazolam was 30:6:10). Study medications were administered under the supervision of the endoscopist, without any involvement of an anesthesia specialist. Patients were given 50 to 75 μg of fentanyl before receiving study medications. Patients who failed to achieve adequate sedation in any arm were rescued with midazolam dosed at the investigator's discretion. The primary endpoint was a composite that required 3 criteria be met: completion of the colonoscopy, no need for rescue medication, and ≤5 doses of remimazolam or placebo in any 15-minute interval (≤3 doses of midazolam in any 12-minute interval in the open-label midazolam arm). There were 461 randomized patients in 12 U.S. sites. The primary endpoint was met for remimazolam, placebo, and midazolam in 91.3%, 1.7%, and 25.2% of patients, respectively (P< 0.0001 for remimazolam vs placebo). Patients administered remimazolam received less fentanyl, had faster recovery of neuropsychiatric function, were ready for discharge faster, and felt back to normal faster than patients with both placebo and midazolam. Hypotension was less frequent with remimazolam and hypoxia occurred in 1% of subjects with remimazolam or midazolam. There were no treatment-emergent serious adverse events. Remimazolam can be safely administered under the supervision of endoscopists for outpatient colonoscopy and allows faster recovery of neuropsychiatric function compared with placebo (midazolam rescue) and midazolam. Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

The influence of food abundance, food dispersion and habitat structure on territory selection and size of an Afrotropical terrestrial insectivore

USGS Publications Warehouse

Stanley, Thomas R.; Newmark, William D.

2015-01-01

Most tropical insectivorous birds, unlike their temperate counterparts, hold and defend a feeding and breeding territory year-around. However, our understanding of ecological factors influencing territory selection and size in tropical insectivores is limited. Here we examine three prominent hypotheses relating food abundance, food dispersion (spatial arrangement of food items), and habitat structure to territoriality in the Usambara Thrush Turdus roehli. We first compared leaf-litter macro-invertebrate abundance and dispersion, and habitat structure between territories and random sites. We then examined the relation between these same ecological factors and territory size. Invertebrate abundance and dispersion were sparsely and evenly distributed across our study system and did not vary between territories and random sites. In contrast, habitat structure did vary between territories and random sites indicating the Usambara Thrush selects territories with open understorey and closed overstorey habitat. Invertebrate abundance and dispersion within territories of the Usambara Thrush were not associated with habitat structure. We believe the most likely explanation for the Usambara Thrush’s preference for open understorey and closed overstorey habitat relates to foraging behavior. Using information-theoretic model selection we found that invertebrate abundance was the highest-ranked predictor of territory size and was inversely related, consistent with food value theory of territoriality.

Random Fill Cache Architecture (Preprint)

DTIC Science & Technology

2014-10-01

a concrete example, we show how the cache collision attack works to extract the AES encryption keys (e.g., in the OpenSSL implementation of AES). AES...each round are implemented as table lookups for performance reasons. OpenSSL uses ten 1-KB lookup tables, five for encryption and five for decryption

Open source posturography.

PubMed

Rey-Martinez, Jorge; Pérez-Fernández, Nicolás

2016-12-01

The proposed validation goal of 0.9 in intra-class correlation coefficient was reached with the results of this study. With the obtained results we consider that the developed software (RombergLab) is a validated balance assessment software. The reliability of this software is dependent of the used force platform technical specifications. Develop and validate a posturography software and share its source code in open source terms. Prospective non-randomized validation study: 20 consecutive adults underwent two balance assessment tests, six condition posturography was performed using a clinical approved software and force platform and the same conditions were measured using the new developed open source software using a low cost force platform. Intra-class correlation index of the sway area obtained from the center of pressure variations in both devices for the six conditions was the main variable used for validation. Excellent concordance between RombergLab and clinical approved force platform was obtained (intra-class correlation coefficient =0.94). A Bland and Altman graphic concordance plot was also obtained. The source code used to develop RombergLab was published in open source terms.

Opening toward life: experiences of basic body awareness therapy in persons with major depression.

PubMed

Danielsson, Louise; Rosberg, Susanne

2015-01-01

Although there is a vast amount of research on different strategies to alleviate depression, knowledge of movement-based treatments focusing on body awareness is sparse. This study explores the experiences of basic body awareness therapy (BBAT) in 15 persons diagnosed with major depression who participated in the treatment in a randomized clinical trial. Hermeneutic phenomenological methodology inspired the approach to interviews and data analysis. The participants' experiences were essentially grasped as a process of enhanced existential openness, opening toward life, exceeding the tangible corporeal dimension to also involve emotional, temporal, and relational aspects of life. Five constituents of this meaning were described: vitality springing forth, grounding oneself, recognizing patterns in one's body, being acknowledged and allowed to be oneself, and grasping the vagueness. The process of enhanced perceptual openness challenges the numbness experienced in depression, which can provide hope for change, but it is connected to hard work and can be emotionally difficult to bear. Inspired by a phenomenological framework, the results of this study illuminate novel clinical and theoretical insight into the meaning of BBAT as an adjunctive approach in the treatment of depression.

Renal access in PNL under sonographic guidance: Do we really need to insert an open end ureteral catheter in dilated renal systems? A prospective randomized study.

PubMed

Eryildirim, Bilal; Tuncer, Murat; Camur, Emre; Ustun, Fatih; Tarhan, Fatih; Sarica, Kemal

2017-10-03

To evaluate the true necessity of open end ureteral catheter insertion in patients with moderate to severe pelvicalyceal system dilation treated with percutaneous nephrolithotomy (PNL) under sonographic guidance. 50 cases treated with PNL under sonographic guidance in prone position for solitary obstructing renal stones were evaluated. Patients were randomly divided into two groups; Group 1: Patients in whom a open end ureteral catheter was inserted prior to the procedure; Group 2: Patients receiving no catheter before PNL. In addition to the duration of the procedure as a whole and also all relevant stages as well, radiation exposure time, hospitalization period, mean nephrostomy tube duration, mean drop in Hb levels and all intra and postoperative complications have been evaluated. Mean size of the stones was 308.5 ± 133.2 mm2. Mean total duration of the PNL procedure in cases with open end ureteral catheter was significantly longer than the other cases (p < 0.001). Evaluation of the outcomes of the PNL procedures revealed no statistically significant difference between two groups regarding the stone-free rates (86% vs 84%). Additionally, there was no significant difference with respect to the duration of nephrostomy tube, hospitalization period and secondary procedures needed, complication rates as well as the post-operative Hb drop levels in both groups (p = 0.6830). Our results indicate that the placement of an open end ureteral catheter prior to a PNL procedure performed under sonographic access may not be indicated in selected cases presenting with solitary obstructing renal pelvic and/or calyceal stones.

A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment.

PubMed

Rauck, Richard L; Hale, Martin E; Bass, Almasa; Bramson, Candace; Pixton, Glenn; Wilson, Jacquelyn G; Setnik, Beatrice; Meisner, Paul; Sommerville, Kenneth W; Malhotra, Bimal K; Wolfram, Gernot

2015-09-01

The objective of this multicenter, double-blind, placebo-controlled, randomized withdrawal study was to evaluate the efficacy and safety of ALO-02, an abuse-deterrent formulation containing pellets of extended-release oxycodone hydrochloride (HCl) surrounding sequestered naltrexone HCl, compared with placebo in the treatment of moderate-to-severe chronic low back pain. An open-label titration period in which all patients received ALO-02 was followed by a double-blind treatment period where patients meeting treatment response criteria were randomized to either a fixed dose of ALO-02 or placebo. Daily average low back pain was assessed using an 11-point numeric rating scale (NRS)-Pain. Of the 663 patients screened, 410 received ALO-02 during the open-label conversion and titration period and 281 patients were randomized to the double-blind treatment period (n = 134, placebo; n = 147, ALO-02). Change in the mean NRS-Pain score from randomization baseline to the final 2 weeks of the treatment period was significantly different favoring ALO-02 compared with placebo (P = 0.0114). Forty-four percent of patients treated with placebo and 57.5% of patients treated with ALO-02 reported ≥30% improvement in weekly average NRS-Pain scores from screening to the final 2 weeks of the treatment period (P = 0.0248). In the double-blind treatment period, 56.8% of patients in the ALO-02 group and 56.0% of patients in the placebo group experienced a treatment-emergent adverse event (TEAE). The most common treatment-related TEAEs for ALO-02 during the treatment period were nausea, vomiting, and constipation, consistent with opioid therapy. ALO-02 has been demonstrated to provide significant reduction of pain in patients with chronic low back pain and has a safety profile similar to other opioids.

Rationale, Design, and Baseline Characteristics of the Utopia Trial for Preventing Diabetic Atherosclerosis Using an SGLT2 Inhibitor: A Prospective, Randomized, Open-Label, Parallel-Group Comparative Study.

PubMed

Katakami, Naoto; Mita, Tomoya; Yoshii, Hidenori; Shiraiwa, Toshihiko; Yasuda, Tetsuyuki; Okada, Yosuke; Umayahara, Yutaka; Kaneto, Hideaki; Osonoi, Takeshi; Yamamoto, Tsunehiko; Kuribayashi, Nobuichi; Maeda, Kazuhisa; Yokoyama, Hiroki; Kosugi, Keisuke; Ohtoshi, Kentaro; Hayashi, Isao; Sumitani, Satoru; Tsugawa, Mamiko; Ohashi, Makoto; Taki, Hideki; Nakamura, Tadashi; Kawashima, Satoshi; Sato, Yasunori; Watada, Hirotaka; Shimomura, Iichiro

2017-10-01

Sodium-glucose co-transporter-2 (SGLT2) inhibitors are anti-diabetic agents that improve glycemic control with a low risk of hypoglycemia and ameliorate a variety of cardiovascular risk factors. The aim of the ongoing study described herein is to investigate the preventive effects of tofogliflozin, a potent and selective SGLT2 inhibitor, on the progression of atherosclerosis in subjects with type 2 diabetes (T2DM) using carotid intima-media thickness (IMT), an established marker of cardiovascular disease (CVD), as a marker. The Study of Using Tofogliflozin for Possible better Intervention against Atherosclerosis for type 2 diabetes patients (UTOPIA) trial is a prospective, randomized, open-label, blinded-endpoint, multicenter, and parallel-group comparative study. The aim was to recruit a total of 340 subjects with T2DM but no history of apparent CVD at 24 clinical sites and randomly allocate these to a tofogliflozin treatment group or a conventional treatment group using drugs other than SGLT2 inhibitors. As primary outcomes, changes in mean and maximum IMT of the common carotid artery during a 104-week treatment period will be measured by carotid echography. Secondary outcomes include changes in glycemic control, parameters related to β-cell function and diabetic nephropathy, the occurrence of CVD and adverse events, and biochemical measurements reflecting vascular function. This is the first study to address the effects of SGLT2 inhibitors on the progression of carotid IMT in subjects with T2DM without a history of CVD. The results will be available in the very near future, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent CVD. Kowa Co., Ltd. UMIN000017607.

Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study.

PubMed

Papp, Kim A; Krueger, James G; Feldman, Steven R; Langley, Richard G; Thaci, Diamant; Torii, Hideshi; Tyring, Stephen; Wolk, Robert; Gardner, Annie; Mebus, Charles; Tan, Huaming; Luo, Yingchun; Gupta, Pankaj; Mallbris, Lotus; Tatulych, Svitlana

2016-05-01

Tofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. We sought to report longer-term tofacitinib efficacy and safety in patients with moderate to severe psoriasis. Data from 2 identical phase-III studies, Oral-treatment Psoriasis Trial Pivotal 1 and 2, were pooled with data from these patients in an ongoing open-label long-term extension study. Patients (n = 1861) were randomized 2:2:1 to tofacitinib 5 mg, 10 mg, or placebo twice daily (BID). At week 16, placebo patients were rerandomized to tofacitinib. Pivotal study participants could enroll into the long-term extension where they received tofacitinib at 10 mg BID for 3 months, after which dosing could be 5 or 10 mg BID. At week 28, the proportions of patients randomized to tofacitinib 5 and 10 mg BID achieving 75% or greater reduction in Psoriasis Area and Severity Index score from baseline were 55.6% and 68.8%, and achieving Physician Global Assessment of clear or almost clear were 54.7% and 65.9%. Efficacy was maintained in most patients through 24 months. Serious adverse events and discontinuations because of adverse events were reported in less than 11% of patients over 33 months of tofacitinib exposure. There was no dose comparison beyond week 52. Oral tofacitinib demonstrated sustained efficacy in patients with psoriasis through 2 years, with 10 mg BID providing greater efficacy than 5 mg BID. No unexpected safety findings were observed. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Effects on agitation with rivastigmine patch monotherapy and combination therapy with memantine in mild to moderate Alzheimer's disease: a multicenter 24-week prospective randomized open-label study (the Korean EXelon Patch and combination with mEmantine Comparative Trial study).

PubMed

Yoon, Soo J; Choi, Seong H; Na, Hae R; Park, Kyung-Won; Kim, Eun-Joo; Han, Hyun J; Lee, Jae-Hong; Shim, Young S; Na, Duk L

2017-03-01

Memantine is known to be effective in the treatment of the behavioral symptoms of dementia, especially agitation in moderate to severe Alzheimer's disease (AD). However, memantine and rivastigmine patch combination therapy has not been well studied in determining treatment effectiveness with mild to moderate AD patients. This was a multicenter, 24-week, prospective, randomized, open-label study design. A total 147 AD patients with Mini-Mental State Examination scores from 10 to 20 were randomly assigned to rivastigmine patch monotherapy and combination therapy with memantine groups. Agitation symptoms, using the Korean Version of the Cohen Mansfield Agitation Inventory were evaluated at baseline and at study end. Suppression and emergence of agitation symptoms were also evaluated. We carried out factor analyses to evaluate the interrelationship of agitation symptoms and to investigate treatment response in these symptoms. Factor analyses showed two symptom clusters: factor A - aggressive agitated behaviors - versus factor B - non-aggressive agitated behaviors. The rivastigmine patch monotherapy group showed significantly decreased factor B scores and had a tendency of decreased Korean Version of the Cohen Mansfield Agitation Inventory total scores and factor A scores. Conversely, the combination therapy group showed significantly increased Korean Version of the Cohen Mansfield Agitation Inventory total scores and factor B scores. Neither monotherapy nor combination therapy reduced the emergence of new agitation symptoms. In this trial of mild to moderate AD patients, the rivastigmine patch monotherapy group experienced a reduction of non-aggressive agitated behaviors. However, combination therapy with memantine did not show any benefit on the agitation associated with mild to moderate AD. Geriatr Gerontol Int 2017; 17: 494-499. © 2016 Japan Geriatrics Society.

A Randomized Controlled Trial Comparing Endoscopic-Assisted Versus Open Neck Tissue Expander Placement in Reconstruction of Post-Burn Facial Scar Deformities.

PubMed

As'adi, Kamran; Emami, Seyed Abolhassan; Salehi, Seyed Hamid; Shoar, Saeed

2016-08-01

Tissue expansion has evolved reconstruction surgery by providing a great source of additional tissue for large skin defects. Nevertheless, wide application of tissue expander reconstruction is challenging due to high complication rates and uncertainty about final outcomes. Recently, endoscopy has shown promise in reconstructive surgeries using tissue expander placement. This study aimed to compare outcomes between open and endoscopic-assisted neck tissue expander placement in reconstruction of post-burn facial scar deformities. Through a randomized clinical trial, 63 patients with facial burn scars were assigned to an open group or endoscopic group for placement of 81 tissue expanders. The complication rate, operative time, length of hospital stay, and time to full expansion were compared between the two groups. Thirty-one patients were assigned to the open group and 32 patients to the endoscopic group. The average operative time was significantly reduced in the endoscopic group compared with the open group (42.2 ± 3.6, 56.5 ± 4.5 min, p < 0.05). The complication rate was significantly lower in the endoscopic group than the open group (6 vs. 16, p < 0.05). Hospital stay was also significantly diminished from 26.3 ± 7.7 h in open group to 7.4 ± 4.5 h in endoscopic group (p < 0.0001). There was a significant reduction in time to full expansion in the endoscopic group as compared with the open group (93.5 ± 10.2 vs. 112.1 ± 14.2 days, p = 0.002). Endoscopic neck tissue expander placement significantly reduced operative time, the postoperative complication rate, length of hospital stay, and time to achieve full expansion and allowed early initiation of expansion and remote placement of the port in relation to the expander pocket. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Generating "Random" Integers

ERIC Educational Resources Information Center

Griffiths, Martin

2011-01-01

One of the author's undergraduate students recently asked him whether it was possible to generate a random positive integer. After some thought, the author realised that there were plenty of interesting mathematical ideas inherent in her question. So much so in fact, that the author decided to organise a workshop, open both to undergraduates and…

Open surgical simulation--a review.

PubMed

Davies, Jennifer; Khatib, Manaf; Bello, Fernando

2013-01-01

Surgical simulation has benefited from a surge in interest over the last decade as a result of the increasing need for a change in the traditional apprentice model of teaching surgery. However, despite the recent interest in surgical simulation as an adjunct to surgical training, most of the literature focuses on laparoscopic, endovascular, and endoscopic surgical simulation with very few studies scrutinizing open surgical simulation and its benefit to surgical trainees. The aim of this review is to summarize the current standard of available open surgical simulators and to review the literature on the benefits of open surgical simulation. Open surgical simulators currently used include live animals, cadavers, bench models, virtual reality, and software-based computer simulators. In the current literature, there are 18 different studies (including 6 randomized controlled trials and 12 cohort studies) investigating the efficacy of open surgical simulation using live animal, bench, and cadaveric models in many surgical specialties including general, cardiac, trauma, vascular, urologic, and gynecologic surgery. The current open surgical simulation studies show, in general, a significant benefit of open surgical simulation in developing the surgical skills of surgical trainees. However, these studies have their limitations including a low number of participants, variable assessment standards, and a focus on short-term results often with no follow-up assessment. The skills needed for open surgical procedures are the essential basis that a surgical trainee needs to grasp before attempting more technical procedures such as laparoscopic procedures. In this current climate of medical practice with reduced hours of surgical exposure for trainees and where the patient's safety and outcome is key, open surgical simulation is a promising adjunct to modern surgical training, filling the void between surgeons being trained in a technique and a surgeon achieving fluency in that open surgical procedure. Better quality research is needed into the benefits of open surgical simulation, and this would hopefully stimulate further development of simulators with more accurate and objective assessment tools. © 2013 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Comparative randomized study on the efficaciousness of treatment of BOO due to BPH in patients with prostate up to 100 gr by endoscopic gyrus prostate resection versus open prostatectomy. Preliminary data.

PubMed

Giulianelli, Roberto; Brunori, Stefano; Gentile, Barbara Cristina; Vincenti, Giorgio; Nardoni, Stefano; Pisanti, Francesco; Shestani, Teuta; Mavilla, Luca; Albanesi, Luca; Attisani, Francesco; Mirabile, Gabriella; Schettini, Manlio

2011-06-01

With the advent of medical management and minimally techniques for benign prostate hypeplasia (BPH), invasive surgical procedures such open prostatectomy (OPSU) have become less common, although selected patients may still benefit from open prostatectomy. Aim of this study was to evaluate efficacy and safety of Bipolar TURP (Gyrus electro surgical system) versus standard open prostatectomy in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) with markedly enlarged glands refractory to medical therapy. From January 2003 to January 2004, 140 patients affected by mild-severe LUTS, secondary to BOO from BPH, refractory to medical therapy, with markedly enlarged glands, were randomized in two groups (1:1), and subjected to open prostatectomy (OPSU) carried out with traditional method (Bracci Thechnique) versus transurethral resection of the prostate (TURP) utilizing the bipolar methodology. Preoperative work-up included IPSS, IIEF-5 and Qol questionnaires. All patients were submitted to uroflowmetry, transrectal ultrasound (TRUS), measurament of postvoidal residual urine and PSA determination. IPSS, IIEF-5 and Qol, uroflowmetry, TRUS, measurement of post-voidal residual urine, PSA determination and number of reoperations were evaluated at 1, 3, 6, 12, 18, 24, 30 and 36 months. Operative time, resected tissue weight and perioperative complications were also registered. Total post-operative catheter time, total postoperative hospital stay, haemoglobin loss were recorded in the 2 groups. Comparative data on IPSS symptom score, IIEF-5 and Qol, PSA, peak urinary flow rates and post-void residual urine volume in the 2 groups were similar but showed a significative improvement with respect to baseline value. Postoperative haemoglobin levels, postoperative catheterization, hospital stay and 3-yr overall surgical re-treatment-free rate were significantly better in the Bipolar group. In the treatment of LUTS due to bladder outlet obstruction (BOO) with markedly enlarged glands refractory to medical therapy, Bipolar TURP has a comparable outcome to open prostatectomy at short and medium term according to both subjective and objective outcome measures.

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

PubMed

Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

2015-10-07

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

Effect of the route of administration of methylprednisolone on oedema and trismus in impacted lower third molar surgery.

PubMed

Koçer, G; Yuce, E; Tuzuner Oncul, A; Dereci, O; Koskan, O

2014-05-01

Due to their anatomical position, the surgical removal of impacted third molars results in oedema, pain, and trismus. The purpose of this study was to evaluate the efficacy of supraperiosteal injection of methylprednisolone compared with an oral tablet form and intravenous (i.v.) injection in the prevention of postoperative pain and oedema associated with inflammation. This randomized, prospective, and controlled study included 44 patients. The patients were randomly divided into four groups: group 1 (control; no steroids), group 2 (local injection), group 3 (oral tablets), and group 4 (i.v. injection). On days 2 and 7 following surgery, linear oedema was determined using facial landmarks, and maximal mouth opening was measured. Postoperative mouth opening and swelling were evaluated for each route of methylprednisolone administration and compared. The female (59%) to male (41%) ratio was 1.44; the mean age of the patients was 29.6 years. The level of significance was set at P<0.01 for mouth opening and P<0.05 for oedema. With regard to trismus, all three routes of administration demonstrated better efficacy in comparison to the control. While oral administration and i.v. injection of methylprednisolone achieved similar results, masseter injection provided better results in reducing oedema and trismus when compared to the control following lower third molar surgery. Copyright © 2013 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Sac ligation in inguinal hernia repair: A meta-analysis of randomized controlled trials.

PubMed

Kao, Chun-Yu; Li, Ching-Li; Lin, Chao-Chun; Su, Chih-Ming; Chen, Chia-Che; Tam, Ka-Wai

2015-07-01

Traditionally, hernia sac ligation during inguinal hernia repair is considered mandatory to prevent postoperative development of hernia. However, ligation may induce postoperative pain. The aim of this study was to evaluate the outcomes of hernia sac ligation after inguinal hernia repair. We conducted a systematic review and meta-analysis of randomized controlled trials to investigate the outcomes of hernia sac ligation for open or laparoscopic inguinal hernia repair. Incidence of hernia recurrence was assessed following the surgery. The secondary outcomes included pain scores and postoperative complications. Five trials were selected and their results were summarized. These 5 trials were published between 1984 and 2014, and the sample sizes ranged from 50 to 467 patients. Four trials had recruited patients with inguinal hernia who underwent open repair, and one study enrolled patients who underwent laparoscopic procedures. We observed no difference in the incidence of hernia recurrence and postoperative complications between the sac ligation and nonligation groups. Postoperatively, the intensity of pain was significantly higher in the ligation group than in the nonligation group at Day 7 (Weight mean difference 1.46; 95% confident interval: 0.98-1.95). Hernia sac ligation was associated with higher postoperative pain, and did not show any benefit over sac nonligation regarding the incidence of recurrence and postoperative complications in patients undergoing open tension-free mesh repair or laparoscopic procedures. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

The analgesic effect of photobiomodulation therapy (830 nm) on the masticatory muscles: a randomized, double-blind study.

PubMed

Costa, Sabrina Araújo Pinho; Florezi, Giovanna Piacenza; Artes, Gisele Ebling; Costa, Jessica Ribeiro da; Gallo, Rosane Tronchin; Freitas, Patricia Moreira de; Witzel, Andrea Lusvarghi

2017-12-18

This study assesses the efficacy of photobiomodulation therapy (830 nm) for myalgia treatment of masticatory muscles. Sixty patients with muscular myalgia were selected and randomly allocated into 2 groups (n=30): Group A comprised patients given a placebo (control), and Group B consisted of those undergoing photobiomodulation therapy (PBMT). PBMT and placebo were applied bilaterally to specific points on the masseter and temporal muscles. Referred pain elicited by palpation and maximum mouth opening were measured before (EV1) and after (EV2) the treatments. The data were analyzed using statistical tests, considering a significance level of 5%. No significant differences in range were observed for active or passive mouth opening (p ≥ 0.05). Comparing the final outcomes (EV1-EV2) of both treatments, statistical significance was verified for total pain in the right masseter muscle (p = 0.001) and total pain (p = 0.005). In EV2, significant differences in pain reported with palpation were found between Groups A and B for the following: left posterior temporal muscle (p = 0.025), left superior masseter muscle (p = 0.036), inferior masseter muscle (p = 0.021), total pain (left side) (p = 0.009), total masseter muscle (left side) (p = 0.014), total temporal (left side) (p = 0.024), and total pain (p = 0.035). We concluded that PBMT (830 nm) reduces pain in algic points, but does not influence the extent of mouth opening in patients with myalgia.

Role of ranitidine in negative symptoms of schizophrenia--an open label study.

PubMed

Mehta, Varun S; Ram, Daya

2014-12-01

In this open label study, 75 patients with a diagnosis of schizophrenia were randomized to three groups of 25 each, receiving 150mg/day ranitidine, 300mg/day ranitidine and receiving only olanzapine. They were rated on PANSS at baseline, 4 and 8 weeks. There was a significant reduction in the scores of negative scale in patients receiving 300mg/day ranitidine in comparison to patients not receiving ranitidine at the end of 4 weeks but was not seen again when assessed at the end of 8 weeks. Though effective in reducing the negative symptoms, the effect was not sustained due to the tolerance to the actions of ranitidine. Copyright © 2014 Elsevier B.V. All rights reserved.

Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial.

PubMed

Ruff, Christian T; Giugliano, Robert P; Braunwald, Eugene; Mercuri, Michele; Curt, Valentin; Betcher, Joshua; Grip, Laura; Cange, Abby L; Crompton, Andrea E; Murphy, Sabina A; Deenadayalu, Naveen; Antman, Elliott M

2014-08-12

At the end of 2 previous trials, an excess of stroke and bleeding was observed in patients with AF randomized to a new oral anticoagulant (NOAC) who transitioned to a vitamin K antagonist (VKA). The ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) trial compared once-daily edoxaban to warfarin for stroke prevention in patients with AF. An end-of-trial transition plan was developed to minimize the risks of stroke due to inadequate anticoagulation and bleeding from excessive anticoagulation during this critical period. All patients on the blinded study drug at the trial's conclusion were included in this analysis. In pre-specified analyses, stroke, bleeding, and death that occurred through 30 days after the end-of-trial visit were stratified by randomized treatment allocation and open-label anticoagulant selected post-trial. Of the 13,642 patients taking the blinded study drug at the end of the trial, 9,304 (68.2%) were transitioned to open-label VKA and 4,258 patients (31.2%) to an NOAC. There were 21 strokes evenly distributed across the 3 randomized treatment arms: warfarin 7 (1.90%/year), edoxaban high dose 7 (1.89%/year), edoxaban low dose 7 (1.85%/year). Major bleeding was also similar across the 3 treatment arms: warfarin 11 (2.98%/year), edoxaban high dose 10 (2.69%/year), edoxaban low dose 18 (4.76%/year). In patients transitioned to VKA, 85% of patients had at least 1 INR ≥ 2 by day 14 after the transition and 99% by day 30. The ENGAGE AF-TIMI 48 transition plan protected patients from an excess of thrombotic and bleeding events and should be helpful in clinical practice when patients are transitioned between oral anticoagulants. (Global Study to Assess the Safety and Effectiveness of Edoxaban [DU-176b] vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation [EngageAFTIMI48]; NCT00781391). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Effects of pleasant olfactory mental imagery on the arterial oxygenation in patients with open heart surgery: A randomized controlled trial.

PubMed

Rezaei-Nodehi, Masoud; Bagheri-Nesami, Masoumeh; Shorofi, Seyed Afshin; Yazdani-Charati, Jamshid; Ghafari, Rahman

2017-11-01

Arterial hypoxemia is one of the most common respiratory complications following cardiac surgery. This study was intended to examine the effects of pleasant olfactory mental imagery on postoperative hypoxemia in patients undergoing open heart surgery. This is a randomized controlled clinical trial. The sample consisted of 80 patients who were randomly assigned to either practice olfactory mental imagery (experimental group) or receive routine care (control group). A card with the image of roses was given to patients and they were asked to look at the image, visualize the scent of roses in the mind, and then sniff as much as possible, hold their breath for 2 s and eventually exhale slowly through the nose. This procedure was consecutively repeated five times. After a fifteen-minute break, patients proceeded to practice olfactory mental imagery with other fruit images. The experimental group executed the olfactory mental imagery for two hours in the morning and two hours in the afternoon on postoperative days 1 and 2. No statistically significant differences were observed between the experimental and control groups regarding sociodemographic characteristics, medical and surgical information. This study also demonstrated that the mean Spao2 was significantly higher in the experimental group (97.400 ± 1.70) than the control group (96.465 ± 1.70) (p = 0.015). The results of this study suggest that olfactory mental imagery can improve arterial oxygenation in patients with cardiac surgery. Copyright © 2017. Published by Elsevier Ltd.

Surgical Treatment of Adolescent Clavicle Fractures: Results and Complications.

PubMed

McIntosh, Amy L

2016-06-01

No level 1 evidence is available to guide the surgical treatment of adolescent clavicle fractures. Adult literature is not applicable as adolescent mid-diaphyseal clavicle fractures do not develop nonunions, and only a small percentage (10% to 20%) are symptomatic from malunions. Current indications for operative fixation are: (1) completely displaced midshaft fracture with shortening of >2 cm; (2) superior displacement with skin tenting and/or an impending open fracture; (3) associated neurovascular injury; (4) open clavicular fracture; and (5) floating shoulder with a completely displaced clavicular fracture. Future large prospective randomized studies will need to be performed to accurately define which adolescent patients will "truly" benefit from surgical intervention.

Continuous, daily levonorgestrel/ethinyl estradiol vs. 21-day, cyclic levonorgestrel/ethinyl estradiol: efficacy, safety and bleeding in a randomized, open-label trial.

PubMed

Teichmann, Alexander; Apter, Dan; Emerich, Janusz; Greven, Klaus; Klasa-Mazurkiewicz, Dagmara; Melis, Giambi B; Spaczynski, Marek; Grubb, Gary S; Constantine, Ginger D; Spielmann, Daniele

2009-12-01

This Phase 3, randomized, open-label, multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous, daily regimen of levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg compared with a 21-day, cyclic LNG 100 mcg/EE 20 mcg regimen. Three hundred twenty-three healthy women were randomized to continuous LNG 90 mcg/EE 20 mcg and 318 subjects to cyclic LNG 100 mcg/EE 20 mcg for 1 year (13 pill packs). Pearl index, adverse event (AE) incidence and bleeding profiles were assessed. No pregnancies occurred with the continuous oral contraceptive (OC) (Pearl index=0.00). As the study progressed, the percentage of women who achieved amenorrhea during each 28-day pill pack increased: 40% at pill pack 7, 53% at pill pack 13. The percentage of women with no bleeding [with or without spotting (defined as not requiring sanitary protection)] was 50%, 69% and 79% at pill packs 3, 7 and 13, respectively. The incidence of AEs was similar to that of the cyclic OC (except for metrorrhagia and vaginal bleeding in the first 6 months). Continuous LNG 90 mcg/EE 20 mcg was shown to be a safe and effective OC in this direct comparison to a cyclic OC. Suppression of menses and the potential for no bleeding requiring sanitary protection may be provided by this continuous, low-dose OC.

Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial.

PubMed

Ferrando, Carlos; Soro, Marina; Canet, Jaume; Unzueta, Ma Carmen; Suárez, Fernando; Librero, Julián; Peiró, Salvador; Llombart, Alicia; Delgado, Carlos; León, Irene; Rovira, Lucas; Ramasco, Fernando; Granell, Manuel; Aldecoa, César; Diaz, Oscar; Balust, Jaume; Garutti, Ignacio; de la Matta, Manuel; Pensado, Alberto; Gonzalez, Rafael; Durán, M Eugenia; Gallego, Lucia; Del Valle, Santiago García; Redondo, Francisco J; Diaz, Pedro; Pestaña, David; Rodríguez, Aurelio; Aguirre, Javier; García, Jose M; García, Javier; Espinosa, Elena; Charco, Pedro; Navarro, Jose; Rodríguez, Clara; Tusman, Gerardo; Belda, Francisco Javier

2015-04-27

Postoperative pulmonary and non-pulmonary complications are common problems that increase morbidity and mortality in surgical patients, even though the incidence has decreased with the increased use of protective lung ventilation strategies. Previous trials have focused on standard strategies in the intraoperative or postoperative period, but without personalizing these strategies to suit the needs of each individual patient and without considering both these periods as a global perioperative lung-protective approach. The trial presented here aims at comparing postoperative complications when using an individualized ventilatory management strategy in the intraoperative and immediate postoperative periods with those when using a standard protective ventilation strategy in patients scheduled for major abdominal surgery. This is a comparative, prospective, multicenter, randomized, and controlled, four-arm trial that will include 1012 patients with an intermediate or high risk for postoperative pulmonary complications. The patients will be divided into four groups: (1) individualized perioperative group: intra- and postoperative individualized strategy; (2) intraoperative individualized strategy + postoperative continuous positive airway pressure (CPAP); (3) intraoperative standard ventilation + postoperative CPAP; (4) intra- and postoperative standard strategy (conventional strategy). The primary outcome is a composite analysis of postoperative complications. The Individualized Perioperative Open-lung Ventilatory Strategy (iPROVE) is the first multicenter, randomized, and controlled trial to investigate whether an individualized perioperative approach prevents postoperative pulmonary complications. Registered on 5 June 2014 with identification no. NCT02158923 .

Interesting Practitioners in Training in Empirically Supported Treatments: Research Reviews versus Case Studies

PubMed Central

Stewart, Rebecca E.; Chambless, Dianne L.

2010-01-01

It has been repeatedly demonstrated that clinicians rely more on clinical judgment than on research findings. We hypothesized that psychologists in practice might be more open to adopting empirically supported treatments (ESTs) if outcome results were presented with a case study. Psychologists in private practice (N = 742) were randomly assigned to receive a research review of data from randomized controlled trials of cognitive-behavioral treatment (CBT) and medication for bulimia, a case study of CBT for a fictional patient with bulimia, or both. Results indicated that the inclusion of case examples renders ESTs more compelling and interests clinicians in gaining training. Despite these participants’ training in statistics, the inclusion of the statistical information had no influence on attitudes or training willingness beyond that of the anecdotal case information. PMID:19899142

Driving with Intuition: A Preregistered Study about the EEG Anticipation of Simulated Random Car Accidents

PubMed Central

Duma, Gian Marco; Mento, Giovanni; Manari, Tommaso; Martinelli, Massimiliano

2017-01-01

The study of neural pre-stimulus or “anticipatory” activity opened a new window for understanding how the brain actively constructs the forthcoming reality. Usually, experimental paradigms designed to study anticipatory activity make use of stimuli. The purpose of the present study is to expand the study of neural anticipatory activity upon the temporal occurrence of dichotomic, statistically unpredictable (random) stimuli within an ecological experimental paradigm. To this purpose, we used a simplified driving simulation including two possible, randomly-presented trial types: a car crash end trial and a no car crash end trial. Event Related Potentials (ERP) were extracted -3,000 ms before stimulus onset. We identified a fronto-central negativity starting around 1,000 ms before car crash presentation. By contrast, a whole-scalp distributed positivity characterized the anticipatory activity observed before the end of the trial in the no car crash end condition. The present data are in line with the hypothesis that the brain may also anticipate dichotomic, statistically unpredictable stimuli, relaying onto different pre-stimulus ERP activity. Possible integration with car-smart-systems is also suggested. PMID:28103303

Variation in soil and forest floor characteristics along gradients of ericaceous, evergreen shrub cover in the southern Appalachians

Treesearch

Jonatha L. Horton; Barton D. Clinton; John F. Walker; Colin M. Beir; Erik T. Nilsen

2009-01-01

Ericaceous shrubs can influence soil properties in many ecosystems. In this study, we examined how soil and forest floor properties vary among sites with different ericaceous evergreen shrub basal area in the southern Appalachian mountains. We randomly located plots along transects that included open understories and understories with varying amounts of Rhododendron...

Perceptions of Civility for Mobile Phone Use in Formal and Informal Meetings

ERIC Educational Resources Information Center

Washington, Melvin C.; Okoro, Ephraim A.; Cardon, Peter W.

2014-01-01

We report our survey research about what American business professionals consider appropriate or civil mobile phone behavior during formal and informal meetings. The findings come from two of our recent research studies: an open-ended survey of 204 employees at a beverage distributor on the East Coast and a nationwide, random-sample survey of 350…

Hand Hygiene Program Decreases School Absenteeism Due to Upper Respiratory Infections

ERIC Educational Resources Information Center

Azor-Martinez, Ernestina; Cobos-Carrascosa, Elena; Seijas-Vazquez, Maria Luisa; Fernández-Sánchez, Carmen; Strizzi, Jenna M.; Torres-Alegre, Pilar; Santisteban-Martínez, Joaquin; Gimenez-Sanchez, Francisco

2016-01-01

Background: We assessed the effectiveness of a handwashing program using hand sanitizer to prevent school absenteeism due to upper respiratory infections (URIs). Methods: This was a randomized, controlled, and open study on a sample of 1341 children 4-12 years old, attending 5 state schools in Almería (Spain), with an 8-month follow-up. The…

Pre-Service Teachers' Perceptions of Effective Inquiry Instruction: Are Effective Instruction and Effective Inquiry Instruction Essentially the Same?

ERIC Educational Resources Information Center

Aulls, Mark W.; Ibrahim, Ahmed

2012-01-01

This multiple case study examined pre-service teachers perceptions of effective post-secondary instruction. Pre-service teachers were asked to write essays describing an effective teacher of their choice. Twenty-one essays were randomly selected. Data analysis involved open coding of each essay, content analysis of each essay using Anderson and…

Ketamine for cancer pain: what is the evidence?

PubMed

Jonkman, Kelly; van de Donk, Tine; Dahan, Albert

2017-06-01

In this review, we assess the benefit of ketamine in the treatment of terminal cancer pain that is refractory to opioid treatment and/or complicated by neuropathy. While randomized controlled trials consistently show lack of clinical efficacy of ketamine in treating cancer pain, a large number of open-label studies and case series show benefit. Ketamine is an N-methyl-D-aspartate receptor antagonist that at low-dose has effective analgesic properties. In cancer pain, ketamine is usually prescribed as adjuvant to opioid therapy when pain becomes opioid resistant or when neuropathic pain symptoms dominate the clinical picture. A literature search revealed four randomized controlled trials that examined the benefit of oral, subcutaneous or intravenous ketamine in opioid refractory cancer pain. None showed clinically relevant benefit in relieving pain or reducing opioid consumption. This suggests absence of evidence of benefit for ketamine as adjuvant analgesic in cancer pain. These findings contrast the benefit from ketamine observed in a large number of open-label studies and (retrospective) case series. We relate the opposite outcomes to methodological issues. The complete picture is such that there is still insufficient evidence to state with certainty that ketamine is not effective in cancer pain.

Efficacy and safety of a phytoestrogen preparation derived from Glycine max (L.) Merr in climacteric symptomatology: a multicentric, open, prospective and non-randomized trial.

PubMed

Albert, A; Altabre, C; Baró, F; Buendía, E; Cabero, A; Cancelo, M J; Castelo-Branco, C; Chantre, P; Duran, M; Haya, J; Imbert, P; Julía, D; Lanchares, J L; Llaneza, P; Manubens, M; Miñano, A; Quereda, F; Ribes, C; Vázquez, F

2002-03-01

A multicentric, open, prospective, observational and no-randomized clinical trial was carried out in Spain with 190 postmenopausal women receiving a soy preparation rich in isoflavones (PHYTO SOYA, capsules containing 17.5 mg isoflavones). The main object of the present study was to investigate its efficacy in alleviating the symptomatology derived from the lack of estrogen, mainly hot flushes, but also other symptoms such as sleep disorder, anxiety, depression, vaginal dryness, loss of libido and bone pain. Each patient received 35 mg isoflavones per day in two doses. During the four months' treatment, a statistically significant decrease in the number of hot flushes with PHYTO SOYA was experienced by 80.82% women; only 5,48% patients did not improve with the treatment. The average reduction was 47.8%, which is equivalent to 4 hot flushes. All the other studied parameters also showed a statistically significant decrease. No severe side-effects were reported and tolerance was excellent. Treatment with PHYTO SOYA resulted in a significant improvement of the symptomatology that accompanies the lack of estrogen during menopause.

Pharmacological approaches to the treatment of complicated grief: rationale and a brief review of the literature

PubMed Central

Bui, Eric; Nadal-Vicens, Mireya; M. Simon, Naomi

2012-01-01

Complicated grief (CG) is a common and often under-acknowledged cause of profound impairment experienced after the loss of a loved one. Although both clinical and basic research suggests that pharmacological agents might be of use in the treatment of CG, research on pharmacological approaches to this condition is still scarce. Three open-label trials and one randomized trial on bereavement-related depression suggest that tricyclic antidepressants may be effective, although they may be more efficacious for depressive symptoms than for grief-specific symptoms. Four open-label trials (total number of participants, 50) of selective serotonin reuptake inhibitors (SSRIs) have yielded results, providing very preliminary support that they might be effective in the treatment of CG, both as a standalone treatment and in conjunction with psychotherapeutic interventions. These more recent studies have shown an effect on both depression and grief-specific scales. Furthermore, therapeutic interventions for CG may be more effective in conjunction with SSRI administration. Given the small number of pharmacological studies to date, there is a need for randomized trials to test the potential efficacy of pharmacological agents in the treatment of CG. PMID:22754287

Prediction of 1-octanol solubilities using data from the Open Notebook Science Challenge.

PubMed

Buonaiuto, Michael A; Lang, Andrew S I D

2015-12-01

1-Octanol solubility is important in a variety of applications involving pharmacology and environmental chemistry. Current models are linear in nature and often require foreknowledge of either melting point or aqueous solubility. Here we extend the range of applicability of 1-octanol solubility models by creating a random forest model that can predict 1-octanol solubilities directly from structure. We created a random forest model using CDK descriptors that has an out-of-bag (OOB) R 2 value of 0.66 and an OOB mean squared error of 0.34. The model has been deployed for general use as a Shiny application. The 1-octanol solubility model provides reasonably accurate predictions of the 1-octanol solubility of organic solutes directly from structure. The model was developed under Open Notebook Science conditions which makes it open, reproducible, and as useful as possible.Graphical abstract.

Sensitivity of 3D Dose Verification to Multileaf Collimator Misalignments in Stereotactic Body Radiation Therapy of Spinal Tumor.

PubMed

Xin-Ye, Ni; Ren, Lei; Yan, Hui; Yin, Fang-Fang

2016-12-01

This study aimed to detect the sensitivity of Delt 4 on ordinary field multileaf collimator misalignments, system misalignments, random misalignments, and misalignments caused by gravity of the multileaf collimator in stereotactic body radiation therapy. (1) Two field sizes, including 2.00 cm (X) × 6.00 cm (Y) and 7.00 cm (X) × 6.00 cm (Y), were set. The leaves of X1 and X2 in the multileaf collimator were simultaneously opened. (2) Three cases of stereotactic body radiation therapy of spinal tumor were used. The dose of the planning target volume was 1800 cGy with 3 fractions. The 4 types to be simulated included (1) the leaves of X1 and X2 in the multileaf collimator were simultaneously opened, (2) only X1 of the multileaf collimator and the unilateral leaf were opened, (3) the leaves of X1 and X2 in the multileaf collimator were randomly opened, and (4) gravity effect was simulated. The leaves of X1 and X2 in the multileaf collimator shifted to the same direction. The difference between the corresponding 3-dimensional dose distribution measured by Delt 4 and the dose distribution in the original plan made in the treatment planning system was analyzed with γ index criteria of 3.0 mm/3.0%, 2.5 mm/2.5%, 2.0 mm/2.0%, 2.5 mm/1.5%, and 1.0 mm/1.0%. (1) In the field size of 2.00 cm (X) × 6.00 cm (Y), the γ pass rate of the original was 100% with 2.5 mm/2.5% as the statistical standard. The pass rate decreased to 95.9% and 89.4% when the X1 and X2 directions of the multileaf collimator were opened within 0.3 and 0.5 mm, respectively. In the field size of 7.00 (X) cm × 6.00 (Y) cm with 1.5 mm/1.5% as the statistical standard, the pass rate of the original was 96.5%. After X1 and X2 of the multileaf collimator were opened within 0.3 mm, the pass rate decreased to lower than 95%. The pass rate was higher than 90% within the 3 mm opening. (2) For spinal tumor, the change in the planning target volume V 18 under various modes calculated using treatment planning system was within 1%. However, the maximum dose deviation of the spinal cord was high. In the spinal cord with a gravity of -0.25 mm, the maximum dose deviation minimally changed and increased by 6.8% than that of the original. In the largest opening of 1.00 mm, the deviation increased by 47.7% than that of the original. Moreover, the pass rate of the original determined through Delt 4 was 100% with 3 mm/3% as the statistical standard. The pass rate was 97.5% in the 0.25 mm opening and higher than 95% in the 0.5 mm opening A, 0.25 mm opening A, whole gravity series, and 0.20 mm random opening. Moreover, the pass rate was higher than 90% with 2.0 mm/2.0% as the statistical standard in the original and in the 0.25 mm gravity. The difference in the pass rates was not statistically significant among the -0.25 mm gravity, 0.25 mm opening A, 0.20 mm random opening, and original as calculated using SPSS 11.0 software with P > .05. Different analysis standards of Delt 4 were analyzed in different field sizes to improve the detection sensitivity of the multileaf collimator position on the basis of 90% throughout rate. In stereotactic body radiation therapy of spinal tumor, the 2.0 mm/2.0% standard can reveal the dosimetric differences caused by the minor multileaf collimator position compared with the 3.0 mm/3.0% statistical standard. However, some position derivations of the misalignments that caused high dose amount to the spinal cord cannot be detected. However, some misalignments were not detected when a large number of multileaf collimator were administered into the spinal cord. © The Author(s) 2015.

Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Efficacy Results From a Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Papakostas, George I; Fava, Maurizio; Baer, Lee; Swee, Michaela B; Jaeger, Adrienne; Bobo, William V; Shelton, Richard C

2015-12-01

The authors sought to test the efficacy of adjunctive ziprasidone in adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram. This was an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial conducted at three academic medical centers. Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1), randomly assigned in a 1:1 ratio to receive adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo, N=68), with 8 weekly follow-up assessments. The primary outcome measure was clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D). The Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain were defined a priori as key secondary outcome measures. Rates of clinical response (35.2% compared with 20.5%) and mean improvement in HAM-D total scores (-6.4 [SD=6.4] compared with -3.3 [SD=6.2]) were significantly greater for the escitalopram plus ziprasidone group. Several secondary measures of antidepressant efficacy also favored adjunctive ziprasidone. The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score. Ten (14%) patients in the escitalopram plus ziprasidone group discontinued treatment because of intolerance, compared with none in the escitalopram plus placebo group. Ziprasidone as an adjunct to escitalopram demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.

The open quantum Brownian motions

NASA Astrophysics Data System (ADS)

Bauer, Michel; Bernard, Denis; Tilloy, Antoine

2014-09-01

Using quantum parallelism on random walks as the original seed, we introduce new quantum stochastic processes, the open quantum Brownian motions. They describe the behaviors of quantum walkers—with internal degrees of freedom which serve as random gyroscopes—interacting with a series of probes which serve as quantum coins. These processes may also be viewed as the scaling limit of open quantum random walks and we develop this approach along three different lines: the quantum trajectory, the quantum dynamical map and the quantum stochastic differential equation. We also present a study of the simplest case, with a two level system as an internal gyroscope, illustrating the interplay between the ballistic and diffusive behaviors at work in these processes. Notation H_z : orbital (walker) Hilbert space, {C}^{{Z}} in the discrete, L^2({R}) in the continuum H_c : internal spin (or gyroscope) Hilbert space H_sys=H_z\\otimesH_c : system Hilbert space H_p : probe (or quantum coin) Hilbert space, H_p={C}^2 \\rho^tot_t : density matrix for the total system (walker + internal spin + quantum coins) \\bar \\rho_t : reduced density matrix on H_sys : \\bar\\rho_t=\\int dxdy\\, \\bar\\rho_t(x,y)\\otimes | x \\rangle _z\\langle y | \\hat \\rho_t : system density matrix in a quantum trajectory: \\hat\\rho_t=\\int dxdy\\, \\hat\\rho_t(x,y)\\otimes | x \\rangle _z\\langle y | . If diagonal and localized in position: \\hat \\rho_t=\\rho_t\\otimes| X_t \\rangle _z\\langle X_t | ρt: internal density matrix in a simple quantum trajectory Xt: walker position in a simple quantum trajectory Bt: normalized Brownian motion ξt, \\xi_t^\\dagger : quantum noises

Endovascular Versus Open Surgical Intervention in Patients with Takayasu's Arteritis: A Meta-analysis.

PubMed

Jung, Jae Hyun; Lee, Young Ho; Song, Gwan Gyu; Jeong, Han Saem; Kim, Jae-Hoon; Choi, Sung Jae

2018-06-01

Although medical treatment has advanced, surgical treatment is needed to control symptoms of Takayasu's arteritis (TA), such as angina, stroke, hypertension, or claudication. Endovascular or open surgical intervention is performed; however, there are few comparative studies on these methods. This meta-analysis and systematic review aimed to examine the outcome of surgical treatment of TA. A meta-analysis comparing outcomes of endovascular and open surgical intervention was performed using MEDLINE and Embase. This meta-analysis included only observational studies, and the evidence level was low to moderate. Data were pooled and analysed using a fixed or random effects model with the I 2 statistic. The included studies involved a total of 770 patients and 1363 lesions, with 389 patients treated endovascularly and 420 treated by surgical revascularization. Restenosis was more common with endovascular than open surgical intervention (odds ratio [OR] 5.18, 95% confidence interval [CI] 2.78-9.62; p < .001). In subgroup analysis according to the involved lesions, endovascular intervention patients showed more restenosis than open surgical intervention patients in the coronary artery, supra-aortic branches, and renal artery. In both the active and inactive stages, restenosis was more common in those treated endovascularly than in those treated by open surgery. However, stroke occurred less often with endovascular intervention than with open surgical intervention (OR 0.33, 95% CI 0.12-0.90; p = .003). Mortality and complications other than stroke and mortality did not differ between endovascular and open surgical intervention. This meta-analysis has shown a lower risk of restenosis with open surgical intervention than with endovascular intervention. Stroke was generally more common with open surgical intervention than with endovascular intervention. However, there were differences according to the location of the lesion, and the risk of stroke in open surgery is higher when the supra-aortic branches are involved rather than the renal arteries. Copyright © 2018 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.

Composite quantum collision models

NASA Astrophysics Data System (ADS)

Lorenzo, Salvatore; Ciccarello, Francesco; Palma, G. Massimo

2017-09-01

A collision model (CM) is a framework to describe open quantum dynamics. In its memoryless version, it models the reservoir R as consisting of a large collection of elementary ancillas: the dynamics of the open system S results from successive collisions of S with the ancillas of R . Here, we present a general formulation of memoryless composite CMs, where S is partitioned into the very open system under study S coupled to one or more auxiliary systems {Si} . Their composite dynamics occurs through internal S -{Si} collisions interspersed with external ones involving {Si} and the reservoir R . We show that important known instances of quantum non-Markovian dynamics of S —such as the emission of an atom into a reservoir featuring a Lorentzian, or multi-Lorentzian, spectral density or a qubit subject to random telegraph noise—can be mapped on to such memoryless composite CMs.

Differentiation in Access to, and the Use and Sharing of (Open) Educational Resources among Students and Lecturers at Kenyan Universities

ERIC Educational Resources Information Center

Pete, Judith; Mulder, Fred; Neto, Jose Dutra Oliveira

2017-01-01

In order to obtain a fair "OER picture" for the Global South a large-scale study has been carried out for a series of countries, including Kenya. In this paper we report on the Kenya study, run at four universities that have been selected with randomly sampled students and lecturers. Empirical data have been generated by the use of a…

Event-level relationship between methamphetamine use significantly associated with non-adherence to pharmacologic trial medications in event-level analyses.

PubMed

Hermanstyne, Keith A; Santos, Glenn-Milo; Vittinghoff, Eric; Santos, Deirdre; Colfax, Grant; Coffin, Phillip

2014-10-01

Methamphetamine use has been previously associated with poor medication adherence, but, to date, there have been no studies that have conducted event-level analyses on correlates of medication adherence in studies of pharmacologic agents for methamphetamine dependence. We pooled data from two previous, randomized controlled trials (using bupropion and mirtazapine, respectively) for methamphetamine dependence and used a mixed effects logistic model to examine correlates of daily opening of the medication event monitoring system (MEMS) cap as a repeated measure. We explored whether periods of observed methamphetamine use via urine testing were associated with study medication adherence based on MEMS cap openings. We found a significant negative association between methamphetamine-urine positivity and event-level study medication adherence as measured by MEMS cap openings (AOR: 0.69; 95% CI: 0.49-0.98). In addition, age (AOR: 1.07; 95% CI: 1.02-1.11) and depressive symptoms (AOR: 0.78; 95% CI: 0.64-0.90) were significantly associated with adherence. Finally, participants were more likely to open their study medication bottles on days when they presented for in-person urine testing. Our event-level analysis shows that methamphetamine use can be associated with reduced medication adherence as measured by MEMS cap openings in pharmacologic trials, which corroborates prior research. These findings may suggest that medication adherence support in pharmacologic trials among methamphetamine users may be needed to improve study compliance and could be targeted towards periods of time when there are more likely to not open their study medication pill bottles. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A Comparison Between the Hemodynamic Effects of Cisatracurium and Atracurium in Patient with Low Function of Left Ventricle who are Candidate for Open Heart Surgery.

PubMed

Ghorbanlo, Masoud; Mohaghegh, Mahmoud Reza; Yazdanian, Forozan; Mesbah, Mehrdad; Totonchi, Ziya

2016-07-27

The need for muscle relaxants in general anesthesia in different surgeries including cardiac surgeries, and the type of relaxant to be used considering its different hemodynamic effects on patients with heart disease can be of considerable importance. In this study, the hemodynamic effects of two muscle relaxants, Cisatracurium and Atracurium in patients whit low function of left ventricle who are candidate for open heart surgery have been considered. This study has been designed as a randomized prospective double-blind clinical trial. The target population included all adult patients with heart disease whose ejection fraction reported by echocardiography or cardiac catheterization was 35% or less before the surgery, and were candidate for open heart surgery in Shahid Rajaei Heart Center. Taking into account the inclusion and exclusion criteria, the patients were randomly placed in two groups of 30 people each. In the induction stage, all the patients received midazolam, etomidate, and one of the considered muscle relaxant, either 0.2 mg/kg of cisatracurium or 0.5mg/kg of Atracurium within one minute. In the maintenance stage of anesthesia, the patients were administered by infusion of midazolam, sufentanil and the same muscle relaxant used in the induction stage. The hemodynamic indexes were recorded and evaluated in different stages of anesthesia and surgery as well as prior to transfer to ICU. In regard with descriptive indexes (age and sex distributions, premedication with cardiac drugs, ejection fraction before surgery, basic disease) there was no statistically significant difference between the groups. The significant difference of hemodynamic indexes between the two groups of this study, and the need for hemodynamic stability in all stages of surgery for patients with low function of left ventricle who are candidate for open heart surgery, proves that administering Cisatracurium as the muscle relaxant is advantageous and better.

Efficacy of a standardized herbal preparation (Roidosanal®) in the treatment of hemorrhoids: A randomized, controlled, open-label multicentre study

PubMed Central

Aggrawal, Kapil; Satija, Naveen; Dasgupta, Gita; Dasgupta, Partha; Nain, Parul; Sahu, Aditya R.

2014-01-01

Background: Catechins and epicatechins are monomers of naturally occurring proanthocyanidins, which have been reported with free radical scavenging, antioxidant, antiinflammatory, antiallergic, and vasodilatory properties. Plant parts rich in proanthocyanidins have been used for years in treatment of various ano-rectal diseases. This study compares the efficacy of two herbal preparations, Daflon® 500 mg and Roidosanal®, in ameliorating the signs and symptoms associated with hemorrhoids. Objective: To evaluate the safety and to compare the efficacy of a herbal preparation, Roidosanal® versus Daflon® 500 mg, on signs and symptoms of hemorrhoidal disease. Materials and Methods: In this pilot, active controlled, open-labeled multicentre study, 73 patients with proctoscopy proven hemorrhoids (Grade I to III) were randomly assigned to receive either Roidosanal® (Gr R; n = 37) or Daflon® 500 mg (Gr D; n = 36), for 15 days, at three centers in India. Assessment of hemorrhoidal symptoms was carried out in all patients at different time points. Intent-to-treat analysis was performed for both primary and secondary endpoints. Results: Baseline characteristics were comparable between the two groups. Both products were found to be equally effective in improving the ano-rectal conditions in Grade I and Grade II hemorrhoids; however, Roidosanal® demonstrated better efficacy in patients with Grade III hemorrhoids. Hemorrhoids associated symptoms like bleeding, pain, etc., improved in both groups, although intergroup comparisons were comparable. Conclusion: Both Roidosanal® and Daflon® 500 mg were equally effective in resolving signs and symptoms of hemorrhoids. Roidosanal® can be tried as a safe and effective treatment option for treatment of hemorrhoids. Further randomized, double-blind and large multicentre studies are recommended. PMID:24948863

Immediate mobilization following fixation of mandible fractures: a prospective, randomized study.

PubMed

Kaplan, B A; Hoard, M A; Park, S S

2001-09-01

To compare outcomes of open reduction and internal fixation of displaced mandible fractures followed by either immediate mobilization or 2 weeks of mandibular-maxillary fixation. A prospective, randomized, single-blinded study was performed. The study was performed between January 1, 1997, and March 30, 2000. Inclusion criteria were displaced fractures between the mandibular angles, age greater than 16 years, and no involvement of the alveolus, ramus, condyles, or maxilla. All fractures were repaired by means of open reduction and internal fixation using 2.0-mm titanium plates secured either in transoral fashion or percutaneously. Data were collected at 6-week and 3- and 6-month postoperative examinations. Variables were assessed by a surgeon blinded to the history of immobilization and included pain, malunion or nonunion, occlusion, trismus, wound status, infection rates, dental hygiene, and weight loss. Twenty-nine consecutive patients were enrolled, 16 patients to immediate function and 13 patients to 2 weeks of mandibular-maxillary fixation. No statistically significant differences were found between groups for any of the variables. Immediate release and temporary immobilization showed mean weight loss of 10 and 8 pounds and trismus of 4.2 and 4.6 cm, respectively. One wound separation and one infection were seen in the immobilization population, and no wound separation or infection was seen in the immediate-release group. Dental hygiene was similar between the groups. No malunion or nonunion was noted in either group. In this prospective and randomized study, no significant differences were noted between the groups receiving either immediate release or 2 weeks of mandibular-maxillary fixation. The findings support the treatment of selective mandible fractures with 2.0-mm miniplates and immediate mobilization.

C2 Nerve Field Stimulation for the Treatment of Fibromyalgia: A Prospective, Double-blind, Randomized, Controlled Cross-over Study.

PubMed

Plazier, Mark; Ost, Jan; Stassijns, Gaëtane; De Ridder, Dirk; Vanneste, Sven

2015-01-01

Fibromyalgia is a condition characterized by widespread chronic pain. Due to the high prevalence and high costs, it has a substantial burden on society. Treatment results are diverse and only help a small subset of patients. C2 nerve field stimulation, aka occipital nerve stimulation, is helpful and a minimally invasive treatment for primary headache syndromes. Small C2 pilot studies seem to be beneficial in fibromyalgia. Forty patients were implanted with a subcutaneous electrode in the C2 dermatoma as part of a prospective, double-blind, randomized, controlled cross-over study followed by an open label follow up period of 6 months. The patients underwent 2 week periods of different doses of stimulation consisting of minimal (.1 mA), subthreshold, and suprathreshold (for paresthesias) in a randomized order. Twenty seven patients received a permanent implant and 25 completed the 6 month open label follow up period. During the 6 week trial phase of the study, patients had an overall decrease of 36% on the fibromyalgia impact questionnaire (FIQ), a decrease of 33% fibromyalgia pain and improvement of 42% on the impact on daily life activities and quality. These results imply an overall improvement in the disease burden, maintained at 6 months follow up, as well as an improvement in life quality of 50%. Seventy six percent of patients were satisfied or very satisfied with their treatment. There seems to be a dose-response curve, with increasing amplitudes leading to better clinical outcomes. Subcutaneous C2 nerve field stimulation seems to offer a safe and effective treatment option for selected medically intractable patients with fibromyalgia. Copyright © 2015 Elsevier Inc. All rights reserved.

Robotic versus Open Thyroidectomy for Differentiated Thyroid Cancer: An Evidence-Based Review.

PubMed

Liu, Shirley Yuk Wah; Ng, Enders Kwok Wai

2016-01-01

While open thyroidectomy (OT) is advocated as the gold standard treatment for differentiated thyroid cancer, the contemporary use of robotic thyroidectomy (RT) is often controversial. Although RT combines the unique benefits of the surgical robot and remote access thyroidectomy, its applicability on cancer patients is challenged by the questionable oncological benefits and safety. This review aims to analyze the current literature evidence in comparing RT to OT on thyroid cancers for their perioperative and oncological outcomes. To date, no randomized controlled trial is available in comparing RT to OT. All published studies are nonrandomized or retrospective comparisons. Current data suggests that RT compares less favorably than OT for longer operative time, higher cost, and possibly inferior oncological control with lower number of central lymph nodes retrieved. In terms of morbidity, quality of life outcomes, and short-term recurrence rates, RT and OT are comparable. While conventional OT continues to be appropriate for most thyroid cancers, RT should better be continued by expert surgeons on selected patients who have low-risk thyroid cancers and have high expectations on cosmetic outcomes. Future research should embark on prospective randomized studies for unbiased comparisons. Long-term follow-up studies are also needed to evaluate outcomes on recurrence and survival.

Implementation and evaluation of an interprofessional simulation-based education program for undergraduate nursing students in operating room nursing education: a randomized controlled trial.

PubMed

Wang, Rongmei; Shi, Nianke; Bai, Jinbing; Zheng, Yaguang; Zhao, Yue

2015-07-09

The present study was designed to implement an interprofessional simulation-based education program for nursing students and evaluate the influence of this program on nursing students' attitudes toward interprofessional education and knowledge about operating room nursing. Nursing students were randomly assigned to either the interprofessional simulation-based education or traditional course group. A before-and-after study of nursing students' attitudes toward the program was conducted using the Readiness for Interprofessional Learning Scale. Responses to an open-ended question were categorized using thematic content analysis. Nursing students' knowledge about operating room nursing was measured. Nursing students from the interprofessional simulation-based education group showed statistically different responses to four of the nineteen questions in the Readiness for Interprofessional Learning Scale, reflecting a more positive attitude toward interprofessional learning. This was also supported by thematic content analysis of the open-ended responses. Furthermore, nursing students in the simulation-based education group had a significant improvement in knowledge about operating room nursing. The integrated course with interprofessional education and simulation provided a positive impact on undergraduate nursing students' perceptions toward interprofessional learning and knowledge about operating room nursing. Our study demonstrated that this course may be a valuable elective option for undergraduate nursing students in operating room nursing education.

Comparison of submuscular and open plating of pediatric femur fractures: a retrospective review.

PubMed

Abbott, Matthew D; Loder, Randall T; Anglen, Jeffrey O

2013-01-01

Plate osteosynthesis is an accepted method of treatment of pediatric femur fractures. Historically, open plating has been used. Submuscular bridge plating has gained recent popularity due to the theoretical advantages of decreased operative time, decreased blood loss, and decreased risk for infection. The purpose of this study was to compare submuscular bridge plating to open plating of pediatric femur fractures. We retrospectively reviewed 79 patients (80 treated femur fractures) between 1999 and 2011 that underwent either open plating (58 femur fractures) or submuscular bridge plating (22 femur fractures). The outcome measures evaluated were operative time, estimated blood loss, malunion, leg length discrepancy, time to union, infection, unplanned return to the operating room, and length of hospital stay after surgery. Among our outcome measures, there was no difference between the 2 groups in terms of operative time, leg length discrepancy, time to union, infection, or length of hospital stay after surgery. There was greater estimated blood loss in the open plating group (P≤0.0001) and greater rotational asymmetry in the submuscular bridge plating group (P=0.005). There was a trend of increased unplanned return to the operating room in the open plating group (5/58 vs. 0/22) although not statistically significant (P=0.32). Submuscular bridge plating and open plating seem to be equally viable options for the management of pediatric diaphyseal femur fractures. In this study, open plating had an increase in estimated blood loss and a trend of more unplanned returns to the operating room, whereas submuscular bridge plating had an increase in asymptomatic rotational asymmetry. Further larger, prospective, randomized studies are necessary to further evaluate these operative techniques. Therapeutic Level III.

Local rhBMP-12 on an Absorbable Collagen Sponge as an Adjuvant Therapy for Rotator Cuff Repair - A Phase 1, Randomized, Standard of Care Control, Multicenter Study: Safety and Feasibility.

PubMed

Greiner, Stefan; Ide, Junji; Van Noort, Arthur; Mochizuki, Yu; Ochi, Hiroshi; Marraffino, Shannon; Sridharan, Sudhakar; Rudicel, Sally; Itoi, Eiji

2015-08-01

Recombinant human bone morphogenetic protein-12 (rhBMP-12) has been shown to induce tendon and ligament formation in rats and to improve tendon healing; however, the safety and feasibility of implanting rhBMP-12/absorbable collagen sponge (ACS) in humans are not known. To investigate the safety and feasibility of rhBMP-12 on an ACS as an adjuvant therapy in open rotator cuff repair. Randomized controlled trial; Level of evidence, 2. This study consisted of 20 patients with full-thickness rotator cuff tears. Patients were randomized either to standard of care (SOC) treatment (open rotator cuff repair) or to receive 0.015 mg/mL rhBMP-12/ACS and SOC treatment during their open rotator cuff repair (rhBMP-12/ACS group) at a rate of 1/4 SOC/rhBMP-12/ACS. The feasibility of implanting the product and the safety of the product were evaluated during the 1-year follow-up period. The evaluation involved up to 10 postoperative visits, which included physical examinations, radiographs, computed tomography (CT) scans, magnetic resonance imaging (MRI) scans with an emphasis on heterotopic ossification (HO), pharmacokinetics, immunogenicity, laboratory evaluations, and local and systemic adverse events at specified time points. Small amounts of HO were seen on follow-up CT scans in 10 of 16 patients in the rhBMP-12/ACS group and in 2 of 3 patients in the SOC group. HO did not increase at 26 weeks and was not associated with any adverse events or unsatisfactory clinical outcomes. Pharmacokinetics demonstrated that circulating levels of rhBMP-12 were not detectable after administration. Five of 16 patients showed a postoperative immunogenic response but did not show any correlating adverse events. Complete healing of the rotator cuff was observed in 14 of 16 patients; 2 of 16 imaging results could not be analyzed because of artifacts in the rhBMP-12 group on MRI scans. In the SOC group, 1 of 4 patients showed a retear at 12 weeks after surgery. The use of rhBMP-12/ACS has been shown to be feasible and safe in a concentration of 0.015 mg/mL when used in open rotator cuff repair. Higher dose concentrations of rhBMP-12 should be evaluated in the future to evaluate their safety and potential to increase rotator cuff healing after open surgical repair. © 2015 The Author(s).

Group Cognitive Behavioural Therapy and Group Recreational Activity for Adults with Autism Spectrum Disorders: A Preliminary Randomized Controlled Trial

ERIC Educational Resources Information Center

Hesselmark, Eva; Plenty, Stephanie; Bejerot, Susanne

2014-01-01

Although adults with autism spectrum disorder are an increasingly identified patient population, few treatment options are available. This "preliminary" randomized controlled open trial with a parallel design developed two group interventions for adults with autism spectrum disorders and intelligence within the normal range: cognitive…

Metastability of Reversible Random Walks in Potential Fields

NASA Astrophysics Data System (ADS)

Landim, C.; Misturini, R.; Tsunoda, K.

2015-09-01

Let be an open and bounded subset of , and let be a twice continuously differentiable function. Denote by the discretization of , , and denote by the continuous-time, nearest-neighbor, random walk on which jumps from to at rate . We examine in this article the metastable behavior of among the wells of the potential F.

Randomized withdrawal study of patients with symptomatic neurogenic orthostatic hypotension responsive to droxidopa.

PubMed

Biaggioni, Italo; Freeman, Roy; Mathias, Christopher J; Low, Phillip; Hewitt, L Arthur; Kaufmann, Horacio

2015-01-01

We evaluated whether droxidopa, a prodrug converted to norepinephrine, is beneficial in the treatment of symptomatic neurogenic orthostatic hypotension, which results from failure to generate an appropriate norepinephrine response to postural challenge. Patients with symptomatic neurogenic orthostatic hypotension and Parkinson disease, multiple system atrophy, pure autonomic failure, or nondiabetic autonomic neuropathy underwent open-label droxidopa titration (100-600 mg, 3× daily). Responders then received an additional 7-day open-label treatment at their individualized dose. Patients were subsequently randomized to continue with droxidopa or withdraw to placebo for 14 days. We then assessed patient-reported scores on the Orthostatic Hypotension Questionnaire and blood pressure measurements. Mean worsening of Orthostatic Hypotension Questionnaire dizziness/lightheadedness score from randomization to end of study (the primary outcome; N=101) was 1.9±3.2 with placebo and 1.3±2.8 units with droxidopa (P=0.509). Four of the other 5 Orthostatic Hypotension Questionnaire symptom scores and all 4 symptom-impact scores favored droxidopa, with statistical significance for the patient's self-reported ability to perform activities requiring standing a short time (P=0.033) and standing a long time (P=0.028). Furthermore, a post hoc analysis of a predefined composite score of all symptoms (Orthostatic Hypotension Questionnaire composite) demonstrated a significant benefit for droxidopa (P=0.013). There was no significant difference between groups for standing systolic blood pressure (P=0.680). Droxidopa was well tolerated. In summary, this randomized withdrawal droxidopa study failed to meet its primary efficacy end point. Additional clinical trials are needed to confirm that droxidopa is beneficial in symptomatic neurogenic orthostatic hypotension, as suggested by the positive secondary outcomes of this trial. http://www.clinicaltrials.gov. Unique identifier: NCT00633880. © 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wolters Kluwer.

Hypnosis/Relaxation therapy for temporomandibular disorders: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Zhang, Yuqing; Montoya, Luis; Ebrahim, Shanil; Busse, Jason W; Couban, Rachel; McCabe, Randi E; Bieling, Peter; Carrasco-Labra, Alonso; Guyatt, Gordon H

2015-01-01

To conduct a systematic review and meta-analysis to evaluate the effectiveness of hypnosis/relaxation therapy compared to no/minimal treatment in patients with temporomandibular disorders (TMD). Studies reviewed included randomized controlled trials (RCTs) where investigators randomized patients with TMD or an equivalent condition to an intervention arm receiving hypnosis, relaxation training, or hyporelaxation therapy, and a control group receiving no/minimal treatment. The systematic search was conducted without language restrictions, in Medline, EMBASE, CENTRAL, and PsycINFO, from inception to June 30, 2014. Studies were pooled using weighted mean differences and pooled risk ratios (RRs) for continuous outcomes and dichotomous outcomes, respectively, and their associated 95% confidence intervals (CI). Of 3,098 identified citations, 3 studies including 159 patients proved eligible, although none of these described their method of randomization. The results suggested limited or no benefit of hypnosis/relaxation therapy on pain (risk difference in important pain -0.06; 95% CI: -0.18 to 0.05; P = .28), or on pressure pain thresholds on the skin surface over the temporomandibular joint (TMJ) and masticatory muscles. Low-quality evidence suggested some benefit of hypnosis/relaxation therapy on maximal pain (mean difference on 100-mm scale = -28.33; 95% CI: -44.67 to -11.99; P =.007) and active maximal mouth opening (mean difference on 100-mm scale = -2.63 mm; 95% CI: -3.30 mm to -1.96 mm; P < .001) compared to no/minimal treatment. Three RCTs were eligible for the systematic review, but they were with high risk of bias and provided low-quality evidence, suggesting that hypnosis/relaxation therapy may have a beneficial effect on maximal pain and active maximal mouth opening but not on pain and pressure pain threshold. Larger RCTs with low risk of bias are required to confirm or refute these findings and to inform other important patient outcomes.

Remote magnetic with open-irrigated catheter vs. manual navigation for ablation of atrial fibrillation: a systematic review and meta-analysis.

PubMed

Proietti, Riccardo; Pecoraro, Valentina; Di Biase, Luigi; Natale, Andrea; Santangeli, Pasquale; Viecca, Maurizio; Sagone, Antonio; Galli, Alessio; Moja, Lorenzo; Tagliabue, Ludovica

2013-09-01

The aim of this study was to determine the efficacy and safety of remote magnetic navigation (RMN) with open-irrigated catheter vs. manual catheter navigation (MCN) in performing atrial fibrillation (AF) ablation. We searched in PubMed (1948-2013) and EMBASE (1974-2013) studies comparing RMN with MCN. Outcomes considered were AF recurrence (primary outcome), pulmonary vein isolation (PVI), procedural complications, and data on procedure's performance. Odds ratios (OR) and mean difference (MD) were extracted and pooled using a random-effect model. Confidence in the estimates of the obtained effects (quality of evidence) was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. We identified seven controlled trials, six non-randomized and one randomized, including a total of 941 patients. Studies were at high risk of bias. No difference was observed between RMN and MCN on AF recurrence [OR 1.18, 95% confidence interval (CI) 0.85 to 1.65, P = 0.32] or PVI (OR 0.41, 95% CI 0.11-1.47, P = 0.17). Remote magnetic navigation was associated with less peri-procedural complications (Peto OR 0.41, 95% CI 0.19-0.88, P = 0.02). Mean fluoroscopy time was reduced in RMN group (-22.22 min; 95% CI -42.48 to -1.96, P = 0.03), although the overall duration of the procedure was longer (60.91 min; 95% CI 31.17 to 90.65, P < 0.0001). In conclusion, RMN is not superior to MCN in achieving freedom from recurrent AF at mid-term follow-up or PVI. The procedure implies less peri-procedural complications, requires a shorter fluoroscopy time but a longer total procedural time. For the low quality of the available evidence, a proper designed randomized controlled trial could turn the direction and the effect of the dimensions explored.

An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy

PubMed Central

Bai, Wen-Jun; Li, Hong-Jun; Dai, Yu-Tian; He, Xue-You; Huang, Yi-Ran; Liu, Ji-Hong; Sorsaburu, Sebastian; Ji, Chen; Jin, Jian-Jun; Wang, Xiao-Feng

2015-01-01

The study was to compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in Chinese men naïve to phosphodiesterase 5 (PDE5) inhibitor therapies. This multicenter, randomized, open-label, crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil. After a 4 weeks baseline assessment, 383 eligible patients were randomized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension. Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Questionnaire (PITPQ). Secondary efficacy was analyzed by PITPQ Question 2, the International Index of Erectile Function (IIEF) erectile function (EF) domain, sexual encounter profile (SEP) Questions 2 and 3, and the Drug Attributes Questionnaire. Three hundred and fifty men (91%) completed the randomized treatment phase. Two hundred and forty-two per 350 (69.1%) patients preferred 20-mg tadalafil, and 108/350 (30.9%) preferred 100-mg sildenafil (P < 0.001) as their treatment in the 8 weeks extension. Ninety-two per 242 (38%) patients strongly preferred tadalafil and 37/108 (34.3%) strongly the preferred sildenafil. The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups. For patients who preferred tadalafil, getting an erection long after taking the medication was the most reported reason for tadalafil preference. The only treatment-emergent adverse event reported by > 2% of men was headache. After tadalafil and sildenafil treatments, more Chinese men with ED naïve to PDE5 inhibitor preferred tadalafil. Both sildenafil and tadalafil treatments were effective and safe. PMID:25370206

An open-label, multicenter, randomized, crossover study comparing sildenafil citrate and tadalafil for treating erectile dysfunction in Chinese men naïve to phosphodiesterase 5 inhibitor therapy.

PubMed

Bai, Wen-Jun; Li, Hong-Jun; Dai, Yu-Tian; He, Xue-You; Huang, Yi-Ran; Liu, Ji-Hong; Sorsaburu, Sebastian; Ji, Chen; Jin, Jian-Jun; Wang, Xiao-Feng

2015-01-01

The study was to compare treatment preference, efficacy, and tolerability of sildenafil citrate (sildenafil) and tadalafil for treating erectile dysfunction (ED) in Chinese men naοve to phosphodiesterase 5 (PDE5) inhibitor therapies. This multicenter, randomized, open-label, crossover study evaluated whether Chinese men with ED preferred 20-mg tadalafil or 100-mg sildenafil. After a 4 weeks baseline assessment, 383 eligible patients were randomized to sequential 20-mg tadalafil per 100-mg sildenafil or vice versa for 8 weeks respectively and then chose which treatment they preferred to take during the 8 weeks extension. Primary efficacy was measured by Question 1 of the PDE5 Inhibitor Treatment Preference Questionnaire (PITPQ). Secondary efficacy was analyzed by PITPQ Question 2, the International Index of Erectile Function (IIEF) erectile function (EF) domain, sexual encounter profile (SEP) Questions 2 and 3, and the Drug Attributes Questionnaire. Three hundred and fifty men (91%) completed the randomized treatment phase. Two hundred and forty-two per 350 (69.1%) patients preferred 20-mg tadalafil, and 108/350 (30.9%) preferred 100-mg sildenafil (P < 0.001) as their treatment in the 8 weeks extension. Ninety-two per 242 (38%) patients strongly preferred tadalafil and 37/108 (34.3%) strongly the preferred sildenafil. The SEP2 (penetration), SEP3 (successful intercourse), and IIEF-EF domain scores were improved in both tadalafil and sildenafil treatment groups. For patients who preferred tadalafil, getting an erection long after taking the medication was the most reported reason for tadalafil preference. The only treatment-emergent adverse event reported by > 2% of men was headache. After tadalafil and sildenafil treatments, more Chinese men with ED naοve to PDE5 inhibitor preferred tadalafil. Both sildenafil and tadalafil treatments were effective and safe.

Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial

PubMed Central

2011-01-01

Background Institutionalized older persons have a poor functional capacity. Including physical exercise in their routine activities decreases their frailty and improves their quality of life. Whole-body vibration (WBV) training is a type of exercise that seems beneficial in frail older persons to improve their functional mobility, but the evidence is inconclusive. This trial will compare the results of exercise with WBV and exercise without WBV in improving body balance, muscle performance and fall prevention in institutionalized older persons. Methods/Design An open, multicentre and parallel randomized clinical trial with blinded assessment. 160 nursing home residents aged over 65 years and of both sexes will be identified to participate in the study. Participants will be centrally randomised and allocated to interventions (vibration or exercise group) by telephone. The vibration group will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm) over a six-week training period (3 sessions/week). The exercise group will perform the same exercise protocol but without a vibration stimuli platform. The primary outcome measure is the static/dynamic body balance. Secondary outcomes are muscle strength and, number of new falls. Follow-up measurements will be collected at 6 weeks and at 6 months after randomization. Efficacy will be analysed on an intention-to-treat (ITT) basis and 'per protocol'. The effects of the intervention will be evaluated using the "t" test, Mann-Witney test, or Chi-square test, depending on the type of outcome. The final analysis will be performed 6 weeks and 6 months after randomization. Discussion This study will help to clarify whether WBV training improves body balance, gait mobility and muscle strength in frail older persons living in nursing homes. As far as we know, this will be the first study to evaluate the efficacy of WBV for the prevention of falls. Trial Registration ClinicalTrials.gov: NCT01375790 PMID:22192313

A single dose, randomized, open-label, cross-over bioequivalence study of sildenafil citrate tablets in healthy Chinese volunteers
.

PubMed

Li, Dai; Wang, Yu-Lu; Xu, Su-Mei; Li, Dan; Li, Xiao-Min; Pan, Jing; Xu, Ping-Sheng

2017-02-01

The present study was designed to evaluate the bioequivalence of a newly developed sildenafil citrate tablet 50 mg (Jinge^®, Test) and a marketed counterpart (Viagra^®, 100 mg, Reference) in healthy adult male Chinese volunteers. This single-dose, randomized, open-label, four-period, and two-treatment self-crossover study included two parts: fasting and postprandial studies. In each part of the study, the subjects were randomly assigned to receive test or reference products (100 mg sildenafil) in a 1 : 1 ratio, and then received the alternative products, following a 1-week washout period. Plasma sildenafil concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Tolerability was assessed during the entire study period. 32 healthy volunteers (aged 19 - 30) were enrolled in the study; 31 volunteers completed the fasting study, while 32 volunteers completed the postprandial study. The test formulation was bioequivalent to the marketed formulation as the 90% CIs for the ratio of geometric means of C_max (fasting: 98.79 - 119.61%; fed: 94.47 - 119.65%), AUC_last (fasting: 98.70 - 109.71%; fed: 96.39 - 112.89%), and AUC_∞ (fasting: 98.45 - 108.87%; fed: 96.36 - 112.74%) were within equivalence limits (80 - 125%) under both fasting and postprandial conditions. When sildenafil was given with high-fat meals, mean C_max was reduced by 23%, and median tmax ranged from 0.75 to 1.50 hours (p ≤ 0.05). However, both AUC_last and AUC_∞ were comparable between fasting and postprandial conditions. No serious adverse events were found among the subjects. This study confirmed that test and reference sildenafil citrate tablets were bioequivalent under fasting and postprandial conditions.
.

Effect of homeopathy on analgesic intake following knee ligament reconstruction: a phase III monocentre randomized placebo controlled study

PubMed Central

Paris, A; Gonnet, N; Chaussard, C; Belon, P; Rocourt, F; Saragaglia, D; Cracowski, J L

2008-01-01

Aims The efficacy of homeopathy is still under debate. The objective of this study was to assess the efficacy of homeopathic treatment (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) on cumulated morphine intake delivered by PCA over 24 h after knee ligament reconstruction. Methods This was an add-on randomized controlled study with three parallel groups: a double-blind homeopathic or placebo arm and an open-label noninterventional control arm. Eligible patients were 18–60 years old candidates for surgery of the anterior cruciate ligament. Treatment was administered the evening before surgery and continued for 3 days. The primary end-point was cumulated morphine intake delivered by PCA during the first 24 h inferior or superior/equal to 10 mg day−1. Results One hundred and fifty-eight patients were randomized (66 in the placebo arm, 67 in the homeopathic arm and 25 in the noninterventional group). There was no difference between the treated and the placebo group for primary end-point (mean (95% CI) 48% (35.8, 56.3), and 56% (43.7, 68.3), required less than 10 mg day−1 of morphine in each group, respectively). The homeopathy treatment had no effect on morphine intake between 24 and 72 h or on the visual analogue pain scale, or on quality of life assessed by the SF-36 questionnaire. In addition, these parameters were not different in patients enrolled in the open-label noninterventional control arm. Conclusions The complex of homeopathy tested in this study was not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. What is already known about this subject The efficacy of homeopathy is still under debate and a recent meta-analysis recommended further randomized double-blind clinical trials to identify any clinical situation in which homeopathy might be effective. What this study adds The complex of homeopathy tested in this study (Arnica montana 5 CH, Bryonia alba 5 CH, Hypericum perforatum 5 CH and Ruta graveolens 3 DH) is not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction. PMID:18251757

The Effect of Food or Omeprazole on the Pharmacokinetics of Osimertinib in Patients With Non-Small-Cell Lung Cancer and in Healthy Volunteers.

PubMed

Vishwanathan, Karthick; Dickinson, Paul A; Bui, Khanh; Cassier, Philippe A; Greystoke, Alastair; Lisbon, Eleanor; Moreno, Victor; So, Karen; Thomas, Karen; Weilert, Doris; Yap, Timothy A; Plummer, Ruth

2018-04-01

Two phase 1, open-label studies assessed the impact of food or gastric pH modification (omeprazole) on the exposure and safety/tolerability of osimertinib and its metabolites. The food effect study was an open-label, 2-period crossover study in patients with advanced non-small-cell lung cancer, randomized into 2 treatment sequences: single-dose osimertinib 80 mg in a fed then fasted state or fasted then fed. The gastric pH study was an open-label, 2-period fixed sequence study assessing the effect of omeprazole on osimertinib exposure in healthy male volunteers. In period 1, volunteers received omeprazole 40 mg (days 1-4), then omeprazole 40 mg plus osimertinib 80 mg (day 5). In period 2, volunteers received osimertinib 80 mg alone (single dose). Blood samples were collected at prespecified time points for pharmacokinetic analyses. Safety/tolerability was also assessed. In the food effect study 38 patients were randomized to fed/fasted (n = 18) or fasted/fed (n = 20) sequences with all patients completing treatment. Coadministration with food did not affect osimertinib exposure (geometric least-squares mean ratios [90% confidence intervals]: 106.05% [94.82%, 118.60%] [area under the plasma concentration time curve from zero to 72 hours] and 92.75% [81.40%, 105.68%] [maximum plasma concentration]). In the gastric pH study (n = 68 received treatment, n = 47 completed the study), coadministration with omeprazole did not affect osimertinib exposure (geometric least-squares mean ratios 106.66% [100.26%, 113.46%] [area under the concentration-time curve], 101.65% [94.65%, 109.16%] [peak concentration]). Osimertinib was well tolerated in both studies. Osimertinib may be administered without regard to food. Dose restriction is not required in patients whose gastric pH may be altered by concomitant agents or medical conditions. ClinicalTrials.gov: NCT02224053, NCT02163733. © 2017, The American College of Clinical Pharmacology.

Students’ Spatial Ability through Open-Ended Approach Aided by Cabri 3D

NASA Astrophysics Data System (ADS)

Priatna, N.

2017-09-01

The use of computer software such as Cabri 3D for learning activities is very unlimited. Students can adjust their learning speed according to their level of ability. Open-ended approach strongly supports the use of computer software in learning, because the goal of open-ended learning is to help developing creative activities and mathematical mindset of students through problem solving simultaneously. In other words, creative activities and mathematical mindset of students should be developed as much as possible in accordance with the ability of spatial ability of each student. Spatial ability is the ability of students in constructing and representing geometry models. This study aims to determine the improvement of spatial ability of junior high school students who obtained learning with open-ended approach aided by Cabri 3D. It adopted a quasi-experimental method with the non-randomized control group pretest-posttest design and the 2×3 factorial model. The instrument of the study is spatial ability test. Based on analysis of the data, it is found that the improvement of spatial ability of students who received open-ended learning aided by Cabri 3D was greater than students who received expository learning, both as a whole and based on the categories of students’ initial mathematical ability.

Lactobacillus GG for treatment of acute childhood diarrhoea: An open labelled, randomized controlled trial

PubMed Central

Aggarwal, Sunny; Upadhyay, Amit; Shah, Dheeraj; Teotia, Neeraj; Agarwal, Astha; Jaiswal, Vijay

2014-01-01

Background & objectives: Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG) in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India. Methods: In this open labelled, randomized controlled trial 200 children with acute watery diarrhoea, aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. Primary outcomes were duration of diarrhoea and time to change in consistency of stools. Results: Median (inter quartile range) duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72) h vs. 78 (72-90) h; P<0.001]. Also, there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group [36 (30-36) h vs. 42 (36-48) h; P<0.001]. There was significant reduction in average number of stools per day in LGG group (P<0.001) compared to the control group. These benefits were seen irrespective of rotavirus positivity in stool tests. Interpretation & conclusions: Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group. PMID:24820831

Prospective Nonrandomized Comparative Study of Laparoscopic Versus Open Surgical Staging for Endometrial Cancer in India.

PubMed

Ansar P P; Ayyappan S; Mahajan, Vikash

2018-06-01

Laparoscopic procedures to treat endometrial cancer are currently emerging. At present, we have evidence to do laparoscopic oncologic resections for endometrial cancer as proven by many prospective studies from abroad such as LAP2 by GOG. So, we have decided to assess the safety and feasibility of such a study in our population with the following as our primary objectives: (1) to study whether laparoscopy is better compared to open approach in terms of duration of hospital stay, perioperative morbidity and early recovery from surgical trauma and (2) to study whether the laparoscopic approach is noninferior to the open approach in terms of number of lymph nodes harvested in lymphadenectomy and rate of conversion to open surgery. We did a prospective nonrandomized comparative study of open versus laparoscopy approach for surgical staging of endometrial cancer from 16th May 2013 to 15th May 2015. To prove a significant difference in the hospital stay, we needed 29 patients in each arm. Thirty patients in each arm were enrolled for the study. The median duration of stay in the open arm was 7 days and in the laparoscopy arm it was 5 days. The advantage of 2 days in the laparoscopic arm was statistically significant ( P value 0.006). Forty percent of patients in the open arm had to stay in the hospital for more than 7 days whereas only 3% of patients in the laparoscopy arm required to stay for more than 7 days ( P value 0.001). This difference was statistically significant. There was no significant difference between the early complication rates between the two arms (20% in open vs. 13% in laparoscopy; P value 0.730). There was a conversion rate of 10% in laparoscopy. The median number of nodes harvested in open arm was 16.50 and in the laparoscopy arm, it was 13.50. The difference was not statistically significant ( P value 0.086). Laparoscopy approach for endometrial cancer staging is feasible in Indian patients and the short-term advantages are replicable with same oncologic safety as proved by randomized controlled trials.

Open versus endovascular repair of ruptured abdominal aortic aneurysms: What have we learned after more than 2 decades of ruptured endovascular aneurysm repair?

PubMed

Robinson, William P

2017-12-01

Ruptured abdominal aortic aneurysm is one of the most difficult clinical problems in surgical practice, with extraordinarily high morbidity and mortality. During the past 23 years, the literature has become replete with reports regarding ruptured endovascular aneurysm repair. A variety of study designs and databases have been utilized to compare ruptured endovascular aneurysm repair and open surgical repair for ruptured abdominal aortic aneurysm and studies of various designs from different databases have yielded vastly different conclusions. It therefore remains controversial whether ruptured endovascular aneurysm repair improves outcomes after ruptured abdominal aortic aneurysm in comparison to open surgical repair. The purpose of this article is to review the best available evidence comparing ruptured endovascular aneurysm repair and open surgical repair of ruptured abdominal aortic aneurysm, including single institution and multi-institutional retrospective observational studies, large national population-based studies, large national registries of prospectively collected data, and randomized controlled clinical trials. This article will analyze the study designs and databases utilized with their attendant strengths and weaknesses to understand the sometimes vastly different conclusions the studies have reached. This article will attempt to integrate the data to distill some of the lessons that have been learned regarding ruptured endovascular aneurysm repair and identify ongoing needs in this field. Copyright © 2017 Elsevier Inc. All rights reserved.

Saxagliptin, a potent, selective inhibitor of DPP-4, does not alter the pharmacokinetics of three oral antidiabetic drugs (metformin, glyburide or pioglitazone) in healthy subjects.

PubMed

Patel, C G; Kornhauser, D; Vachharajani, N; Komoroski, B; Brenner, E; Handschuh del Corral, M; Li, L; Boulton, D W

2011-07-01

To evaluate the pharmacokinetic interactions of the potent, selective, dipeptidyl peptidase-4 inhibitor, saxagliptin, in combination with metformin, glyburide or pioglitazone. To assess the effect of co-administration of saxagliptin with oral antidiabetic drugs (OADs) on the pharmacokinetics and tolerability of saxagliptin, 5-hydroxy saxagliptin, metformin, glyburide, pioglitazone and hydroxy-pioglitazone, analyses of variance were performed on maximum (peak) plasma drug concentration (C(max)), area under the plasma concentration-time curve from time zero to infinity (AUC(∞)) [saxagliptin + metformin (study 1) and saxagliptin + glyburide (study 2)] and area under the concentration-time curve from time 0 to time t (AUC) [saxagliptin + pioglitazone (study 3)] for each analyte in the respective studies. Studies 1 and 2 were open-label, randomized, three-period, three-treatment, crossover studies, and study 3 was an open-label, non-randomized, sequential study in healthy subjects. Co-administration of saxagliptin with metformin, glyburide or pioglitazone did not result in clinically meaningful alterations in the pharmacokinetics of saxagliptin or its metabolite, 5-hydroxy saxagliptin. Following co-administration of saxagliptin, there were no clinically meaningful alterations in the pharmacokinetics of metformin, glyburide, pioglitazone or hydroxy-pioglitazone. Saxagliptin was generally safe and well tolerated when administered alone or in combination with metformin, glyburide or pioglitazone. Saxagliptin can be co-administered with metformin, glyburide or pioglitazone without a need for dose adjustment of either saxagliptin or these OADs. © 2011 Blackwell Publishing Ltd.

The impact of system level factors on treatment timeliness: utilizing the Toyota Production System to implement direct intake scheduling in a semi-rural community mental health clinic.

PubMed

Weaver, Addie; Greeno, Catherine G; Goughler, Donald H; Yarzebinski, Kathleen; Zimmerman, Tina; Anderson, Carol

2013-07-01

This study examined the effect of using the Toyota Production System (TPS) to change intake procedures on treatment timeliness within a semi-rural community mental health clinic. One hundred randomly selected cases opened the year before the change and 100 randomly selected cases opened the year after the change were reviewed. An analysis of covariance demonstrated that changing intake procedures significantly decreased the number of days consumers waited for appointments (F(1,160) = 4.9; p = .03) from an average of 11 to 8 days. The pattern of difference on treatment timeliness was significantly different between adult and child programs (F(1,160) = 4.2; p = .04), with children waiting an average of 4 days longer than adults for appointments. Findings suggest that small system level changes may elicit important changes and that TPS offers a valuable model to improve processes within community mental health settings. Results also indicate that different factors drive adult and children's treatment timeliness.

The Impact of System Level Factors on Treatment Timeliness: Utilizing the Toyota Production System to Implement Direct Intake Scheduling in a Semi-Rural Community Mental Health Clinic

PubMed Central

Weaver, A.; Greeno, C.G.; Goughler, D.H.; Yarzebinski, K.; Zimmerman, T.; Anderson, C.

2013-01-01

This study examined the effect of using the Toyota Production System (TPS) to change intake procedures on treatment timeliness within a semi-rural community mental health clinic. One hundred randomly selected cases opened the year before the change and one hundred randomly selected cases opened the year after the change were reviewed. An analysis of covariance (ANCOVA) demonstrated that changing intake procedures significantly decreased the number of days consumers waited for appointments (F(1,160)=4.9; p=.03) from an average of 11 days to 8 days. The pattern of difference on treatment timeliness was significantly different between adult and child programs (F(1,160)=4.2; p=.04), with children waiting an average of 4 days longer than adults for appointments. Findings suggest that small system level changes may elicit important changes and that TPS offers a valuable model to improve processes within community mental health settings. Results also indicate that different factors drive adult and children’s treatment timeliness. PMID:23576137

Effect of Laparoscopic-Assisted Resection vs Open Resection on Pathological Outcomes in Rectal Cancer: The ALaCaRT Randomized Clinical Trial.

PubMed

Stevenson, Andrew R L; Solomon, Michael J; Lumley, John W; Hewett, Peter; Clouston, Andrew D; Gebski, Val J; Davies, Lucy; Wilson, Kate; Hague, Wendy; Simes, John

2015-10-06

Laparoscopic procedures are generally thought to have better outcomes than open procedures. Because of anatomical constraints, laparoscopic rectal resection may not be better because of limitations in performing an adequate cancer resection. To determine whether laparoscopic resection is noninferior to open rectal cancer resection for adequacy of cancer clearance. Randomized, noninferiority, phase 3 trial (Australasian Laparoscopic Cancer of the Rectum; ALaCaRT) conducted between March 2010 and November 2014. Twenty-six accredited surgeons from 24 sites in Australia and New Zealand randomized 475 patients with T1-T3 rectal adenocarcinoma less than 15 cm from the anal verge. Open laparotomy and rectal resection (n = 237) or laparoscopic rectal resection (n = 238). The primary end point was a composite of oncological factors indicating an adequate surgical resection, with a noninferiority boundary of Δ = -8%. Successful resection was defined as meeting all the following criteria: (1) complete total mesorectal excision, (2) a clear circumferential margin (≥1 mm), and (3) a clear distal resection margin (≥1 mm). Pathologists used standardized reporting and were blinded to the method of surgery. A successful resection was achieved in 194 patients (82%) in the laparoscopic surgery group and 208 patients (89%) in the open surgery group (risk difference of -7.0% [95% CI, -12.4% to ∞]; P = .38 for noninferiority). The circumferential resection margin was clear in 222 patients (93%) in the laparoscopic surgery group and in 228 patients (97%) in the open surgery group (risk difference of -3.7% [95% CI, -7.6% to 0.1%]; P = .06), the distal margin was clear in 236 patients (99%) in the laparoscopic surgery group and in 234 patients (99%) in the open surgery group (risk difference of -0.4% [95% CI, -1.8% to 1.0%]; P = .67), and total mesorectal excision was complete in 206 patients (87%) in the laparoscopic surgery group and 216 patients (92%) in the open surgery group (risk difference of -5.4% [95% CI, -10.9% to 0.2%]; P = .06). The conversion rate from laparoscopic to open surgery was 9%. Among patients with T1-T3 rectal tumors, noninferiority of laparoscopic surgery compared with open surgery for successful resection was not established. Although the overall quality of surgery was high, these findings do not provide sufficient evidence for the routine use of laparoscopic surgery. Longer follow-up of recurrence and survival is currently being acquired. anzctr.org Identifier: ACTRN12609000663257.

Can We Make Definite Categorization of Student Attitudes? A Rough Set Approach to Investigate Students' Implicit Attitudinal Typologies toward Living Things

ERIC Educational Resources Information Center

Narli, Serkan; Yorek, Nurettin; Sahin, Mehmet; Usak, Muhammet

2010-01-01

This study investigates the possibility of analyzing educational data using the theory of rough sets which is mostly employed in the fields of data analysis and data mining. Data were collected using an open-ended conceptual understanding test of the living things administered to first-year high school students. The responses of randomly selected…

Multicenter, Randomized, Controlled Study Comparing Tafluprost/Timolol Fixed Combination with Latanoprost/Timolol Fixed Combination in Primary Open-Angle Glaucoma and Ocular Hypertension.

PubMed

Suzuki, Katsuyoshi; Otsuka, Naomi; Hizaki, Hiroko; Hashimoto, Masayo; Kuwayama, Yasuaki

2018-06-05

This was the first exploratory randomized controlled study to compare the efficacy and safety of a preserved tafluprost/timolol fixed combination (TAF/TIM) with a preserved latanoprost/timolol fixed combination (LAT/TIM). This prospective, randomized, open-label study was conducted in Japanese patients with primary open-angle glaucoma, including normal-tension glaucoma or ocular hypertension. Following a 4-week LAT/TIM run-in period, eligible patients entered a 12-week treatment period, during which they received either LAT/TIM or TAF/TIM. The efficacy endpoint was the change in intraocular pressure (IOP) from baseline to week 12 and the safety endpoints included the changes from baseline to week 12 in superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), and hyperemia score, as well as adverse events (AEs). At week 6, ocular symptoms were evaluated using a questionnaire. In total, 131 patients provided informed consent. Of these, 115 completed the run-in period and were assigned to receive TAF/TIM (n = 60) or LAT/TIM (n = 55). At week 12, there were no significant differences between the TAF/TIM and LAT/TIM groups in the change from baseline in trough IOP and IOP at 4-6 h after instillation. There were no significant differences between the two groups in the change from baseline to week 12 in SPK score, TBUT, and hyperemia score. However, only in the TAF/TIM group, the total SPK score and the inferior cornea SPK score were significantly lower at week 12 compared with baseline. Eye irritation and eye pain were significantly decreased in the TAF/TIM group compared with the LAT/TIM group. Two treatment-related AEs were reported in the TAF/TIM group (3.3%) and none in the LAT/TIM group, while no serious AEs were reported in either group. TAF/TIM is as effective as LAT/TIM in terms of IOP-reducing effect, with fewer ocular symptoms. TAF/TIM was associated with a significant improvement in SPK scores. UMIN Clinical Trials Registry Identifier, UMIN000023862. Santen Pharmaceutical Co., Ltd., Osaka, Japan.

Using Random Parameter Logit in Open and Distance Learning (ODL) Institutions in Malaysia

ERIC Educational Resources Information Center

Chiam, Chooi Chea; Loo, SzeWei

2015-01-01

Attention has been drawn to Open Distance Learning (ODL) as a mode for teaching and learning with the advancement in communication via the Internet. Education today has expanded the role of ICT in learning and knowledge generation, leveraging on Internet technology to transmit education across the country. Due to the advancement of technology and…

Efficacy of Formoterol Fumarate Delivered by Metered Dose Inhaler Using Co-Suspension™ Delivery Technology Versus Foradil® Aerolizer® in Moderate-To-Severe COPD: A Randomized, Dose-Ranging Study.

PubMed

Sethi, Sanjay; Fogarty, Charles; Hanania, Nicola A; Martinez, Fernando J; Rennard, Stephen; Fries, Michael; Orevillo, Chad; Darken, Patrick; St Rose, Earl; Strom, Shannon; Fischer, Tracy; Golden, Michael; Dwivedi, Sarvajna; Reisner, Colin

2016-11-17

Background: Co-Suspension™ Delivery Technology offers a novel pharmaceutical platform for inhaled drug therapy. This randomized, double-blind, placebo-controlled, single-dose study (NCT01349868) evaluated the efficacy of a range of doses for formoterol fumarate (FF) delivered using Co-Suspension delivery technology via a pressurized metered dose inhaler (MDI) versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Secondary objectives included determination of non-inferior efficacy and systemic exposure compared with open-label Foradil ® 12 μg (Foradil ® Aerolizer ® ; formoterol fumarate dry powder inhaler). Methods: Patients received each of the 6 study treatments (FF MDI [7.2, 9.6 and 19.2μg], placebo MDI and open-label Foradil ® [12 and 24µg]), separated by 3-10 days. Spirometry was performed 60 and 30 minutes prior to and at regular intervals up to 12 hours post-administration of study drug. The primary outcome measure was the change in forced expiratory volume in 1 second (FEV 1 ) area under the curve between 0 and 12 hours (AUC 0-12 ) relative to test day baseline. Results: A total of 50 patients were randomized to study treatment sequences. All doses of FF MDI demonstrated superiority to placebo ( p <0.0001) and non-inferiority to Foradil ® 12μg, on bronchodilator outcome measures. No serious adverse events were reported during the study. Conclusions: This study demonstrates non-inferiority of bronchodilator response and bioequivalent exposure of FF MDI 9.6μg to Foradil ® 12μg, with both agents exhibiting a similar safety profile in patients with moderate-to-severe COPD. This study supports the selection of FF MDI 9.6µg for further evaluation in Phase III trials.

CMB seen through random Swiss Cheese

NASA Astrophysics Data System (ADS)

Lavinto, Mikko; Räsänen, Syksy

2015-10-01

We consider a Swiss Cheese model with a random arrangement of Lemaȋtre-Tolman-Bondi holes in ΛCDM cheese. We study two kinds of holes with radius rb=50 h-1 Mpc, with either an underdense or an overdense centre, called the open and closed case, respectively. We calculate the effect of the holes on the temperature, angular diameter distance and, for the first time in Swiss Cheese models, shear of the CMB . We quantify the systematic shift of the mean and the statistical scatter, and calculate the power spectra. In the open case, the temperature power spectrum is three orders of magnitude below the linear ISW spectrum. It is sensitive to the details of the hole, in the closed case the amplitude is two orders of magnitude smaller. In contrast, the power spectra of the distance and shear are more robust, and agree with perturbation theory and previous Swiss Cheese results. We do not find a statistically significant mean shift in the sky average of the angular diameter distance, and obtain the 95% limit |Δ DA/bar DA|lesssim 10-4. We consider the argument that areas of spherical surfaces are nearly unaffected by perturbations, which is often invoked in light propagation calculations. The closed case is consistent with this at 1σ, whereas in the open case the probability is only 1.4%.

Randomized controlled trial of anterior-chamber intraocular lenses in Nepal: long-term follow-up.

PubMed Central

Evans, J. R.; Henning, A.; Pradhan, D.; Foster, A.; Lagnado, R.; Poulson, A.; Johnson, G. J.; Wormald, R. P.

2000-01-01

Most of the estimated 20 million people who are blind with cataracts live in rural areas of developing countries, where expert surgical resources are scarce. We have studied the use of multiflex open-loop anterior-chamber intraocular lenses (ACIOL) in high-volume low-cost surgery. Between 1992 and 1995, a total of 2000 people attending Lahan Eye Hospital, Nepal, with bilateral cataracts reducing vision to < or = 6/36 were randomly allocated to receive intracapsular extraction (ICCE) with aphakic spectacles, or ICCE with an ACIOL. We re-examined the cohort (1305/2000, 65%) between November 1996 and April 1997 and report the findings in this article. There were 13 new cases of poor visual outcome (best corrected vision < 6/60) arising after one year: 9 in the ACIOL group and 4 in the control group; odds ratio 2.1 (95% confidence interval, 0.59-9.55). The causes of poor outcome were as follows: ACIOL group--retinal detachment (4 cases), cystoid macular oedema (2), epiretinal membrane (1), age-related macular degeneration (1), and late endophthalmitis (1); control group--retinal detachment (2 cases), late endophthalmitis (1), and primary open-angle glaucoma with age-related macular degeneration (1). In rural areas of developing countries, well-manufactured multiflex open-loop ACIOLs can be implanted safely by experienced ophthalmologists after routine ICCE, avoiding the disadvantages of aphakic spectacle correction. PMID:10812737

Renal histopathology features according to various warm ischemia times in porcine laparoscopic and open surgery model

PubMed Central

Sabbagh, Robert; Chawla, Arun; Tisdale, Britton; Kwan, Kevin; Chatterjee, Suman; Kwiecien, Jacek M.; Kapoor, Anil

2011-01-01

Background Thirty minutes has been considered as the threshold for tolerable warm ischemic time (WIT). Recent reports demonstrate recovery of renal function after longer WIT. We assessed renal histology according to different WIT in a 2-kidney porcine model. Methods Twelve female pigs were randomized to an open or laparoscopic group. Each pig was further randomized within each group to clamping the left renal artery for 5, 15, 30, 45, 60 or 180 minutes. Preclamping left renal biopsies were performed on each pig. The contralateral kidney in each animal was used as an individual control. On postoperative day 14, all animals underwent bilateral nephrectomies. Preclamping left renal biopsies and all renal specimens were evaluated by a blinded veterinary pathologist. Results One pig died in the open group after 180 minutes of clamping. Histopathology did not show any significant changes between the two groups and across clamp times from 5 to 60 minutes. After 180 minutes of laparoscopic clamping, there was evidence of diffuse necrosis. Interpretation Sixty minutes of ischemia did not show any permanent renal damage in both groups. Further studies are needed to verify these findings in humans. A prolonged ischemic time without permanent renal damage would be helpful in partial nephrectomy. Warm ischemic time of 180 minutes exceeded the renal ischemic burden based on histological features. PMID:21470513

Anisotropy in Fracking: A Percolation Model for Observed Microseismicity

NASA Astrophysics Data System (ADS)

Norris, J. Quinn; Turcotte, Donald L.; Rundle, John B.

2015-01-01

Hydraulic fracturing (fracking), using high pressures and a low viscosity fluid, allow the extraction of large quantiles of oil and gas from very low permeability shale formations. The initial production of oil and gas at depth leads to high pressures and an extensive distribution of natural fractures which reduce the pressures. With time these fractures heal, sealing the remaining oil and gas in place. High volume fracking opens the healed fractures allowing the oil and gas to flow to horizontal production wells. We model the injection process using invasion percolation. We use a 2D square lattice of bonds to model the sealed natural fractures. The bonds are assigned random strengths and the fluid, injected at a point, opens the weakest bond adjacent to the growing cluster of opened bonds. Our model exhibits burst dynamics in which the clusters extend rapidly into regions with weak bonds. We associate these bursts with the microseismic activity generated by fracking injections. A principal object of this paper is to study the role of anisotropic stress distributions. Bonds in the y-direction are assigned higher random strengths than bonds in the x-direction. We illustrate the spatial distribution of clusters and the spatial distribution of bursts (small earthquakes) for several degrees of anisotropy. The results are compared with observed distributions of microseismicity in a fracking injection. Both our bursts and the observed microseismicity satisfy Gutenberg-Richter frequency-size statistics.

An Analysis of Two Layers of Encryption to Protect Network Traffic

DTIC Science & Technology

2010-06-01

Published: 06/18/2001 CVSS Severity: 7.5 (HIGH) CVE-2001-1141 Summary: The Pseudo-Random Number Generator (PRNG) in SSLeay and OpenSSL be- fore 0.9.6b allows...x509cert function in KAME Racoon successfully verifies certifi- cates even when OpenSSL validation fails, which could allow remote attackers to...montgomery function in crypto/bn/bn mont.c in OpenSSL 0.9.8e and earlier does not properly perform Montgomery multiplication, which might allow local users to

Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb: The WOLLF Randomized Clinical Trial.

PubMed

Costa, Matthew L; Achten, Juul; Bruce, Julie; Tutton, Elizabeth; Petrou, Stavros; Lamb, Sarah E; Parsons, Nick R

2018-06-12

Open fractures of the lower limb occur when a broken bone penetrates the skin. There can be major complications from these fractures, which can be life-changing. To assess the disability, rate of deep infection, and quality of life in patients with severe open fracture of the lower limb treated with negative pressure wound therapy (NPWT) vs standard wound management after the first surgical debridement of the wound. Multicenter randomized trial performed in the UK Major Trauma Network, recruiting 460 patients aged 16 years or older with a severe open fracture of the lower limb from July 2012 through December 2015. Final outcome data were collected through November 2016. Exclusions were presentation more than 72 hours after injury and inability to complete questionnaires. NPWT (n = 226) in which an open-cell solid foam or gauze was placed over the surface of the wound and connected to a suction pump, creating a partial vacuum over the dressing, vs standard dressings not involving application of negative pressure (n = 234). Disability Rating Index score (range, 0 [no disability] to 100 [completely disabled]) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. Secondary outcomes were complications including deep infection and quality of life (score ranged from 1 [best possible] to -0.59 [worst possible]; minimal clinically important difference, 0.08) collected at 3, 6, 9, and 12 months. Among 460 patients who were randomized (mean age, 45.3 years; 74% men), 88% (374/427) of available study participants completed the trial. There were no statistically significant differences in the patients' Disability Rating Index score at 12 months (mean score, 45.5 in the NPWT group vs 42.4 in the standard dressing group; mean difference, -3.9 [95% CI, -8.9 to 1.2]; P = .13), in the number of deep surgical site infections (16 [7.1%] in the NPWT group vs 19 [8.1%] in the standard dressing group; difference, 1.0% [95% CI, -4.2% to 6.3%]; P = .64), or in quality of life between groups (difference in EuroQol 5-dimensions questionnaire, 0.02 [95% CI, -0.05 to 0.08]; Short Form-12 Physical Component Score, 0.5 [95% CI, -3.1 to 4.1] and Mental Health Component Score, -0.4 [95% CI, -2.2 to 1.4]). Among patients with severe open fracture of the lower limb, use of NPWT compared with standard wound dressing did not improve self-rated disability at 12 months. The findings do not support this treatment for severe open fractures. isrctn.org Identifier: ISRCTN33756652.

A prospective, randomized trial comparing the short- and long-term results of doppler-guided transanal hemorrhoid dearterialization with mucopexy versus excision hemorrhoidectomy for grade III hemorrhoids.

PubMed

De Nardi, Paola; Capretti, Giovanni; Corsaro, Antonino; Staudacher, Carlo

2014-03-01

Few randomized trials have compared the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy and excisional open hemorrhoidectomy. Few studies have reported long-term results. The aim of this study is to evaluate the results of Doppler-guided transanal hemorrhoid dearterialization with mucopexy compared with excisional open hemorrhoidectomy in patients with grade III hemorrhoids. This is a prospective randomized study registered at clinicaltrials.gov (NCT01263431). A power analysis assessed the study's sample size. Patients were randomly assigned to undergo either hemorrhoidectomy or Doppler-guided hemorrhoid dearterialization plus mucopexy. The χ test, Mann-Whitney U test, Student t test, and a regression model were used, as appropriate. This study was conducted at the Department of Surgery, San Raffaele Scientific Institute, Milan, Italy. Fifty consecutive patients were treated for grade III hemorrhoids from July to November 2010. The primary outcome was postoperative pain. The secondary outcomes included postoperative morbidity, the resumption of social and/or working activity, patient satisfaction, and the relapse of symptoms at 1 and 24 months. No major complications occurred in either group. The median visual analog scale scores for pain in the hemorrhoidectomy and Doppler-guided dearterialization plus mucopexy groups on days 1, 7, 14, and 30 were 7 vs 5.5, 3 vs 2.5, 1 vs 0, and 0 vs 0 (p> 0.05). The median work resumption day was the 22nd in the hemorrhoidectomy group and the 10th in the Doppler-guided dearterialization plus mucopexy group (p = 0.09). Patient satisfaction at 1 and 24 postoperative months, with the use of a 4-point scale, was 3 vs 4 and 4 vs 4 (p > 0.05). During the follow-up, 2 patients in the dearterialization group required ambulatory treatment, and 1 patient in each group required further surgery for symptom relapse. Nonvalidated questionnaires were used in the follow-up. Cost analysis was not performed. Compared with hemorrhoidectomy, dearterialization with mucopexy resulted in similar postoperative pain and morbidity, and a similar long-term cure rate.

Pharmacokinetic profile of extended-release versus immediate-release oral naproxen sodium after single and multiple dosing under fed and fasting conditions: two randomized, open-label trials.

PubMed

Laurora, Irene; Wang, Yuan

2016-10-01

Extended-release (ER) naproxen sodium provides pain relief for up to 24 hours with a single dose (660 mg/day). Its pharmacokinetic profile after single and multiple dosing was compared to immediate release (IR) naproxen sodium in two randomized, open-label, crossover studies, under fasting and fed conditions. Eligible healthy subjects were randomized to ER naproxen sodium 660-mg tablet once daily or IR naproxen sodium 220-mg tablet twice daily (440 mg initially, followed by 220 mg 12 hours later). Primary variables: pharmacokinetic parameters after singleday administration (day 1) and at steady state after multiple-day administration (day 6). Total exposure was comparable for both treatments under fasting and fed conditions. After fasting: peak naproxen concentrations were slightly lower with ER naproxen sodium than with IR naproxen sodium but were reached at a similar time. Fed conditions: mean peak concentrations were comparable but reached after a longer time with ER vs. IR naproxen sodium. ER naproxen sodium was well tolerated, with a similar safety profile to IR naproxen sodium. The total exposure of ER naproxen sodium (660 mg) is comparable to IR naproxen sodium (220 mg) when administered at the maximum over the counter (OTC) dose of 660-mg daily dose on a single day and over multiple days. The rate of absorption is delayed under fed conditions.

Generating Random Numbers by Means of Nonlinear Dynamic Systems

ERIC Educational Resources Information Center

Zang, Jiaqi; Hu, Haojie; Zhong, Juhua; Luo, Duanbin; Fang, Yi

2018-01-01

To introduce the randomness of a physical process to students, a chaotic pendulum experiment was opened in East China University of Science and Technology (ECUST) on the undergraduate level in the physics department. It was shown chaotic motion could be initiated through adjusting the operation of a chaotic pendulum. By using the data of the…

Basic Religious Beliefs and Personality Traits

PubMed Central

Rajaei, Ali Reza; Sarvarazemy, Ahmad

2012-01-01

Objective Spiritual beliefs can help people find meaning of life, and can also influence their feelings, behaviors and mental health. The present research studied the relationship between basic religious beliefs (Human, Existence and God) and five personality factors: neuroticism, extraversion, openness, agreeableness, conscientiousness. Method One hundred seventy eight students of Islamic Azad University in Torbat-jam were randomly selected and completed the basic religious beliefs and NEO Questionnaires. Results Data showed that basic religious beliefs have a significant negative correlation with neuroticism (r=-0.29),and a significant positive relationship with extraversion(r=0.28),openness(r=0.14),agreeableness (r=0.29),and conscientiousness (r=0.48). Also, the results of the regression analysis showed that basic religious beliefs can anticipate neuroticism, extraversion, agreeableness and conscientiousness, but they cannot anticipate the openness factor significantly. Conclusion The findings of this study demonstrate that basic religious beliefs have a positive relationship with good characteristics that help people resolve the challenges of their lives and identity crisis. Thus, the results of this study support the idea of Religious Cognitive–Emotional Theory that religiosity is correlated with positive personality traits. PMID:22952550

Multiwavelength ytterbium-Brillouin random Rayleigh feedback fiber laser

NASA Astrophysics Data System (ADS)

Wu, Han; Wang, Zinan; Fan, Mengqiu; Li, Jiaqi; Meng, Qingyang; Xu, Dangpeng; Rao, Yunjiang

2018-03-01

In this letter, we experimentally demonstrate the multiwavelength ytterbium-Brillouin random fiber laser for the first time, in the half-open cavity formed by a fiber loop mirror and randomly distributed Rayleigh mirrors. With a cladding-pumped ytterbium-doped fiber and a long TrueWave fiber, the narrow linewidth Brillouin pump can generate multiple Brillouin Stokes lines with hybrid ytterbium-Brillouin gain. Up to six stable channels with a spacing of about 0.06 nm are obtained. This work extends the operation wavelength of the multiwavelength Brillouin random fiber laser to the 1 µm band, and has potential in various applications.

Intravitreal ranibizumab as an adjunct for Ahmed valve surgery in open-angle glaucoma: a pilot study.

PubMed

Desai, Rajen U; Singh, Kuldev; Lin, Shan C

2013-03-01

To determine the safety and efficacy of intravitreal ranibizumab therapy before and after Ahmed tube insertion for open-angle glaucoma as a means of optimizing postoperative intraocular pressure control. Randomized, controlled trial. Open-angle glaucoma patients scheduled for Ahmed tube insertion, randomized to ranibizumab or control groups. Ranibizumab (0.5 mg in 0.05 mL) was administered intravitreally at three time points: 9 days prior to surgery, 1 month post-surgery and 2 months post-surgery. Control patients underwent the same procedure without ranibizumab. Success at 6 months postoperatively was defined as intraocular pressure <18 mmHg with no adjunctive medications or intraocular pressure <15 mmHg with one adjunctive medication. The study and control arms included six and five subjects, respectively, with four in each arm undergoing combined cataract surgery. In the ranibizumab arm, the preoperative and postoperative intraocular pressure/medication usage was 21.0 ± 6.7 mmHg on 3.2 ± 1.5 medications and 14.7 ± 1.9 mmHg on 0.5 ± 0.8 medications, respectively. In the control arm, preoperative and postoperative intraocular pressure/medication usage was 18.8 ± 3.8 mmHg on 2.8 ± 1.3 medications and 16.2 ± 3.6 mmHg with 1.8 ± 1.6 medications, respectively. Success was achieved in 83% of subjects in the ranibizumab group compared with 40% in the control group (two-tailed Fisher's exact test, P = 0.24). The findings from this small pilot comparative study suggest that intravitreal ranibizumab use may be a safe and potentially effective adjunctive treatment modality in improving success after Ahmed tube placement. © 2012 The Authors. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists.

Trails through time: A geologist's guide to Jefferson County open space parks

USGS Publications Warehouse

Reed, John C.

2014-01-01

Jefferson County Open Space Parks, as well as other nearby parks and National Forest lands, offer marvelousopportunities to explore the geologic story behind this singular landscape. At first the distribution of rocks of differentages and types seems almost random, but careful study of the rocks and landscape features reveals a captivatinggeologic story, a history that tells of the building of the foundations of the continent, the rise and destruction of longvanishedmountain ranges, the ebb and flow of ancient seas, and the constant shaping and reshaping of the landscape inresponse to the never-ending interplay between uplift and erosion. This historical account is constantly being improvedand expanded as new evidence accumulates and new interpretations evolve.

Opening and retraction of particulate soap films

NASA Astrophysics Data System (ADS)

Timounay, Yousra; Lorenceau, Elise; Rouyer, Florence

2015-07-01

We study for the first time the bursting dynamics of thin liquid films laden with hydrophobic micronic particles either with free or constrained edges. We highlight that the particles can arrange in bilayer or monolayer configurations and explore a range of particles coverage from zero to random close packing. When the particles bridge the two interfaces (monolayer configuration) of free-edge films, the hole opens intermittently. For the other cases, we observe constant retraction velocities, modeled by balancing liquid and particles inertia against surface tension as in Taylor-Culick theory. But, this approach is only valid up to a critical value of particles coverage due to the interplay between the interfaces and the friction between particles.

The investigation of the lateral interaction effect's on traffic flow behavior under open boundaries

NASA Astrophysics Data System (ADS)

Bouadi, M.; Jetto, K.; Benyoussef, A.; El Kenz, A.

2017-11-01

In this paper, an open boundaries traffic flow system is studied by taking into account the lateral interaction with spatial defects. For a random defects distribution, if the vehicles velocities are weakly correlated, the traffic phases can be predicted by considering the corresponding inflow and outflow functions. Conversely, if the vehicles velocities are strongly correlated, a phase segregation appears inside the system's bulk which induces the maximum current appearance. Such velocity correlation depends mainly on the defects densities and the probabilities of lateral deceleration. However, for a compact defects distribution, the traffic phases are predictable by using the inflow in the system beginning, the inflow entering the defects zone and the outflow function.

"A Match Made...Online?" The Effects of User-Generated Online Dater Profile Types (Free-Spirited Versus Uptight) on Other Users' Perception of Trustworthiness, Interpersonal Attraction, and Personality.

PubMed

Jin, Seunga Venus; Martin, Cassie

2015-06-01

This study tested the effects of an online dater's profile type (open/free-spirited vs. traditional/uptight) on people's perception of the dater's trustworthiness, interpersonal attraction, and Big Five personality traits (agreeableness, conscientiousness, neuroticism, openness, and extraversion). Interpersonal deception theory, theories of attraction, and source credibility model inform this research, providing a theoretical foundation for the proposed research questions and hypothesis. This research employed a simple two-group comparison experiment (open/free-spirited dater profile vs. traditional/uptight dater profile). Participants were randomly assigned to view either open or traditional profiles, and asked about their perception of the target dater. Results indicated a significant causal effect of user-generated online dater profile types on the dependent variables (perceived trustworthiness, interpersonal attraction, and Big Five personality traits) as well as a significant mediating effect of perceived trustworthiness. This study provided unique and necessary information on self-presentation and other perception in the online dating context, with the aim of helping theorists, online daters, and managers of online dating sites further their understandings of this novel and exciting romantic frontier.

Secure communications using quantum cryptography

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hughes, R.J.; Buttler, W.T.; Kwiat, P.G.

1997-08-01

The secure distribution of the secret random bit sequences known as {open_quotes}key{close_quotes} material, is an essential precursor to their use for the encryption and decryption of confidential communications. Quantum cryptography is an emerging technology for secure key distribution with single-photon transmissions, nor evade detection (eavesdropping raises the key error rate above a threshold value). We have developed experimental quantum cryptography systems based on the transmission of non-orthogonal single-photon states to generate shared key material over multi-kilometer optical fiber paths and over line-of-sight links. In both cases, key material is built up using the transmission of a single-photon per bit ofmore » an initial secret random sequence. A quantum-mechanically random subset of this sequence is identified, becoming the key material after a data reconciliation stage with the sender. In our optical fiber experiment we have performed quantum key distribution over 24-km of underground optical fiber using single-photon interference states, demonstrating that secure, real-time key generation over {open_quotes}open{close_quotes} multi-km node-to-node optical fiber communications links is possible. We have also constructed a quantum key distribution system for free-space, line-of-sight transmission using single-photon polarization states, which is currently undergoing laboratory testing. 7 figs.« less

Randomized open-label trial of baclofen for relapse prevention in alcohol dependence.

PubMed

Gupta, Manushree; Verma, Pankaj; Rastogi, Rajesh; Arora, Sheetal; Elwadhi, Deeksha

2017-05-01

Alcohol dependence is a progressive chronic disorder characterized by narrowing of the drinking repertoire, salience of drinking, tolerance and withdrawal phenomenon, compulsion to drink, and frequent relapses. Baclofen has been shown to promote abstinence, to reduce craving, and to reduce anxiety in alcohol-dependent individuals, and it promises to be a useful agent, although clinical data are limited at present. The current study aimed to test the utility of baclofen, a GABA agonist, in improving the relapse rates in alcohol-dependent subjects. A total of 122 alcohol-dependent subjects were randomized into two groups. Groups were administered baclofen (30 mg/day) or benfothiamine (a nutritional supplement) using an open label design. Both groups received brief motivational intervention. Subjects were assessed at 0, 2, 4, 8, and 12 weeks for the primary outcome measures: time to first relapse, heavy drinking days, cumulative abstinence duration, and craving (measured by the Obsessive Compulsive Drinking Scale (OCDS)). Seventy-two participants received baclofen, and 50 received benfothiamine. Participants receiving baclofen remained abstinent for significantly more days than the benfothiamine group (p < 0.05). The percentage of heavy drinking days was significantly lower in the baclofen group (p = 0.001). Craving and anxiety scores (Hamilton Anxiety Rating Scale) were also significantly decreased in the baclofen group relative to the control group (p = 0.001). Time to first relapse was similar in both groups. In this open-label trial, alcohol-dependent participants receiving baclofen showed significant improvements in drinking outcomes compared with participants receiving benfothiamine. This study provides further evidence that baclofen is useful for the treatment of alcohol dependence.

A prospective, randomized, open-label study comparing the efficacy and safety of preprandial and prandial insulin in combination with acarbose in elderly, insulin-requiring patients with type 2 diabetes mellitus.

PubMed

Yang, Guang; Li, Chunlin; Gong, Yanping; Li, Jian; Cheng, Xiaoling; Tian, Hui

2013-06-01

By delaying absorption of carbohydrates, acarbose can reduce preprandial hyperglycemia and delay the emergence of postprandial hyperglycemia. To evaluate whether acarbose can shorten the desirable time interval between insulin injection and meals, 60 elderly (≥60 years) patients with unsatisfactorily controlled type 2 diabetes mellitus despite insulin use were enrolled in a randomized, open-label study of 16 weeks' duration. Two groups (n=20 each) were randomized to receive isophane protamine biosynthetic human insulin 70/30 injections twice daily 30 min before meals plus acarbose 50 mg once daily (Group A) or three times daily (Group B) before meals, whereas the third group (n=20) received isophane protamine biosynthetic human insulin 70/30 injections twice daily immediately before meals plus acarbose 50 mg three times daily before meals (Group C). The required insulin dosage at study end was significantly less in Groups B and C than in Group A. Both continuous glucose monitoring data and the patients' self-monitoring data indicated that blood glucose variability parameters were significantly improved in Groups B and C in comparison with Group A, but there were no significant differences between Groups B and C. The incidence of hypoglycemia was low in all three groups. The absence of a significant difference in glucose variability between Groups B and C suggests that the addition of acarbose permitted adjustment of the insulin administration time from 30 min before meals to immediately before meals-which may be more convenient for patients-without affecting glycemic control.

A Randomized Controlled Open-Label Pilot Study of Simvastatin Addition to Whole-Brain Radiation Therapy in Patients With Brain Metastases.

PubMed

El-Hamamsy, Manal; Elwakil, Hesham; Saad, Amr S; Shawki, May A

2016-10-27

Statins have been reported to have a potential radiosensitizing effect that has not been evaluated in clinical trials. The aim of this study was to evaluate the efficacy and safety of simvastatin in addition to whole-brain radiation therapy (WBRT) in patients with brain metastases (BM). A prospective randomized, controlled, open-label pilot study was conducted on 50 Egyptian patients with BM who were randomly assigned to receive 30-Gy WBRT (control group: 25 patients) or 30 Gy WBRT + simvastatin 80 mg/day for the WBRT period (simvastatin group: 25 patients). The primary outcome was radiological response at 4 weeks after WBRT. Secondary outcomes were 1-year progression-free survival (PFS), 1-year overall survival (OS), and health-related quality of life (HRQL) that was assessed using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and its brain module (BN-20), at baseline, after WBRT, and 4 weeks after WBRT. The addition of simvastatin was tolerated. Twenty-one patients were not evaluated for radiological response because of death (n = 16), noncompliance to follow-up (n = 4), and clinical deterioration (n = 1). Response rates were 60% and 78.6% (p = 0.427), 1-year PFS rates were 5.2% and 17.7% (p = 0.392), and 1-year OS rates were 12% and 8% (p = 0.880) for the control group and simvastatin group, respectively. Nonsignificant differences were found between the two arms regarding HRQL scales. The addition of simvastatin 80 mg/day did not improve the clinical outcomes of patients with BM receiving WBRT.

Feasibility of a cardiologist-only approach to sedation for electrical cardioversion of atrial fibrillation: a randomized, open-blinded, prospective study.

PubMed

Guerra, Federico; Pavoni, Ilaria; Romandini, Andrea; Baldetti, Luca; Matassini, Maria Vittoria; Brambatti, Michela; Luzi, Mario; Pupita, Giuseppe; Capucci, Alessandro

2014-10-20

Sedation with propofol should be administered by personnel trained in advanced airway management. To overcome this limitation, the use of short acting benzodiazepines by cardiologists spread widely, causing concerns about the safety of this procedure in the absence of anesthesiology assistance. The aim of the study was to compare feasibility of a cardiologist-only approach with an anesthesiologist-assisted sedation protocol during elective direct-current cardioversion (DCC) of persistent atrial fibrillation (AF). This prospective, open-blinded, randomized study included 204 patients, which were admitted for scheduled cardioversion of persistent AF, and randomized in a 1:1 fashion to either propofol or midazolam treatment arm. Patients in the propofol group underwent DCC with anesthesiologist assistance, while patients in the midazolam group saw the cardiologist as the only responsible for both sedation and DCC. Twenty-three adverse events occurred: 13 in the propofol group and 10 in the midazolam group (p=NS). Most of them were related to bradyarrhythmias and respiratory depressions. There was no need of intubation or other advanced resuscitation techniques in any of these patients. No differences were found regarding procedure tolerability and safety endpoints between the two groups. DCC procedures with anesthesiology support were burdened by higher delay from scheduled time and higher costs. Sedation with midazolam administered by cardiologist-only appears to be as safe as sedation with propofol and anesthesiologist assistance. Adverse events were few in both groups and easily handled by the cardiologist alone. A cardiologist-only approach to sedation provides less procedural delay, thus being easier to schedule and correlated with fewer costs. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

A randomized, open-label study to evaluate the safety and pharmacokinetics of human hepatitis C immune globulin (Civacir) in liver transplant recipients.

PubMed

Davis, Gary L; Nelson, David R; Terrault, Norah; Pruett, Timothy L; Schiano, Thomas D; Fletcher, Courtney V; Sapan, Christine V; Riser, Laura N; Li, Yufeng; Whitley, Richard J; Gnann, John W

2005-08-01

Chronic hepatitis C is the most common indication for liver transplantation, but viral recurrence is universal and progressive graft injury occurs in most recipients. Our aim was to assess the safety, pharmacokinetics (PK), and antiviral effects of high doses of a human hepatitis C antibody enriched immune globulin product (HCIG) in patients undergoing liver transplantation for chronic hepatitis C. This was a multicenter, randomized, open-label, controlled trial conducted at 4 transplant centers in the United States. A total of 18 patients with chronic hepatitis C, who underwent liver transplantation, were randomized to receive low-dose HCIG (75 mg/kg) or high-dose HCIG (200 mg/kg), or no treatment. A total of 17 infusions of HCIG were administered in each treated patient over 14 weeks using a time-dependent dosing strategy based on the PK of anti-hepatitis B immune globulin in liver transplant recipients. Hepatitis C virus levels, liver enzymes, and liver biopsies were obtained serially throughout the study period. PK profiles of HCV antibodies were determined on days 4, 10, and 98. HCIG infusions were safe and tolerated. The infusion rate could not be maximized because of symptoms for 18% to 30% of the doses. The half-life of HCIG was extremely short immediately after transplantation but was gradually prolonged. In the high-dose group, serum alanine aminotransferase (ALT) levels normalized in most subjects and no patient developed hepatic fibrosis. However, serum HCV RNA levels were not suppressed at either dose. In conclusion, HCIG, an anti-HCV enriched immune globulin product, appears to be safe in patients with chronic hepatitis C undergoing liver transplantation. Further studies are required to determine whether the drug has beneficial effects in this group of patients.

Open ear hearing aids in tinnitus therapy: An efficacy comparison with sound generators.

PubMed

Parazzini, Marta; Del Bo, Luca; Jastreboff, Margaret; Tognola, Gabriella; Ravazzani, Paolo

2011-08-01

This study aimed to compare the effectiveness of tinnitus retraining therapy (TRT) with sound generators or with open ear hearing aids in the rehabilitation of tinnitus for a group of subjects who, according to Jastreboff categories, can be treated with both approaches to sound therapy (borderline of Category 1 and 2). This study was a prospective data collection with a parallel-group design which entailed that each subject was randomly assigned to one of the two treatments group: half of the subjects were fitted binaurally with sound generators, and the other half with open ear hearing aids. Both groups received the same educational counselling sessions. Ninety-one subjects passed the screening criteria and were enrolled into the study. Structured interviews, with a variety of measures evaluated through the use of visual-analog scales and the tinnitus handicap inventory self-administered questionnaire, were performed before the therapy and at 3, 6, and 12 months during the therapy. Data showed a highly significant improvement in both tinnitus treatments starting from the first three months and up to one year of therapy, with a progressive and statistically significant decrease in the disability every three months. TRT was equally effective with sound generator or open ear hearing aids: they gave basically identical, statistically indistinguishable results.

Parsing Citations in Biomedical Articles Using Conditional Random Fields

PubMed Central

Zhang, Qing; Cao, Yong-Gang; Yu, Hong

2011-01-01

Citations are used ubiquitously in biomedical full-text articles and play an important role for representing both the rhetorical structure and the semantic content of the articles. As a result, text mining systems will significantly benefit from a tool that automatically extracts the content of a citation. In this study, we applied the supervised machine-learning algorithms Conditional Random Fields (CRFs) to automatically parse a citation into its fields (e.g., Author, Title, Journal, and Year). With a subset of html format open-access PubMed Central articles, we report an overall 97.95% F1-score. The citation parser can be accessed at: http://www.cs.uwm.edu/~qing/projects/cithit/index.html. PMID:21419403

Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period.

PubMed

Kadowaki, Takashi; Kondo, Kazuoki; Sasaki, Noriyuki; Miyayama, Kyoko; Yokota, Shoko; Terata, Ryuji; Gouda, Maki

2017-09-01

To assess the efficacy and safety of teneligliptin as add-on to insulin monotherapy in patients with type 2 diabetes mellitus (T2DM). In a 16-week, double-blind period, 148 Japanese T2DM patients with inadequate glycemic control with insulin and diet/exercise therapies were randomized to placebo or teneligliptin 20 mg. In a subsequent 36-week, open-label period, all patients received teneligliptin once daily. The primary outcome measure was change in HbA1c at the end of the double-blind period. The difference between placebo and teneligliptin in change in HbA1c in the double-blind period (least squares mean ± SE) was -0.80% ± 0.11%; teneligliptin was superior (ANCOVA, P < 0.001). The HbA1c-lowering effect of teneligliptin was maintained throughout the open-label period. The incidence of adverse events was 53.5% with placebo and 44.2% with teneligliptin in the double-blind period, 66.7% in the placebo/teneligliptin group in the open-label period, and 77.9% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. The incidence of hypoglycemic symptoms was 11.1% in the placebo/teneligliptin group in the open-label period and 27.3% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. Teneligliptin was effective and well tolerated in Japanese T2DM patients with inadequate glycemic control. NCT02081599.

Classification and valuation of postoperative complications in a randomized trial of open versus laparoscopic ventral herniorrhaphy.

PubMed

Kaafarani, H M A; Hur, K; Campasano, M; Reda, D J; Itani, K M F

2010-06-01

Generic instruments used for the valuation of health states (e.g., EuroQol) often lack sensitivity to notable differences that are relevant to particular diseases or interventions. We developed a valuation methodology specifically for complications following ventral incisional herniorrhaphy (VIH). Between 2004 and 2006, 146 patients were prospectively randomized to undergo laparoscopic (n = 73) or open (n = 73) VIH. The primary outcome of the trial was complications at 8 weeks. A three-step methodology was used to assign severity weights to complications. First, each complication was graded using the Clavien classification. Second, five reviewers were asked to independently and directly rate their perception of the severity of each class using a non-categorized visual analog scale. Zero represented an uncomplicated postoperative course, while 100 represented postoperative death. Third, the median, lowest, and highest values assigned to each class of complications were used to derive weighted complication scores for open and laparoscopic VIH. Open VIH had more complications than laparoscopic VIH (47.9 vs. 31.5%, respectively; P = 0.026). However, complications of laparoscopic VIH were more severe than those of open VIH. Non-parametric analysis revealed a statistically higher weighted complication score for open VIH (interquartile range: 0-20 for open vs. 0-10 for laparoscopic; P = 0.049). In the sensitivity analysis, similar results were obtained using the median, highest, and lowest weights. We describe a new methodology for the valuation of complications following VIH that allows a direct outcome comparison of procedures with different complication profiles. Further testing of the validity, reliability, and generalizability of this method is warranted.

Development of fetal yawn compared with non-yawn mouth openings from 24-36 weeks gestation.

PubMed

Reissland, Nadja; Francis, Brian; Mason, James

2012-01-01

Although some research suggests that fetuses yawn, others disagree arguing that is it simple mouth opening. Furthermore there is no developmental account of fetal yawning compared with simple mouth opening. The aim of the present study was to establish in a repeated measures design the development of fetal yawning compared with simple mouth opening. Video recordings were made of the fetal face and upper torso visualized by means of 4D full frontal or facial profile ultrasound recordings. Fifteen healthy fetuses were scanned four times at 24, 28, 32 and 36 weeks gestation. Yawning was distinguished from non-yawning in terms of the length of time it took to reach the apex of the mouth stretch, with yawns being defined as more than 50% of the total time observed. To assess changes in frequency, a Poisson mixed effects model was fitted to the count of number of yawn and simple mouth opening events with age and gender as fixed effects, and person as a random effect. For both yawns and simple mouth openings a smooth varying age effect was significant. The number of yawns observed declined with age from 28 weeks gestation, whereas simple mouth openings were less frequent and the decline was observed from 24 weeks. Gender was not significant either for yawn and simple mouth openings. Yawning can be reliably distinguished from other forms of mouth opening with the potential of using yawning as an index of fetal healthy development.

Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial.

PubMed

Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

2014-12-01

Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care.

Comparative efficacy trial of cupping and serkangabin versus conventional therapy of migraine headaches: A randomized, open-label, comparative efficacy trial

PubMed Central

Firoozabadi, Mohammad Dehghani; Navabzadeh, Maryam; Roudsari, Mohammad Khodashenas; Zahmatkash, Mohsen

2014-01-01

Background: Migraine headaches are the most common acute and recurrent headaches. Current treatment of a migraine headache consists of multiple medications for control and prevention of recurrent attacks. Global emergence of alternative medicine led us to examine the efficacy of cupping therapy plus serkangabin syrup in the treatment of migraine headaches. Materials and Methods: This study was a randomized, controlled, open-label, comparative efficacy trial. We randomly assigned patients with migraine into cupping therapy plus serkangabin group (30 patients) and conventional treatment group (30 patients). An investigator assessed the severity of headache, frequency of attacks in a week and duration of attacks per hour in 5 visits (at the end of 2 weeks, 1, 3 and 6 months). Generalized estimating equations approach was used to analyze repeated measures data to compare outcomes in both groups. Results: Average age for cupping therapy group and conventional treatment group were 31.7 (±7.6) and 32.6 (±12.7) years, respectively (P = 0.45). After treatment for 2 weeks; and 1, 3 and 6 months, severity of headache (P = 0.80), frequency of migraine attacks (P = 0.63) and duration of attacks per hours (P = 0.48) were similar in conventional and cupping groups but these symptoms were decreased in each group during the study (P < 0.001). Conclusion: There was no significant difference between cupping plus serkangabin therapy and conventional treatment in the treatment and prophylaxis of migraine. The alternative therapy may be used in cases of drug intolerance, no medication response, and in primary care. PMID:25709653

Investigating the Contextual Interference Effect Using Combination Sports Skills in Open and Closed Skill Environments

PubMed Central

Cheong, Jadeera P.G.; Lay, Brendan; Razman, Rizal

2016-01-01

This study attempted to present conditions that were closer to the real-world setting of team sports. The primary purpose was to examine the effects of blocked, random and game-based training practice schedules on the learning of the field hockey trap, close dribble and push pass that were practiced in combination. The secondary purpose was to investigate the effects of predictability of the environment on the learning of field hockey sport skills according to different practice schedules. A game-based training protocol represented a form of random practice in an unstable environment and was compared against a blocked and a traditional random practice schedule. In general, all groups improved dribble and push accuracy performance during the acquisition phase when assessed in a closed environment. In the retention phase, there were no differences between the three groups. When assessed in an open skills environment, all groups improved their percentage of successful executions for trapping and passing execution, and improved total number of attempts and total number of successful executions for both dribbling and shooting execution. Between-group differences were detected for dribbling execution with the game-based group scoring a higher number of dribbling successes. The CI effect did not emerge when practicing and assessing multiple sport skills in a closed skill environment, even when the skills were practiced in combination. However, when skill assessment was conducted in a real-world situation, there appeared to be some support for the CI effect. Key points The contextual interference effect was not supported when practicing several skills in combination when the sports skills were assessed in a closed skill environment. There appeared to be some support for the contextual interference effect when sports skills were assessed in an open skill environment, which were similar to a real game situation. A game-based training schedule can be used as an alternative practice schedule as it displayed superior learning compared to a blocked practice schedule when assessed by the game performance test (real-world setting). The game-based training schedule also matched the blocked and random practice schedules in the other tests. PMID:26957940

Investigating the Contextual Interference Effect Using Combination Sports Skills in Open and Closed Skill Environments.

PubMed

Cheong, Jadeera P G; Lay, Brendan; Razman, Rizal

2016-03-01

This study attempted to present conditions that were closer to the real-world setting of team sports. The primary purpose was to examine the effects of blocked, random and game-based training practice schedules on the learning of the field hockey trap, close dribble and push pass that were practiced in combination. The secondary purpose was to investigate the effects of predictability of the environment on the learning of field hockey sport skills according to different practice schedules. A game-based training protocol represented a form of random practice in an unstable environment and was compared against a blocked and a traditional random practice schedule. In general, all groups improved dribble and push accuracy performance during the acquisition phase when assessed in a closed environment. In the retention phase, there were no differences between the three groups. When assessed in an open skills environment, all groups improved their percentage of successful executions for trapping and passing execution, and improved total number of attempts and total number of successful executions for both dribbling and shooting execution. Between-group differences were detected for dribbling execution with the game-based group scoring a higher number of dribbling successes. The CI effect did not emerge when practicing and assessing multiple sport skills in a closed skill environment, even when the skills were practiced in combination. However, when skill assessment was conducted in a real-world situation, there appeared to be some support for the CI effect. Key pointsThe contextual interference effect was not supported when practicing several skills in combination when the sports skills were assessed in a closed skill environment.There appeared to be some support for the contextual interference effect when sports skills were assessed in an open skill environment, which were similar to a real game situation.A game-based training schedule can be used as an alternative practice schedule as it displayed superior learning compared to a blocked practice schedule when assessed by the game performance test (real-world setting). The game-based training schedule also matched the blocked and random practice schedules in the other tests.

[NASA/DOD Aerospace Knowledge Diffusion Research Project. Report 1, part 2:] Technical communications in aeronautics: Results of an exploratory study

NASA Technical Reports Server (NTRS)

Pinelli, Thomas E.; Glassman, Myron; Oliu, Walter E.; Barclay, Rebecca O.

1989-01-01

A study was undertaken that explored several aspects of technical communications in aeronautics. The study, which utilized survey research in the form of a self-administered questionnaire, was sent to 2,000 randomly selected members of the American Institute of Aeronautics and Astronautics. Six hundred and six usable questionnaires (30.3 percent) were received by the established cut off date. Part 2 of this study lists appendices to part 1, including survey instrument, aggregate totals, cross tabulations, and open-ended comments.

A Cluster-Randomized Trial of Insecticide-Treated Curtains for Dengue Vector Control in Thailand

PubMed Central

Lenhart, Audrey; Trongtokit, Yuwadee; Alexander, Neal; Apiwathnasorn, Chamnarn; Satimai, Wichai; Vanlerberghe, Veerle; Van der Stuyft, Patrick; McCall, Philip J.

2013-01-01

The efficacy of insecticide-treated window curtains (ITCs) for dengue vector control was evaluated in Thailand in a cluster-randomized controlled trial. A total of 2,037 houses in 26 clusters was randomized to receive the intervention or act as control (no treatment). Entomological surveys measured Aedes infestations (Breteau index, house index, container index, and pupae per person index) and oviposition indices (mean numbers of eggs laid in oviposition traps) immediately before and after intervention, and at 3-month intervals over 12 months. There were no consistent statistically significant differences in entomological indices between intervention and control clusters, although oviposition indices were lower (P < 0.01) in ITC clusters during the wet season. It is possible that the open housing structures in the study reduced the likelihood of mosquitoes making contact with ITCs. ITCs deployed in a region where this house design is common may be unsuitable for dengue vector control. PMID:23166195

Transfer of preterm infants from incubator to open cot at lower versus higher body weight.

PubMed

New, K; Flenady, V; Davies, M W

2004-01-01

The use of incubators in helping to maintain a thermoneutral environment for preterm infants has become routine practice in neonatal nurseries. As one of the key criteria for discharging preterm infants from nurseries is their ability to maintain temperature, the infant will need to make the transition from incubator to open cot at some time before discharge. The timing of this transition is important because when an infant is challenged by cold, the infant attempts to increase its heat production to maintain body temperature. The increase in energy expenditure may affect weight gain. The practice of transferring infants from incubators to open cots usually occurs once a weight of around 1700-1800 g has been reached; however, this practice varies widely between neonatal units. This preferred weight mark appears to be largely based on tradition or the personal experience of clinicians, with little consideration of the infant's weight or gestational age at birth. The main objective was to assess the effects on weight gain and temperature control of a policy of transferring preterm infants from incubator to open cot at lower versus higher body weight. Searches were undertaken of MEDLINE from June 2003 back to 1966, CINAHL from June 2003 back to 1987 and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2003). The title and abstract of each retrieved study were examined to assess eligibility. If there was uncertainty, the full paper was examined. Trials in which preterm infants were randomly allocated to a policy of transfer from incubators to open cots at a lower body weight versus at a higher body weight. Quality assessments and data extraction for included trials were conducted independently by the reviewers. Data for individual trial results were analysed using relative risk (RR) and mean difference (MD). Results are presented with 95% confidence intervals (CI). Due to insufficient data, meta-analysis could not be undertaken. Four studies were identified as potentially eligible for inclusion in this review. Two studies were excluded as random allocation to the exposure was not employed. One study is pending, awaiting additional information from the authors. Therefore, one study involving 60 preterm infants, employing a matched-pairs design, which compared the transfer of infants to open cots at 1700 g versus 1800 g, is included in this review. Only two outcomes could be included from this study; return to incubator and daily weight gain. No statistically significant difference was shown for either return to incubator (RR 2.00, 95% CI 0.40 to 10.11) or daily weight gain [MD 4.00 g/day (95% CI -5.23, 13.23)]. Due to small numbers, effects on clinically important outcomes could not be adequately assessed. There is currently little evidence from randomised trials to inform practice on the preferred weight for transferring preterm infants from incubators to open cots. There is a need for larger randomised controlled trials to address this deficiency.

Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials.

PubMed

Melin, Eva O; Svensson, Ralph; Gustavsson, Sven-Åke; Winberg, Agneta; Denward-Olah, Ewa; Landin-Olsson, Mona; Thulesius, Hans O

2016-04-27

Depression is linked with alexithymia, anxiety, high HbA1c concentrations, disturbances of cortisol secretion, increased prevalence of diabetes complications and all-cause mortality. The psycho-educational method 'affect school with script analysis' and the mind-body therapy 'basic body awareness treatment' will be trialled in patients with diabetes, high HbA1c concentrations and psychological symptoms. The primary outcome measure is change in symptoms of depression. Secondary outcome measures are changes in HbA1c concentrations, midnight salivary cortisol concentration, symptoms of alexithymia, anxiety, self-image measures, use of antidepressants, incidence of diabetes complications and mortality. Two studies will be performed. Study I is an open-labeled parallel-group study with a two-arm randomized controlled trial design. Patients are randomized to either affect school with script analysis or to basic body awareness treatment. According to power calculations, 64 persons are required in each intervention arm at the last follow-up session. Patients with type 1 or type 2 diabetes were recruited from one hospital diabetes outpatient clinic in 2009. The trial will be completed in 2016. Study II is a multicentre open-labeled parallel-group three-arm randomized controlled trial. Patients will be randomized to affect school with script analysis, to basic body awareness treatment, or to treatment as usual. Power calculations show that 70 persons are required in each arm at the last follow-up session. Patients with type 2 diabetes will be recruited from primary care. This study will start in 2016 and finish in 2023. For both studies, the inclusion criteria are: HbA1c concentration ≥62.5 mmol/mol; depression, alexithymia, anxiety or a negative self-image; age 18-59 years; and diabetes duration ≥1 year. The exclusion criteria are pregnancy, severe comorbidities, cognitive deficiencies or inadequate Swedish. Depression, anxiety, alexithymia and self-image are assessed using self-report instruments. HbA1c concentration, midnight salivary cortisol concentration, blood pressure, serum lipid concentrations and anthropometrics are measured. Data are collected from computerized medical records and the Swedish national diabetes and causes of death registers. Whether the "affect school with script analysis" will reduce psychological symptoms, increase emotional awareness and improve diabetes related factors will be tried, and compared to "basic body awareness treatment" and treatment as usual. ClinicalTrials.gov: NCT01714986.

Random fiber lasers based on artificially controlled backscattering fibers

NASA Astrophysics Data System (ADS)

Chen, Daru; Wang, Xiaoliang; She, Lijuan; Qiang, Zexuan; Yu, Zhangwei

2017-10-01

The random fiber laser (RFL) which is a milestone in laser physics and nonlinear optics, has attracted considerable attention recently. Most previous RFLs are based on distributed feedback of Rayleigh scattering amplified through stimulated Raman/Brillouin scattering effect in single mode fibers, which required long-distance (tens of kilometers) single mode fibers and high threshold up to watt-level due to the extremely small Rayleigh scattering coefficient of the fiber. We proposed and demonstrated a half-open cavity RFL based on a segment of a artificially controlled backscattering SMF(ACB-SMF) with a length of 210m, 310m or 390m. A fiber Bragg grating with the central wavelength of 1530nm and a segment of ACB-SMF forms the half-open cavity. The proposed RFL achieves the threshold of 25mW, 30mW and 30mW, respectively. Random lasing at the wavelength of 1530nm and the extinction ratio of 50dB is achieved when a segment of 5m EDF is pumped by a 980nm LD in the RFL. Another half-open cavity RFL based on a segment of a artificially controlled backscattering EDF(ACBS-EDF) is also demonstrated without an ACB-SMF. The 3m ACB-EDF is fabricated by using the femtosecond laser with pulse energy of 0.34mJ which introduces about 50 reflectors in the EDF. Random lasing at the wavelength of 1530nm is achieved with the output power of 7.5mW and the efficiency of 1.88%. Two novel RFLs with much short cavities have been achieved with low threshold and high efficiency.

Repeats of base oligomers as the primordial coding sequences of the primeval earth and their vestiges in modern genes.

PubMed

Ohno, S

1984-01-01

Three outstanding properties uniquely qualify repeats of base oligomers as the primordial coding sequences of all polypeptide chains. First, when compared with randomly generated base sequences in general, they are more likely to have long open reading frames. Second, periodical polypeptide chains specified by such repeats are more likely to assume either alpha-helical or beta-sheet secondary structures than are polypeptide chains of random sequence. Third, provided that the number of bases in the oligomeric unit is not a multiple of 3, these internally repetitious coding sequences are impervious to randomly sustained base substitutions, deletions, and insertions. This is because the recurring periodicity of their polypeptide chains is given by three consecutive copies of the oligomeric unit translated in three different reading frames. Accordingly, when one reading frame is open, the other two are automatically open as well, all three being capable of coding for polypeptide chains of identical periodicity. Under this circumstance, a frame shift due to the deletion or insertion of a number of bases that is not a multiple of 3 fails to alter the down-stream amino acid sequence, and even a base change causing premature chain-termination can silence only one of the three potential coding units. Newly arisen coding sequences in modern organisms are oligomeric repeats, and most of the older genes retain various vestiges of their original internal repetitions. Some of the genes (e.g., oncogenes) have even inherited the property of being impervious to randomly sustained base changes.

Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial.

PubMed

Rossignol, Patrick; Dorval, Marc; Fay, Renaud; Ros, Joan Fort; Loughraieb, Nathalie; Moureau, Frédérique; Laville, Maurice

2013-06-01

Anticoagulation for chronic dialysis patients with contraindications to heparin administration is challenging. Current guidelines state that in patients with increased bleeding risks, strategies that can induce systemic anticoagulation should be avoided. Heparin-free dialysis using intermittent saline flushes is widely adopted as the method of choice for patients at risk of bleeding, although on-line blood predilution may also be used. A new dialyzer, Evodial (Gambro, Lund, Sweden), is grafted with unfractionated heparin during the manufacturing process and may allow safe and efficient heparin-free hemodialysis sessions. In the present trial, Evodial was compared to standard care with either saline flushes or blood predilution. The HepZero study is the first international (seven countries), multicenter (10 centers), randomized, controlled, open-label, non-inferiority (and if applicable subsequently, superiority) trial with two parallel groups, comprising 252 end-stage renal disease patients treated by maintenance hemodialysis for at least 3 months and requiring heparin-free dialysis treatments. Patients will be treated during a maximum of three heparin-free dialysis treatments with either saline flushes or blood predilution (control group), or Evodial. The first heparin-free dialysis treatment will be considered successful when there is: no complete occlusion of air traps or dialyzer rendering dialysis impossible; no additional saline flushes to prevent clotting; no change of dialyzer or blood lines because of clotting; and no premature termination (early rinse-back) because of clotting.The primary objectives of the study are to determine the effectiveness of the Evodial dialyzer, compared with standard care in terms of successful treatments during the first heparin-free dialysis. If the non-inferiority of Evodial is demonstrated then the superiority of Evodial over standard care will be tested. The HepZero study results may have major clinical implications for patient care. ClinicalTrials.gov NCT01318486.

Dolutegravir versus placebo in subjects harbouring HIV-1 with integrase inhibitor resistance associated substitutions: 48-week results from VIKING-4, a randomized study.

PubMed

Akil, Bisher; Blick, Gary; Hagins, Debbie P; Ramgopal, Moti N; Richmond, Gary J; Samuel, Rafik M; Givens, Naomi; Vavro, Cindy; Song, Ivy H; Wynne, Brian; Ait-Khaled, Mounir

2015-01-01

The Phase III VIKING-3 study demonstrated that dolutegravir (DTG) 50 mg twice daily was efficacious in antiretroviral therapy (ART)-experienced subjects harbouring raltegravir- and/or elvitegravir-resistant HIV-1. VIKING-4 (ING116529) included a placebo-controlled 7-day monotherapy phase to demonstrate that short-term antiviral activity was attributable to DTG. VIKING-4 is a Phase III randomized, double-blind study in therapy-experienced adults with integrase inhibitor (INI)-resistant virus randomized to DTG 50 mg twice daily or placebo while continuing their failing regimen (without raltegravir or elvitegravir) for 7 days (clinicaltrials.gov identifier NCT01568892). At day 8, all subjects switched to open-label DTG 50 mg twice daily and optimized background therapy including ≥1 fully active drug. The primary end point was change from baseline in plasma HIV-1 RNA at day 8. The study population (n=30) was highly ART-experienced with advanced HIV disease. Patients had extensive baseline resistance to all approved antiretroviral classes. Adjusted mean change in HIV-1 RNA at day 8 was 
-1.06 log10 copies/ml for the DTG arm and 0.10 log10 copies/ml for the placebo arm (treatment difference -1.16 log10 copies/ml [-1.52, -0.80]; P<0.001). Overall, 47% and 57% of subjects had plasma HIV-1 RNA <50 and <400 copies/ml at week 24, and 40% and 53% at week 48, respectively. No discontinuations due to drug-related adverse events occurred in the study. The observed day 8 antiviral activity in this highly treatment-experienced population with INI-resistant HIV-1 was attributable to DTG. Longer-term efficacy (after considering baseline ART resistance) and safety during the open-label phase were in-line with the results of the larger VIKING-3 study.

Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

PubMed Central

2012-01-01

Background Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. Methods We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. Results Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled. Conclusions The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage. Trial registration Phase I/II trial, NCT00598130 PMID:23137020

Therapeutic effect of increased openness: Investigating mechanism of action in MDMA-assisted psychotherapy.

PubMed

Wagner, Mark T; Mithoefer, Michael C; Mithoefer, Ann T; MacAulay, Rebecca K; Jerome, Lisa; Yazar-Klosinski, Berra; Doblin, Rick

2017-08-01

A growing body of research suggests that traumatic events lead to persisting personality change characterized by increased neuroticism. Relevantly, enduring improvements in Post-Traumatic Stress Disorder (PTSD) symptoms have been found in response to 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy. There is evidence that lasting changes in the personality feature of "openness" occur in response to hallucinogens, and that this may potentially act as a therapeutic mechanism of change. The present study investigated whether heightened Openness and decreased Neuroticism served as a mechanism of change within a randomized trial of MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD. The Clinician-Administered PTSD Scale (CAPS) Global Scores and NEO PI-R Personality Inventory (NEO) Openness and Neuroticism Scales served as outcome measures. Results indicated that changes in Openness but not Neuroticism played a moderating role in the relationship between reduced PTSD symptoms and MDMA treatment. Following MDMA-assisted psychotherapy, increased Openness and decreased Neuroticism when comparing baseline personality traits with long-term follow-up traits also were found. These preliminary findings suggest that the effect of MDMA-assisted psychotherapy extends beyond specific PTSD symptomatology and fundamentally alters personality structure, resulting in long-term persisting personality change. Results are discussed in terms of possible mechanisms of psychotherapeutic change.

Role of decaying logs and other organic seedbeds in natural regeneration of Hawaiian forest species on abandoned montane pasture

Treesearch

Paul G. Scowcroft

1992-01-01

Natural regeneration is one mechanism by which native mixed-species forests become reestablished on abandoned pasture. This study was done to determine patterns of and requirement for natural regeneration of native species in an open woodland after removal of cattle. Ten 50- by 50-m quadrats were randomly selected within a 16-ha exclosure located at 1,700-m elevation...

Association between open or closed reduction and avascular necrosis in developmental dysplasia of the hip: A PRISMA-compliant meta-analysis of observational studies.

PubMed

Wang, Ya-Jie; Yang, Fan; Wu, Qi-Jun; Pan, Shi-Nong; Li, Lian-Yong

2016-07-01

The risk of avascular necrosis of the femoral head (AVN) after treatment of developmental dysplasia of the hip is associated with the method of reduction. Some authors have suggested that open reduction is a risk factor for AVN; however, this is controversial. To our knowledge, a quantitative comparison of the incidence of AVN between closed and open reduction has not been conducted. Published studies were identified by searching PubMed, EMBASE, and the Cochrane Library up to May, 2015, focusing on the incidence of AVN after closed or open reduction for developmental dysplasia of the hip in children aged <3 years. Patients were age-matched who were treated by either closed or open reduction, but without pelvic or femoral osteotomy. Two authors independently assessed eligibility and abstracted data. Discrepancies were discussed and resolved by consensus. We pooled the odds ratios (ORs) and 95% confidence intervals (95%CIs) from individual studies using a random-effects model and evaluated heterogeneity and publication bias. Nine retrospective studies were included in this analysis. The pooled OR for comparing open reduction with closed reduction for all grades of AVN was 2.26 (95%CI = 1.21-4.22), with moderate heterogeneity (I = 44.7%, P = 0.107). The pooled OR for grades II to IV AVN was 2.46 (95%CI = 0.93-6.51), with high heterogeneity (I = 69.6%, P = 0.003). A significant association was also found for the further surgery between open and closed reduction, with a pooled OR of 0.30 (95%CI = 0.15-0.60) and moderate heterogeneity (I = 46.4%, P = 0.133). No evidence of publication bias or significant heterogeneity between subgroups was detected by meta-regression analyses. Findings from this meta-analysis suggest that open reduction is a risk factor for the development of AVN compared with closed treatment. Future studies are warranted to investigate how open reduction combined with pelvis and/or femoral osteotomy affects the incidence of AVN.

The continuous time random walk, still trendy: fifty-year history, state of art and outlook

NASA Astrophysics Data System (ADS)

Kutner, Ryszard; Masoliver, Jaume

2017-03-01

In this article we demonstrate the very inspiring role of the continuous-time random walk (CTRW) formalism, the numerous modifications permitted by its flexibility, its various applications, and the promising perspectives in the various fields of knowledge. A short review of significant achievements and possibilities is given. However, this review is still far from completeness. We focused on a pivotal role of CTRWs mainly in anomalous stochastic processes discovered in physics and beyond. This article plays the role of an extended announcement of the Eur. Phys. J. B Special Issue [http://epjb.epj.org/open-calls-for-papers/123-epj-b/1090-ctrw-50-years-on] containing articles which show incredible possibilities of the CTRWs. Contribution to the Topical Issue "Continuous Time Random Walk Still Trendy: Fifty-year History, Current State and Outlook", edited by Ryszard Kutner and Jaume Masoliver.

A randomized, open-label 3-way crossover study to investigate the relative bioavailability and bioequivalence of crushed sildenafil 20 mg tablets mixed with apple sauce, extemporaneously prepared suspension (EP), and intact sildenafil 20 mg tablets in healthy volunteers under fasting conditions.

PubMed

Gao, Xiang; Ndongo, Marie-Noella; Checchio, Tina M; Cook, Jack; Duncan, Barbara; LaBadie, Robert R

2015-01-01

The relative bioavailability and bioequivalence of 20-mg doses of a pediatric formulation of sildenafil extemporaneous preparation suspension (EP; 10 mg/mL), the sildenafil 20-mg intact tablet and the crushed sildenafil 20-mg tablet mixed with apple sauce were assessed in a single-dose, randomized, open-label, 3-way crossover study with 18 healthy adult volunteers. Blood samples were collected at predefined times and analyzed for sildenafil plasma concentrations. Natural log-transformed sildenafil pharmacokinetic parameters (Cmax , AUClast , and AUCinf ) were used to estimate relative bioavailability and construct 90% confidence intervals (CI) using a mixed-effects model. Bioequivalence was concluded among the three formulations with one exception, in which the EP suspension showed a 15% decrease in Cmax with a lower 90% CI of 76% compared with the intact tablet. The 15% decrease in sildenafil Cmax is not considered to be clinically relevant. Therefore, the EP suspension is considered to be an appropriate pediatric formulation. All 3 formulations were well tolerated in healthy adult volunteers. © 2014, The American College of Clinical Pharmacology.

Generating random numbers by means of nonlinear dynamic systems

NASA Astrophysics Data System (ADS)

Zang, Jiaqi; Hu, Haojie; Zhong, Juhua; Luo, Duanbin; Fang, Yi

2018-07-01

To introduce the randomness of a physical process to students, a chaotic pendulum experiment was opened in East China University of Science and Technology (ECUST) on the undergraduate level in the physics department. It was shown chaotic motion could be initiated through adjusting the operation of a chaotic pendulum. By using the data of the angular displacements of chaotic motion, random binary numerical arrays can be generated. To check the randomness of generated numerical arrays, the NIST Special Publication 800-20 method was adopted. As a result, it was found that all the random arrays which were generated by the chaotic motion could pass the validity criteria and some of them were even better than the quality of pseudo-random numbers generated by a computer. Through the experiments, it is demonstrated that chaotic pendulum can be used as an efficient mechanical facility in generating random numbers, and can be applied in teaching random motion to the students.

Open- and Closed-Skill Exercise Interventions Produce Different Neurocognitive Effects on Executive Functions in the Elderly: A 6-Month Randomized, Controlled Trial

PubMed Central

Tsai, Chia-Liang; Pan, Chien-Yu; Chen, Fu-Chen; Tseng, Yu-Ting

2017-01-01

This study aimed to explore the effects of open- and closed-skill exercise interventions on the neurocognitive performance of executive functions in the elderly. Sixty-four healthy elderly males were randomly assigned to either a closed-skill (bike riding or brisk walking/jogging, n = 22), open-skill (table tennis, n = 21), or control (n = 21) group. Various neuropsychological [e.g., accuracy rates (AR) and reaction time (RT)] and electrophysiological [e.g., event-related potential (ERP) P3 component] measures were assessed during a variant of the task-switching paradigm, as well as an N-back task at baseline and after either a 6-month exercise intervention or control period. The results showed that, when performing the task-switching paradigm, the two exercise groups relative to control group showed significantly faster RTs in the switch trials after the exercise intervention. However, the RT facilitation in the non-switch and switch trials post-exercise relative to pre-exercise only emerged in the open-skill group. In terms of the N-back task, the two exercise groups significantly increased ARs in the 1-back condition after the exercise intervention, and the beneficial AR effect on the 2-back condition only emerged in the closed-skill group. In addition, the two exercise groups exhibited significantly larger P3 amplitudes on the frontal-to-parietal cortex areas after the exercise intervention relative to the baseline when performing the two cognitive tasks. These neurocognitive results still remained unchanged even when the confounding factors (e.g., cardiorespiratory fitness, social participation, and BMI) were controlled for. The present study concluded that, although 6-month open- and closed-skill exercise interventions facilitate overall electrophysiological effects (i.e., increased ERP P3 amplitudes) on the frontal-to-parietal cortices in the elderly, the two exercise modes produced different levels of neuropsychologically beneficial effects on RTs of the task-switching paradigm (i.e., lessened RTs) and ARs of the N-back task (i.e., enhanced ARs). The distinctive neurocognitive changes induced by open- and closed-skill exercise have implications for task switching and working memory in elderly individuals, especially with such cognitive functioning impairments. PMID:28959200

Low-Energy Truly Random Number Generation with Superparamagnetic Tunnel Junctions for Unconventional Computing

NASA Astrophysics Data System (ADS)

Vodenicarevic, D.; Locatelli, N.; Mizrahi, A.; Friedman, J. S.; Vincent, A. F.; Romera, M.; Fukushima, A.; Yakushiji, K.; Kubota, H.; Yuasa, S.; Tiwari, S.; Grollier, J.; Querlioz, D.

2017-11-01

Low-energy random number generation is critical for many emerging computing schemes proposed to complement or replace von Neumann architectures. However, current random number generators are always associated with an energy cost that is prohibitive for these computing schemes. We introduce random number bit generation based on specific nanodevices: superparamagnetic tunnel junctions. We experimentally demonstrate high-quality random bit generation that represents an orders-of-magnitude improvement in energy efficiency over current solutions. We show that the random generation speed improves with nanodevice scaling, and we investigate the impact of temperature, magnetic field, and cross talk. Finally, we show how alternative computing schemes can be implemented using superparamagentic tunnel junctions as random number generators. These results open the way for fabricating efficient hardware computing devices leveraging stochasticity, and they highlight an alternative use for emerging nanodevices.

Density and energy relaxation in an open one-dimensional system

NASA Astrophysics Data System (ADS)

Jose, Prasanth P.; Bagchi, Biman

2004-05-01

A new master equation to mimic the dynamics of a collection of interacting random walkers in an open system is proposed and solved numerically. In this model, the random walkers interact through excluded volume interaction (single-file system); and the total number of walkers in the lattice can fluctuate because of exchange with a bath. In addition, the movement of the random walkers is biased by an external perturbation. Two models for the latter are considered: (1) an inverse potential (V∝1/r), where r is the distance between the center of the perturbation and the random walker and (2) an inverse of sixth power potential (V∝1/r6). The calculated density of the walkers and the total energy show interesting dynamics. When the size of the system is comparable to the range of the perturbing field, the energy relaxation is found to be highly nonexponential. In this range, the system can show stretched exponential (e-(t/τs)β) and even logarithmic time dependence of energy relaxation over a limited range of time. Introduction of density exchange in the lattice markedly weakens this nonexponentiality of the relaxation function, irrespective of the nature of perturbation.

CMOST: an open-source framework for the microsimulation of colorectal cancer screening strategies.

PubMed

Prakash, Meher K; Lang, Brian; Heinrich, Henriette; Valli, Piero V; Bauerfeind, Peter; Sonnenberg, Amnon; Beerenwinkel, Niko; Misselwitz, Benjamin

2017-06-05

Colorectal cancer (CRC) is a leading cause of cancer-related mortality. CRC incidence and mortality can be reduced by several screening strategies, including colonoscopy, but randomized CRC prevention trials face significant obstacles such as the need for large study populations with long follow-up. Therefore, CRC screening strategies will likely be designed and optimized based on computer simulations. Several computational microsimulation tools have been reported for estimating efficiency and cost-effectiveness of CRC prevention. However, none of these tools is publicly available. There is a need for an open source framework to answer practical questions including testing of new screening interventions and adapting findings to local conditions. We developed and implemented a new microsimulation model, Colon Modeling Open Source Tool (CMOST), for modeling the natural history of CRC, simulating the effects of CRC screening interventions, and calculating the resulting costs. CMOST facilitates automated parameter calibration against epidemiological adenoma prevalence and CRC incidence data. Predictions of CMOST were highly similar compared to a large endoscopic CRC prevention study as well as predictions of existing microsimulation models. We applied CMOST to calculate the optimal timing of a screening colonoscopy. CRC incidence and mortality are reduced most efficiently by a colonoscopy between the ages of 56 and 59; while discounted life years gained (LYG) is maximal at 49-50 years. With a dwell time of 13 years, the most cost-effective screening is at 59 years, at $17,211 discounted USD per LYG. While cost-efficiency varied according to dwell time it did not influence the optimal time point of screening interventions within the tested range. Predictions of CMOST are highly similar compared to a randomized CRC prevention trial as well as those of other microsimulation tools. This open source tool will enable health-economics analyses in for various countries, health-care scenarios and CRC prevention strategies. CMOST is freely available under the GNU General Public License at https://gitlab.com/misselwb/CMOST.

Laparoscopic and robot-assisted gastrectomy for gastric cancer: Current considerations

PubMed Central

Caruso, Stefano; Patriti, Alberto; Roviello, Franco; De Franco, Lorenzo; Franceschini, Franco; Coratti, Andrea; Ceccarelli, Graziano

2016-01-01

Radical gastrectomy with an adequate lymphadenectomy is the main procedure which makes it possible to cure patients with resectable gastric cancer (GC). A number of randomized controlled trials and meta-analysis provide phase III evidence that laparoscopic gastrectomy is technically safe and that it yields better short-term outcomes than conventional open gastrectomy for early-stage GC. While laparoscopic gastrectomy has become standard therapy for early-stage GC, especially in Asian countries such as Japan and South Korea, the use of minimally invasive techniques is still controversial for the treatment of more advanced tumours, principally due to existing concerns about its oncological adequacy and capacity to carry out an adequately extended lymphadenectomy. Some intrinsic drawbacks of the conventional laparoscopic technique have prevented the worldwide spread of laparoscopic gastrectomy for cancer and, despite technological advances in recent year, it remains a technically challenging procedure. The introduction of robotic surgery over the last ten years has implied a notable mutation of certain minimally invasive procedures, making it possible to overcome some limitations of the traditional laparoscopic technique. Robot-assisted gastric resection with D2 lymph node dissection has been shown to be safe and feasible in prospective and retrospective studies. However, to date there are no high quality comparative studies investigating the advantages of a robotic approach to GC over traditional laparoscopic and open gastrectomy. On the basis of the literature review here presented, robot-assisted surgery seems to fulfill oncologic criteria for D2 dissection and has a comparable oncologic outcome to traditional laparoscopic and open procedure. Robot-assisted gastrectomy was associated with the trend toward a shorter hospital stay with a comparable morbidity of conventional laparoscopic and open gastrectomy, but randomized clinical trials and longer follow-ups are needed to evaluate the possible influence of robot gastrectomy on GC patient survival. PMID:27433084

Childhood asthma and indoor woodsmoke from cooking in Guatemala.

PubMed

Schei, Morten A; Hessen, Jens O; Smith, Kirk R; Bruce, Nigel; McCracken, John; Lopez, Victorina

2004-01-01

We estimated the prevalence and severity of asthma, and the association with cooking on open wood fires, as preparation for a large-scale randomized field trial on effects of indoor air pollution and child health. This is one of the first systematic studies of asthma and indoor wood-smoke pollution and to our knowledge the first asthma study in a purely indigeneous population in Latin America. The mothers of 1058 children aged 4-6 years were interviewed, using the standardized ISAAC (International Study of Asthma and Allergies in Childhood) procedures and questionnaire. The study population is a Mam-speaking (Maya), indigenous group living at relatively high altitude (2000 m) in Western Guatemalan Highlands. We found that asthma prevalence is low among indigenous children in Guatemala, compared to other populations in Latin America. Only 3.3% of the children reported wheezing symptoms in the last 12 months, and 72% wheezing symptoms ever. The majority of the current wheezers had at least one of the criteria for severe asthma. The prevalence of all the symptoms of asthma was higher in children from households that used open fires compared to improved stoves with chimneys. In a logistic regression model, use of open fire for cooking was a significant risk factor for a number of asthma symptoms, with odds ratios varying from 2.0 to 3.5. Among the different cooking technologies (1-improved stove with chimney, 2-mixture of gas and open fire, 3-open fire) trends of higher prevalence with more pollution was found for some of the symptoms. Hence use of open fire for cooking, may be an important risk factor for asthma symptoms and severity.

Coformulated bictegravir, Emtricitabine (F), tenofovir alafenamide (TAF) after initial treatment with bictegravir or dolutegravir plus F/TAF.

PubMed

Sax, Paul E; Dejesus, Edwin; Crofoot, Gordon; Ward, Douglas; Benson, Paul; Dretler, Robin; Mills, Anthony; Brinson, Cynthia; Wei, Xuelian; Collins, Sean E; Cheng, Andrew

2018-05-22

: A phase 2, randomized, active-controlled study of initial antiretroviral therapy with bictegravir or dolutegravir in combination with emtricitabine and tenofovir alafenamide showed excellent efficacy. After 60 weeks of blinded treatment, participants switched to a single tablet regimen of bictegravir, emtricitabine and tenofovir alafenamide. Switching maintained viral suppression in all participants who chose to remain on the study through at least 12 weeks in the open-label phase, was safe and well tolerated.

Percutaneous versus traditional and paraspinal posterior open approaches for treatment of thoracolumbar fractures without neurologic deficit: a meta-analysis.

PubMed

Sun, Xiang-Yao; Zhang, Xi-Nuo; Hai, Yong

2017-05-01

This study evaluated differences in outcome variables between percutaneous, traditional, and paraspinal posterior open approaches for traumatic thoracolumbar fractures without neurologic deficit. A systematic review of PubMed, Cochrane, and Embase was performed. In this meta-analysis, we conducted online searches of PubMed, Cochrane, Embase using the search terms "thoracolumbar fractures", "lumbar fractures", ''percutaneous'', "minimally invasive", ''open", "traditional", "posterior", "conventional", "pedicle screw", "sextant", and "clinical trial". The analysis was performed on individual patient data from all the studies that met the selection criteria. Clinical outcomes were expressed as risk difference for dichotomous outcomes and mean difference for continuous outcomes with 95 % confidence interval. Heterogeneity was assessed using the χ 2 test and I 2 statistics. There were 4 randomized controlled trials and 14 observational articles included in this analysis. Percutaneous approach was associated with better ODI score, less Cobb angle correction, less Cobb angle correction loss, less postoperative VBA correction, and lower infection rate compared with open approach. Percutaneous approach was also associated with shorter operative duration, longer intraoperative fluoroscopy, less postoperative VAS, and postoperative VBH% in comparison with traditional open approach. No significant difference was found in Cobb angle correction, postoperative VBA, VBA correction loss, Postoperative VBH%, VBH correction loss, and pedicle screw misplacement between percutaneous approach and open approach. There was no significant difference in operative duration, intraoperative fluoroscopy, postoperative VAS, and postoperative VBH% between percutaneous approach and paraspianl approach. The functional and the radiological outcome of percutaneous approach would be better than open approach in the long term. Although trans-muscular spatium approach belonged to open fixation methods, it was strictly defined as less invasive approach, which provided less injury to the paraspinal muscles and better reposition effect.

Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial.

PubMed

Spieth, P M; Güldner, A; Uhlig, C; Bluth, T; Kiss, T; Conrad, C; Bischlager, K; Braune, A; Huhle, R; Insorsi, A; Tarantino, F; Ball, L; Schultz, M J; Abolmaali, N; Koch, T; Pelosi, P; Gama de Abreu, M

2018-03-01

Experimental studies showed that controlled variable ventilation (CVV) yielded better pulmonary function compared to non-variable ventilation (CNV) in injured lungs. We hypothesized that CVV improves intraoperative and postoperative respiratory function in patients undergoing open abdominal surgery. Fifty patients planned for open abdominal surgery lasting >3 h were randomly assigned to receive either CVV or CNV. Mean tidal volumes and PEEP were set at 8 ml kg -1 (predicted body weight) and 5 cm H 2 O, respectively. In CVV, tidal volumes varied randomly, following a normal distribution, on a breath-by-breath basis. The primary endpoint was the forced vital capacity (FVC) on postoperative Day 1. Secondary endpoints were oxygenation, non-aerated lung volume, distribution of ventilation, and pulmonary and extrapulmonary complications until postoperative Day 5. FVC did not differ significantly between CVV and CNV on postoperative Day 1, 61.5 (standard deviation 22.1) % vs 61.9 (23.6) %, respectively; mean [95% confidence interval (CI)] difference, -0.4 (-13.2-14.0), P=0.95. Intraoperatively, CVV did not result in improved respiratory function, haemodynamics, or redistribution of ventilation compared to CNV. Postoperatively, FVC, forced expiratory volume at the first second (FEV 1 ), and FEV 1 /FVC deteriorated, while atelectasis volume and plasma levels of interleukin-6 and interleukin-8 increased, but values did not differ between groups. The incidence of postoperative pulmonary and extrapulmonary complications was comparable in CVV and CNV. In patients undergoing open abdominal surgery, CVV did not improve intraoperative and postoperative respiratory function compared with CNV. NCT 01683578. Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

Comparison of a low-pressure and a high-pressure pulsatile lavage during débridement for orthopaedic implant infection.

PubMed

Muñoz-Mahamud, E; García, S; Bori, G; Martínez-Pastor, J C; Zumbado, J A; Riba, J; Mensa, J; Soriano, A

2011-09-01

The aim of our study was to compare the effectiveness of high-pressure pulsatile lavage and low-pressure lavage in patients with an orthopaedic implant infection treated with open débridement followed by antibiotic treatment. Patients with an orthopaedic implant infection requiring open débridement from January 2008 to August 2009 were randomized prospectively to a low-pressure or a high-pressure pulsatile lavage arm. Relevant information about demographics, co-morbidity, type of implant, microbiology data, surgical treatment, and outcome were recorded. Comparison of proportions was made using χ(2) test or Fisher exact test when necessary. The Kaplan-Meier survival method was used to estimate the cumulative probability of treatment failure from open débridement to the last visit. Seventy-nine patients were included. There were no differences between the main characteristics between both groups (p > 0.05). Mean (SD) age of the whole cohort was 70.2 (11.9) years. There were 46 infections on knee prosthesis, 17 on hip prosthesis, 7 on hip hemiarthroplasties and 9 on osteosynthesis devices. There were 69 acute post-surgical infections, 8 acute haematogenous infections and 2 chronic infections. The most common microorganisms isolated were coagulase-negative Staphylococci in 34 cases, Staphylococcus aureus in 26 and Escherichia coli in 19 cases. There were 30 polymicrobial infections. A total of 42 and 37 patients were randomized to a high-pressure pulsatile or a low-pressure lavage, respectively. There was no difference in the success rate between both arms (80.9 vs. 86.5%, p = 0.56). The use of a high-pressure pulsatile lavage during open débridement of implant infections had a similar success rate as a low-pressure lavage.

Endoscopic and laparoscopic treatment of gastroesophageal reflux.

PubMed

Watson, David I; Immanuel, Arul

2010-04-01

Gastroesophageal reflux is extremely common in Western countries. For selected patients, there is an established role for the surgical treatment of reflux, and possibly an emerging role for endoscopic antireflux procedures. Randomized trials have compared medical versus surgical management, laparoscopic versus open surgery and partial versus total fundoplications. However, the evidence base for endoscopic procedures is limited to some small sham-controlled studies, and cohort studies with short-term follow-up. Laparoscopic fundoplication has been shown to be an effective antireflux operation. It facilitates quicker convalescence and is associated with fewer complications, but has a similar longer term outcome compared with open antireflux surgery. In most randomized trials, antireflux surgery achieves at least as good control of reflux as medical therapy, and these studies support a wider application of surgery for the treatment of moderate-to-severe reflux. Laparoscopic partial fundoplication is an effective surgical procedure with fewer side effects, and it may achieve high rates of patient satisfaction at late follow-up. Many of the early endoscopic antireflux procedures have failed to achieve effective reflux control, and they have been withdrawn from the market. Newer procedures have the potential to fashion a surgical fundoplication. However, at present there is insufficient evidence to establish the safety and efficacy of endoscopic procedures for the treatment of gastroesophageal reflux, and no endoscopic procedure has achieved equivalent reflux control to that achieved by surgical fundoplication.

Improved Lipid Profile Associated with Daily Consumption of Tri-Sura-Phon in Healthy Overweight Volunteers: An Open-Label, Randomized Controlled Trial

PubMed Central

Kuamsub, Sirigoon; Singthong, Pariyaphat; Chanthasri, Wipawee; Chobngam, Nicharee; Sangkaew, Warissara; Hemdecho, Sasithorn; Kaewmanee, Thammarat

2017-01-01

Tri-Sura-Phon (TSP), a traditional Thai polyherbal formula renowned for its rejuvenating properties, is commonly used as a blood tonic. It comprises Cinnamomum bejolghota, Cinnamomum parthenoxylon, and Aquilaria crassna. The aim of this study is to evaluate the beneficial properties of TSP tea consumption on blood glucose regulation and serum lipid profiles of healthy overweight volunteers. This open-label, randomized controlled trial was conducted in 70 healthy overweight adults. Two groups of 35 subjects took a TSP infusion or a placebo (cornstarch) twice daily for 8 weeks. The blood glucose regulation, serum lipid profiles, BMI, and liver function tests of the subjects were determined at the baseline, 4th week, and endpoint (8th week). Significant decreases in the average fasting levels of total cholesterol (p = 0.013), triglyceride (p = 0.001), and low-density lipoprotein (LDL, p = 0.017) were observed in the TSP group at the 8th week compared to those at the baseline. The average HDL level in the TSP group at the beginning of the study was 65.2 mg/dL, and it increased significantly (p = 0.005) to 72.4 mg/dL after 8 weeks of TSP intake. This study showed that the intake of TSP tea as an antioxidant-rich beverage might be safe and improve lipid profiles in overweight adults. PMID:28484502

Efficacy of losartan and carvedilol on central hemodynamics in hypertensives: a prospective, randomized, open, blinded end point, multicenter study.

PubMed

Kim, Eung Ju; Song, Woo-Hyuk; Lee, Jae Ung; Shin, Mi-Seung; Lee, Sahng; Kim, Byeong-Ok; Hong, Kyeong-Sun; Han, Seong Woo; Park, Chang Gyu; Seo, Hong Seog

2014-01-01

Renin-angiotensin system (RAS) blockers have shown clinical outcomes superior to those of the beta (β)-blocker atenolol, despite similar reductions in the peripheral blood pressure (BP), perhaps because of different impacts on central hemodynamics. However, few comparative studies of RAS blockers and newer vasodilating β-blockers have been performed. We compared the central hemodynamic effects of losartan and carvedilol in a prospective, randomized, open, blinded end point study. Of the 201 hypertensive patients enrolled, 182 (49.6±9.9 years, losartan group=88 and carvedilol group=94) were analyzed. Carotid-femoral pulse wave velocity (cfPWV), aortic augmentation index (AIx), AIx corrected for a heart rate (HR) of 75 beats per minute (AIx@HR75) and central BP were measured noninvasively at baseline and after a 24-week treatment regimen with losartan or carvedilol. After 24 weeks, there were no between-group differences in the brachial BP, cfPWV, AIx@HR75 or central BP changes, except for a more favorable AIx effect with losartan. The changes in all measured metabolic and inflammatory parameters were also not significantly different between the two groups, except for uric acid. Losartan and carvedilol showed generally comparable effects on central hemodynamic indices, metabolic profile, inflammatory parameters and peripheral arterial pressure with a 24-week treatment.

Pulmonary atelectasis during low stretch ventilation: "open lung" versus "lung rest" strategy.

PubMed

Fanelli, Vito; Mascia, Luciana; Puntorieri, Valeria; Assenzio, Barbara; Elia, Vincenzo; Fornaro, Giancarlo; Martin, Erica L; Bosco, Martino; Delsedime, Luisa; Fiore, Tommaso; Grasso, Salvatore; Ranieri, V Marco

2009-03-01

Limiting tidal volume (VT) may minimize ventilator-induced lung injury (VILI). However, atelectasis induced by low VT ventilation may cause ultrastructural evidence of cell disruption. Apoptosis seems to be involved as protective mechanisms from VILI through the involvement of mitogen-activated protein kinases (MAPKs). We examined the hypothesis that atelectasis may influence the response to protective ventilation through MAPKs. Prospective randomized study. University animal laboratory. Adult male 129/Sv mice. Isolated, nonperfused lungs were randomized to VILI: VT of 20 mL/kg and positive end-expiratory pressure (PEEP) zero; low stretch/lung rest: VT of 6 mL/kg and 8-10 cm H2O of PEEP; low stretch/open lung: VT of 6 mL/kg, two recruitment maneuvers and 14-16 cm H2O of PEEP. Ventilator settings were adjusted using the stress index. Both low stretch strategies equally blunted the VILI-induced derangement of respiratory mechanics (static volume-pressure curve), lung histology (hematoxylin and eosin), and inflammatory mediators (interleukin-6, macrophage inflammatory protein-2 [enzyme-linked immunosorbent assay], and inhibitor of nuclear factor-kB[Western blot]). VILI caused nuclear swelling and membrane disruption of pulmonary cells (electron microscopy). Few pulmonary cells with chromatin condensation and fragmentation were seen during both low stretch strategies. However, although cell thickness during low stretch/open lung was uniform, low stretch/lung rest demonstrated thickening of epithelial cells and plasma membrane bleb formation. Compared with the low stretch/open lung, low stretch/lung rest caused a significant decrease in apoptotic cells (terminal deoxynucleotidyl transferase mediated deoxyuridine-triphosphatase nick end-labeling) and tissue expression of caspase-3 (Western blot). Both low stretch strategies attenuated the activation of MAPKs. Such reduction was larger during low stretch/open lung than during low stretch/lung rest (p < 0.001). Low stretch strategies provide similar attenuation of VILI. However, low stretch/lung rest strategy is associated to less apoptosis and more ultrastructural evidence of cell damage possibly through MAPKs-mediated pathway.

Does the sequence of data collection influence participants' responses to closed and open-ended questions? A methodological study.

PubMed

Covell, Christine L; Sidani, Souraya; Ritchie, Judith A

2012-06-01

The sequence used for collecting quantitative and qualitative data in concurrent mixed-methods research may influence participants' responses. Empirical evidence is needed to determine if the order of data collection in concurrent mixed methods research biases participants' responses to closed and open-ended questions. To examine the influence of the quantitative-qualitative sequence on responses to closed and open-ended questions when assessing the same variables or aspects of a phenomenon simultaneously within the same study phase. A descriptive cross-sectional, concurrent mixed-methods design was used to collect quantitative (survey) and qualitative (interview) data. The setting was a large multi-site health care centre in Canada. A convenience sample of 50 registered nurses was selected and participated in the study. Participants were randomly assigned to one of two sequences for data collection, quantitative-qualitative or qualitative-quantitative. Independent t-tests were performed to compare the two groups' responses to the survey items. Directed content analysis was used to compare the participants' responses to the interview questions. The sequence of data collection did not greatly affect the participants' responses to the closed-ended questions (survey items) or the open-ended questions (interview questions). The sequencing of data collection, when using both survey and semi-structured interviews, may not bias participants' responses to closed or open-ended questions. Additional research is required to confirm these findings. Copyright © 2011 Elsevier Ltd. All rights reserved.

Prevention of hypothermia in patients undergoing orthotopic liver transplantation using the humigard® open surgery humidification system: a prospective randomized pilot and feasibility clinical trial.

PubMed

Weinberg, Laurence; Huang, Andrew; Alban, Daniel; Jones, Robert; Story, David; McNicol, Larry; Pearce, Brett

2017-01-23

Perioperative thermal disturbances during orthotopic liver transplantation (OLT) are common. We hypothesized that in patients undergoing OLT the use of a humidified high flow CO 2 warming system maintains higher intraoperative temperatures when compared to standardized multimodal strategies to maintain thermoregulatory homeostasis. We performed a randomized pilot study in adult patients undergoing primary OLT. Participants were randomized to receive either open wound humidification with a high flow CO 2 warming system in addition to standard care (Humidification group) or to standard care alone (Control group). The primary end point was nasopharyngeal core temperature measured 5 min immediately prior to reperfusion of the donor liver (Stage 3 - 5 min). Secondary endpoints included intraoperative PaCO 2 , minute ventilation and the use of vasoconstrictors. Eleven patients were randomized to each group. Both groups were similar for age, body mass index, MELD, SOFA and APACHE II scores, baseline temperature, and duration of surgery. Immediately prior to reperfusion (Stage 3 - 5 min) the mean (SD) core temperature was higher in the Humidification Group compared to the Control Group: 36.0 °C (0.13) vs. 35.4 °C (0.22), p = 0.028. Repeated measured ANOVA showed that core temperatures over time during the stages of the transplant were higher in the Humidification Group compared to the Control Group (p < 0.0001). There were no significant differences in the ETCO 2 , PaCO 2 , minute ventilation, or inotropic support. The humidified high flow CO 2 warming system was superior to standardized multimodal strategies in maintaining normothermia in patients undergoing OLT. Use of the device was feasible and did not interfere with any aspects of surgery. A larger study is needed to investigate if the improved thermoregulation observed is associated with improved patient outcomes. ACTRN12616001631493 . Retrospectively registered 25 November 2016.

The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial

PubMed Central

Van Buren, Peter N.; Lewis, Julia B.; Dwyer, Jamie P.; Greene, Tom; Middleton, John; Sika, Mohammed; Umanath, Kausik; Abraham, Josephine D.; Arfeen, Shahabul S.; Bowline, Isai G.; Chernin, Gil; Fadem, Stephen Z.; Goral, Simin; Koury, Mark; Sinsakul, Marvin V.; Weiner, Daniel E.

2016-01-01

Background Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients. Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels. Study Design 52-week, open-label, phase 3, randomized, controlled trial for safety-profile assessment. Setting & Participants Maintenance dialysis patients with serum phosphorus levels ≥6.0 mg/dL after washout of prior phosphate binders. Intervention 2:1 randomization to ferric citrate or active control (sevelamer carbonate and/or calcium acetate). Outcomes Changes in mineral bone disease, protein-energy wasting/inflammation, and occurrence of adverse events after 1 year. Measurements Serum calcium, intact parathyroid hormone, phosphorus, aluminum, white blood cell count, percentage of lymphocytes, serum urea nitrogen, and bicarbonate. Results There were 292 participants randomly assigned to ferric citrate, and 149, to active control. Groups were well matched. For mean changes from baseline, phosphorus levels decreased similarly in the ferric citrate and active control groups (−2.04 ± 1.99 [SD] vs −2.18 ± 2.25 mg/dL, respectively; P = 0.9); serum calcium levels increased similarly in the ferric citrate and active control groups (0.22 ± 0.90 vs 0.31 ± 0.95 mg/dL; P = 0.2). Hypercalcemia occurred in 4 participants receiving calcium acetate. Parathyroid hormone levels decreased similarly in the ferric citrate and active control groups (−167.1 ± 399.8 vs −152.7 ± 392.1 pg/mL; P = 0.8). Serum albumin, bicarbonate, serum urea nitrogen, white blood cell count and percentage of lymphocytes, and aluminum values were similar between ferric citrate and active control. Total and low-density lipoprotein cholesterol levels were lower in participants receiving sevelamer than those receiving ferric citrate and calcium acetate. Fewer participants randomly assigned to ferric citrate had serious adverse events compared with active control. Limitations Open-label study, few peritoneal dialysis patients. Conclusions Ferric citrate was associated with similar phosphorus control compared to active control, with similar effects on markers of bone and mineral metabolism in dialysis patients. There was no evidence of protein-energy wasting/inflammation or aluminum toxicity, and fewer participants randomly assigned to ferric citrate had serious adverse events. Ferric citrate is an effective phosphate binder with a safety profile comparable to sevelamer and calcium acetate. PMID:25958079

DOE Office of Scientific and Technical Information (OSTI.GOV)

Alparslan, Burcu, E-mail: burcu.alparslan@gmail.com; Nas, Omer Fatih, E-mail: omerfatihnas@gmail.com; Eritmen, Ulku Turpcu, E-mail: drulkutur@hotmail.com.tr

PurposeThe aim of this study was to investigate the effect of stent cell geometry on midterm results of carotid artery stenting (CAS).Materials and MethodOne hundred fifty-five patients underwent CAS between February 2010 and December 2012. Ninety-one open- and 84 closed-cell stents were used in this non-randomized, retrospective study. Periprocedural complications were defined as the ones happened during the procedure or within 30 days afterwards. Starting from the 6th month after the procedure, in-stent restenosis was detected with multidetector computed tomography angiography and classified into four groups from focal restenosis to occlusion.ResultsEleven complications were encountered in the periprocedural period (four on themore » open- and seven on the closed-cell group). Total complication rate was 6.3 % (11/175). No significant difference was detected in terms of periprocedural complications between two groups (p = 0.643). There was statistically significant difference between stent design groups in regard to radiological findings (p = 0.002). Sixteen of open-cell stents and three of closed-cell stents had focal restenosis. One closed-cell stent had diffuse proliferative restenosis and one open-cell stent had total occlusion.ConclusionIn-stent restenosis was more common in open-cell stent group, which have larger free cell area than closed-cell stents. Although our radiologic findings promote us to use closed-cell design if ‘possible’, no difference was detected in terms of clinical outcomes.« less

Endoscopic ultrasound cytologic brushing vs endoscopic ultrasound: fine needle aspiration for cytological diagnosis of cystic pancreatic lesions. A multicenter, randomized open-label trial.

PubMed

Lariño-Noia, José; de la Iglesia, Daniel; Iglesias-García, Julio; Macías, Manuel; López Martín, Aurelio; Legaz, María Luisa; Vila, Juan; Reyes, Antonio; Abdulkader, Ihab; Domínguez-Muñoz, J Enrique

2018-04-24

the incidence of cystic pancreatic lesions (CPL) in the asymptomatic population is increasing. Achieving a preoperative diagnosis of CPL still remains a challenge. to evaluate the diagnostic accuracy of the cytological diagnosis of CPL from samples obtained by cytology brush versus standard endoscopic ultrasound fine needle aspiration (EUS-FNA). a multicenter, randomized, open-label trial was performed of EUS-cytology brush (EUS-EB) versus EUS-FNA for the cytological diagnosis of CPL. Patients that underwent EUS-FNA with a CPL > 15 mm were included and randomized into two groups: group I, EUS-EB; group II, EUS-FNA. The final diagnosis was based on the histological evaluation of surgical specimens and clinical parameters, imaging and a five year follow-up in non-operated patients. The main outcome was the diagnostic accuracy of both methods. Secondary outcomes were the diagnostic adequacy of specimens and the rate of adverse events. Data were compared using the Chi-squared test. An intention to treat (ITT) and per-protocol (PP) analysis were performed. sixty-five patients were included in the study, 31 in group I and 34 in group II. Three patients initially randomized to group I were changed to group II as it was impossible to obtain a sample using the brush. The mean size of the CPL was 28.2 mm (range 16-60 mm). The diagnostic accuracy of EUS-EB was not superior to EUS-FNA, neither in the ITT nor the PP analysis (44.8% vs 41.1%, p = 0.77 and 38.4% vs 45.9%, p = 0.55). EUS-EB does not improve the diagnostic accuracy of CPL in comparison with EUS-FNA.

Open-label, randomized, non-inferiority clinical trial of artesunate-amodiaquine versus artemether-lumefantrine fixed-dose combinations in children and adults with uncomplicated falciparum malaria in Côte d'Ivoire.

PubMed

Toure, Offianan A; Assi, Serge B; N'Guessan, Tiacoh L; Adji, Gbessi E; Ako, Aristide B; Brou, Marie J; Ehouman, Marie F; Gnamien, Laeticia A; Coulibaly, M'Lanhoro A A; Coulibaly, Baba; Beourou, Sylvain; Bassinka, Issiaka; Soumahoro, Adama; Kadjo, Florence; Tano, Mea A

2014-11-19

Emergence of artemisinin resistance has raised concerns that the most potent anti-malarial drug may be under threat. Artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AL) are, respectively, the first- and second-line treatments for uncomplicated falciparum malaria in Côte d'Ivoire. Constant monitoring by National Malaria Control Programme (NMCP) of drug efficacy is an important tool in establishing rational anti-malarial drug policies in Côte d'Ivoire. In an open label, randomized controlled clinical trial, children and adults were randomized to receive AS-AQ or AL. Both drug regimens were given for three days, and follow-up was for 42 days. The primary endpoint was the 42-day cure rate and was defined as proportion of patients with PCR-corrected cure rate after 42 days of follow-up. A total of 383 patients who were attending the Anonkoua-koute (Abidjan), Petit Paris (Korhogo) and Libreville (Man) hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive AS-AQ (188) and AL (195). The intention-to-treat analysis showed effectiveness rates of 94.7% and 96.4% for AS-AQ and AL, respectively on day 42. After adjustment for PCR, these rates were 96.8% and 99%, respectively. At day 42, in per-protocol analysis, Adequate clinical and parasitological response (ACPR) PCR uncorrected was 97.8% and 97.4% for AS-AQ and AL, respectively. The PCR adjusted ACPR was 100% for each combination and both regimens were well tolerated. This study has shown the high efficacy of AS-AQ in patients of all ages with acute uncomplicated falciparum malaria and AS-AQ was non-inferior to AL. Continuous efficacy monitoring is recommended.

Open-label extension studies: do they provide meaningful information on the safety of new drugs?

PubMed

Day, Richard O; Williams, Kenneth M

2007-01-01

The number of open-label extension studies being performed has increased enormously in recent years. Often it is difficult to differentiate between these extension studies and the double-blind, controlled studies that preceded them. If undertaken primarily to gather more patient-years of exposure to the new drug in order to understand and gain confidence in its safety profile, open-label extension studies can play a useful and legitimate role in drug development and therapeutics. However, this can only occur if the open-label extension study is designed, executed, analysed and reported competently. Most of the value accrued in open-label extension studies is gained from a refinement in the perception of the expected incidence of adverse effects that have most likely already been identified as part of the preclinical and clinical trial programme. We still have to rely heavily on post-marketing safety surveillance systems to alert us to type B (unpredictable) adverse reactions because open-label extension studies are unlikely to provide useful information about these types of often serious and relatively rare adverse reactions. Random allocation into test and control groups is needed to produce precise incidence data on pharmacologically expected, or type A, adverse effects. Some increased confidence about incidence rates might result from the open-label extension study; however, as these studies are essentially uncontrolled and biased, the data are not of great value. Other benefits have been proposed to be gained from open-label extension studies. These include ongoing access to an effective but otherwise unobtainable medicine by the volunteers who participated in the phase III pivotal trials. However, there are unappreciated ethical issues about the appropriateness of enrolling patients whose response to previous treatment is uncertain, largely because treatment allocation in the preceding randomised, double-blind, controlled trial has not been revealed at the time of entry into the open-label extension study. Negative aspects of open-label extension studies revolve around their use as a marketing tool, as they build a market for the drug and generate pressure for subsidised access to the drug from consumers and their physicians. Consumers, institutions where these studies are conducted and research ethics committees need to be convinced of the motives, as well as the quality, of the open-label extension study and its execution before supporting such studies. Open-label extension studies do have a legitimate but limited place in the clinical development of new medicines. The negative perceptions about these studies have arisen because of perversion of acceptable rationales for this type of study and a failure to recognise (or disclose) the limitations resulting from the inherent weaknesses in their design. Increased human exposure to a new medicine under reasonably controlled circumstances to increase confidence in the safety of the medicine is an acceptable rationale for an open-label extension study, and a useful activity to increase the knowledge of the safety profile of a new medicine. However, this goal is increasingly being achieved by means other than open-label extension studies.

Cascaded Raman lasing in a PM phosphosilicate fiber with random distributed feedback

NASA Astrophysics Data System (ADS)

Lobach, Ivan A.; Kablukov, Sergey I.; Babin, Sergey A.

2018-02-01

We report on the first demonstration of a linearly polarized cascaded Raman fiber laser based on a simple half-open cavity with a broadband composite reflector and random distributed feedback in a polarization maintaining phosphosilicate fiber operating beyond zero dispersion wavelength ( 1400 nm). With increasing pump power from a Yb-doped fiber laser at 1080 nm, the random laser generates subsequently 8 W at 1262 nm and 9 W at 1515 nm with polarization extinction ratio of 27 dB. The generation linewidths amount to about 1 nm and 3 nm, respectively, being almost independent of power, in correspondence with the theory of a cascaded random lasing.

Spectral density of mixtures of random density matrices for qubits

NASA Astrophysics Data System (ADS)

Zhang, Lin; Wang, Jiamei; Chen, Zhihua

2018-06-01

We derive the spectral density of the equiprobable mixture of two random density matrices of a two-level quantum system. We also work out the spectral density of mixture under the so-called quantum addition rule. We use the spectral densities to calculate the average entropy of mixtures of random density matrices, and show that the average entropy of the arithmetic-mean-state of n qubit density matrices randomly chosen from the Hilbert-Schmidt ensemble is never decreasing with the number n. We also get the exact value of the average squared fidelity. Some conjectures and open problems related to von Neumann entropy are also proposed.

Doppler spectra of airborne ultrasound forward scattered by the rough surface of open channel turbulent water flows.

PubMed

Dolcetti, Giulio; Krynkin, Anton

2017-11-01

Experimental data are presented on the Doppler spectra of airborne ultrasound forward scattered by the rough dynamic surface of an open channel turbulent flow. The data are numerically interpreted based on a Kirchhoff approximation for a stationary random water surface roughness. The results show a clear link between the Doppler spectra and the characteristic spatial and temporal scales of the water surface. The decay of the Doppler spectra is proportional to the velocity of the flow near the surface. At higher Doppler frequencies the measurements show a less steep decrease of the Doppler spectra with the frequency compared to the numerical simulations. A semi-empirical equation for the spectrum of the surface elevation in open channel turbulent flows over a rough bed is provided. The results of this study suggest that the dynamic surface of open channel turbulent flows can be characterized remotely based on the Doppler spectra of forward scattered airborne ultrasound. The method does not require any equipment to be submerged in the flow and works remotely with a very high signal to noise ratio.

Coherent random lasing controlled by Brownian motion of the active scatterer

NASA Astrophysics Data System (ADS)

Liang, Shuofeng; Yin, Leicheng; Zhang, ZhenZhen; Xia, Jiangying; Xie, Kang; Zou, Gang; Hu, Zhijia; Zhang, Qijin

2018-05-01

The stability of the scattering loop is fundamental for coherent random lasing in a dynamic scattering system. In this work, fluorescence of DPP (N, N-di [3-(isobutyl polyhedral oligomeric silsesquioxanes) propyl] perylene diimide) is scattered to produce RL and we realize the transition from incoherent RL to coherent RL by controlling the Brownian motion of the scatterers (dimer aggregates of DPP) and the stability of scattering loop. To produce coherent random lasers, the loop needs to maintain a stable state within the loop-stable time, which can be determined through controlled Brownian motion of scatterers in the scattering system. The result shows that the loop-stable time is within 5.83 × 10‑5 s to 1.61 × 10‑4 s based on the transition from coherent to incoherent random lasing. The time range could be tuned by finely controlling the viscosity of the solution. This work not only develops a method to predict the loop-stable time, but also develops the study between Brownian motion and random lasers, which opens the road to a variety of novel interdisciplinary investigations involving modern statistical mechanics and disordered photonics.

Random density matrices versus random evolution of open system

NASA Astrophysics Data System (ADS)

Pineda, Carlos; Seligman, Thomas H.

2015-10-01

We present and compare two families of ensembles of random density matrices. The first, static ensemble, is obtained foliating an unbiased ensemble of density matrices. As criterion we use fixed purity as the simplest example of a useful convex function. The second, dynamic ensemble, is inspired in random matrix models for decoherence where one evolves a separable pure state with a random Hamiltonian until a given value of purity in the central system is achieved. Several families of Hamiltonians, adequate for different physical situations, are studied. We focus on a two qubit central system, and obtain exact expressions for the static case. The ensemble displays a peak around Werner-like states, modulated by nodes on the degeneracies of the density matrices. For moderate and strong interactions good agreement between the static and the dynamic ensembles is found. Even in a model where one qubit does not interact with the environment excellent agreement is found, but only if there is maximal entanglement with the interacting one. The discussion is started recalling similar considerations for scattering theory. At the end, we comment on the reach of the results for other convex functions of the density matrix, and exemplify the situation with the von Neumann entropy.

Effects of combination oral care on oral health, dry mouth and salivary pH of intubated patients: A randomized controlled trial.

PubMed

Jang, Chun Sun; Shin, Yong Soon

2016-10-01

Intubated patients are at risk of oral health problems. Although a variety of oral care regimens for intubated patients have been studied, there is a lack of research on the effects of combination oral care that includes tooth brushing, chlorhexidine and cold water. This open-labelled, randomized, controlled trial aimed to evaluate the effects of combination oral care on oral health status. Participants aged 20 years and older were recruited on the first day after intubation through convenience sampling in a medical intensive care unit. Random assignment was performed using an internet randomization service. The primary outcome was oral health status. Data were collected during May and June 2013. Participants were randomized to one of two groups (23 intervention and 21 control). The final analysis included 18 patients with combination oral care and 17 in the control group. The intervention group had better oral health (effect size = 1.56), less dry mouth and higher salivary pH than the control group. Any additional burden of providing combination oral care to patients who are mechanically ventilated is worthwhile in terms of clinical outcomes. © 2016 John Wiley & Sons Australia, Ltd.

The Japan Statin Treatment Against Recurrent Stroke (J-STARS): A Multicenter, Randomized, Open-label, Parallel-group Study.

PubMed

Hosomi, Naohisa; Nagai, Yoji; Kohriyama, Tatsuo; Ohtsuki, Toshiho; Aoki, Shiro; Nezu, Tomohisa; Maruyama, Hirofumi; Sunami, Norio; Yokota, Chiaki; Kitagawa, Kazuo; Terayama, Yasuo; Takagi, Makoto; Ibayashi, Setsuro; Nakamura, Masakazu; Origasa, Hideki; Fukushima, Masanori; Mori, Etsuro; Minematsu, Kazuo; Uchiyama, Shinichiro; Shinohara, Yukito; Yamaguchi, Takenori; Matsumoto, Masayasu

2015-09-01

Although statin therapy is beneficial for the prevention of initial stroke, the benefit for recurrent stroke and its subtypes remains to be determined in Asian, in whom stroke profiles are different from Caucasian. This study examined whether treatment with low-dose pravastatin prevents stroke recurrence in ischemic stroke patients. This is a multicenter, randomized, open-label, blinded-endpoint, parallel-group study of patients who experienced non-cardioembolic ischemic stroke. All patients had a total cholesterol level between 4.65 and 6.21 mmol/L at enrollment, without the use of statins. The pravastatin group patients received 10 mg of pravastatin/day; the control group patients received no statins. The primary endpoint was the occurrence of stroke and transient ischemic attack (TIA), with the onset of each stroke subtype set to be one of the secondary endpoints. Although 3000 patients were targeted, 1578 patients (491 female, age 66.2 years) were recruited and randomly assigned to pravastatin group or control group. During the follow-up of 4.9 ± 1.4 years, although total stroke and TIA similarly occurred in both groups (2.56 vs. 2.65%/year), onset of atherothrombotic infarction was less frequent in pravastatin group (0.21 vs. 0.64%/year, p = 0.0047, adjusted hazard ratio 0.33 [95%CI 0.15 to 0.74]). No significant intergroup difference was found for the onset of other stroke subtypes, and for the occurrence of adverse events. Although whether low-dose pravastatin prevents recurrence of total stroke or TIA still needs to be examined in Asian, this study has generated a hypothesis that it may reduce occurrence of stroke due to larger artery atherosclerosis. This study was initially supported by a grant from the Ministry of Health, Labour and Welfare, Japan. After the governmental support expired, it was conducted in collaboration between Hiroshima University and the Foundation for Biomedical Research and Innovation.

High-dose levofloxacin in community-acquired pneumonia: a randomized, open-label study.

PubMed

Lee, Jin Hwa; Kim, Seo Woo; Kim, Ji Hye; Ryu, Yon Ju; Chang, Jung Hyun

2012-09-01

The conventional treatment for community-acquired pneumonia (CAP) involves combination therapy consisting of a β-lactam penicillin or a cephalosporin with a macrolide. Alternatively, high-dose levofloxacin treatment has been used as single-agent therapy for treating CAP, covering atypical pathogens. This study compared the clinical efficacy and safety of high-dose levofloxacin with combined ceftriaxone and azithromycin for the treatment of CAP. This phase IV, prospective, randomized, open-label trial enrolled patients admitted to a tertiary referral hospital for CAP treatment from 2010 to 2011. Hospital admission was decided based on clinical judgement and the pneumonia severity index. Forty subjects were enrolled and assigned to two treatment arms using a random numbers table. The 20 subjects in the experimental group were given levofloxacin 750 mg intravenously once daily, followed by the same dose of oral levofloxacin at discharge when clinically improved and the 20 subjects in the control group were given ceftriaxone 2.0 g intravenously once daily plus oral azithromycin 500 mg for 3 consecutive days, followed by oral cefpodoxime 200 mg per day at discharge after clinical improvement. The primary outcome was the clinical success rate. Secondary outcomes were the microbiological success rate and adverse events during the study. Of the 40 subjects enrolled, 36 completed the study: 17 in the experimental group and 19 in the control group. The groups did not differ in terms of demographic factors or clinical findings at baseline. The clinical success rate (cured + improved) was 94% in the experimental (levofloxacin) group and 84% in the control group (p > 0.05). The microbiological success rate and overall adverse events were also similar in both groups. Single-agent, high-dose levofloxacin treatment exhibited excellent clinical and microbiological efficacy with a safety profile comparable to that of ceftriaxone plus azithromycin therapy. Large-scale clinical trials are required to verify these results. WHO International Clinical Trials Registry: KCT0000374; Daiichi-Sankyo Korea study code: T11-13-V1.

Double-blind, Randomized, 8-week Placebo-controlled followed by a 16-week open label extension study, with the LPA1 receptor antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis.

PubMed

Allanore, Yannick; Distler, Oliver; Jagerschmidt, Alexandre; Illiano, Stephane; Ledein, Laetitia; Boitier, Eric; Agueusop, Inoncent; Denton, Christopher P; Khanna, Dinesh

2018-05-06

Preclinical studies suggest a role for lysophosphatidic acid (LPA) in the pathogenesis of systemic sclerosis (SSc). SAR100842, a potent selective oral antagonist of LPA1 receptor, was assessed for safety, biomarkers and clinical efficacy in patients with diffuse cutaneous SSc (dcSSc). An 8-week double-blind, randomized, placebo-controlled study followed by a 16-week open label extension with SAR100842 was performed in patients with early dcSSc and a baseline Rodnan skin score (mRSS) of at least 15. The primary endpoint was safety during the double-blind phase of the trial. Exploratory endpoints included the identification of a LPA-induced gene signature in patients 'skin. 17 of 32 subjects were randomized to placebo and 15 to SAR100842; 30 patients participated in the extension study. The most frequent adverse events reported for SAR100842 during the blinded phase were headache, diarrhea, nausea and fall and the safety profile was acceptable during the extension part. At Week 8, mean reduction in mRSS was numerically greater in the SAR100842 compared to placebo (mean change [SD]: -3.57 [4.18] versus -2.76 [4.85]; difference [95% CI]: -1.2 [-4.37 to 2.02], p=0.46). A greater reduction of LPA related genes was observed in skin of SAR100842 group at Week 8, indicating LPA 1 target engagement. SAR100842, a selective orally available LPA 1 receptor antagonist, was well tolerated in patients with dcSSc. MRSS improved during the study although not reaching significance, and additional gene signature analysis suggested target engagement. These results need to be confirmed in a larger controlled trial. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Effect of heart failure reversal treatment as add-on therapy in patients with chronic heart failure: A randomized, open-label study.

PubMed

Sane, Rohit; Aklujkar, Abhijeet; Patil, Atul; Mandole, Rahul

The present study was designed to evaluate effect of heart failure reversal therapy (HFRT) using herbal procedure (panchakarma) and allied therapies, as add-on to standard CHF treatment (SCT) in chronic heart failure (CHF) patients. This open-label, randomized study conducted in CHF patients (aged: 25-65 years, ejection fraction: 30-65%), had 3-phases: 1-week screening, 6-week treatment (randomized [1:1] to HFRT+SCT or SCT-alone) and follow-up (12-week). Twice weekly HFRT (60-75min) consisting of snehana (external oleation), swedana (passive heat therapy), hrudaydhara (concoction dripping treatment) and basti (enema) was administered. Primary endpoints included evaluation of change in metabolic equivalents of task (MET) and peak oxygen uptake (VO 2peak ) from baseline, at end of 6-week treatment and follow-up at week-18 (non-parametric rank ANCOVA analysis). Safety and quality of life (QoL) was assessed. Seventy CHF patients (n=35, each treatment-arm; mean [SD] age: 53.0 [8.6], 80% men) were enrolled in the study. All patients completed treatment phase. Add-on HFRT caused a significant increase in METs (least square mean difference [LSMD], 6-week: 1.536, p=0.0002; 18-week: -1.254, p=0.0089) and VO 2peak (LSMD, 6-week: -5.52, p=0.0002; 18-week: -4.517, p=0.0089) as compared with SCT-alone. Results were suggestive of improved functional capacity in patients with HFRT (QoL; Mean [SD] HFRT+SCT vs. SCT-alone; 6-week: -0.44 [0.34] vs. -0.06 [0.25], p<0.0001 and 18-week: -0.53 [0.35] vs. -0.29 [0.26], p=0.0013). Seven treatment-emergent adverse events (mild severity) were reported in HFRT-arm. Findings of this study highlight therapeutic efficacy of add-on HFRT vs. SCT-alone in CHF patients. The non-invasive HFRT showed no safety concerns. Copyright © 2016. Published by Elsevier B.V.

The immediate effects of atlanto-occipital joint manipulation and suboccipital muscle inhibition technique on active mouth opening and pressure pain sensitivity over latent myofascial trigger points in the masticatory muscles.

PubMed

Oliveira-Campelo, Natalia M; Rubens-Rebelatto, José; Martí N-Vallejo, Francisco J; Alburquerque-Sendí N, Francisco; Fernández-de-Las-Peñas, César

2010-05-01

A randomized controlled trial. To investigate the immediate effects on pressure pain thresholds over latent trigger points (TrPs) in the masseter and temporalis muscles and active mouth opening following atlanto-occipital joint thrust manipulation or a soft tissue manual intervention targeted to the suboccipital muscles. Previous studies have described hypoalgesic effects of neck manipulative interventions over TrPs in the cervical musculature. There is a lack of studies analyzing these mechanisms over TrPs of muscles innervated by the trigeminal nerve. One hundred twenty-two volunteers, 31 men and 91 women, between the ages of 18 and 30 years, with latent TrPs in the masseter muscle, were randomly divided into 3 groups: a manipulative group who received an atlanto-occipital joint thrust, a soft tissue group who received an inhibition technique over the suboccipital muscles, and a control group who did not receive an intervention. Pressure pain thresholds over latent TrPs in the masseter and temporalis muscles, and active mouth opening were assessed pretreatment and 2 minutes posttreatment by a blinded assessor. Mixed-model analyses of variance (ANOVA) were used to examine the effects of interventions on each outcome, with group as the between-subjects variable and time as the within-subjects variable. The primary analysis was the group-by-time interaction. The 2-by-3 mixed-model ANOVA revealed a significant group-by-time interaction for changes in pressure pain thresholds over masseter (P<.01) and temporalis (P = .003) muscle latent TrPs and also for active mouth opening (P<.001) in favor of the manipulative and soft tissue groups. Between-group effect sizes were small. The application of an atlanto-occipital thrust manipulation or soft tissue technique targeted to the suboccipital muscles led to an immediate increase in pressure pain thresholds over latent TrPs in the masseter and temporalis muscles and an increase in maximum active mouth opening. Nevertheless, the effects of both interventions were small and future studies are required to elucidate the clinical relevance of these changes. Therapy, level 1b.J Orthop Sports Phys Ther 2010;40(5):310-317, Epub 12 April 2010. doi:10.2519/jospt.2010.3257.

Rationale and design of a multicenter randomized study for evaluating vascular function under uric acid control using the xanthine oxidase inhibitor, febuxostat: the PRIZE study.

PubMed

Oyama, Jun-Ichi; Tanaka, Atsushi; Sato, Yasunori; Tomiyama, Hirofumi; Sata, Masataka; Ishizu, Tomoko; Taguchi, Isao; Kuroyanagi, Takanori; Teragawa, Hiroki; Ishizaka, Nobukazu; Kanzaki, Yumiko; Ohishi, Mitsuru; Eguchi, Kazuo; Higashi, Yukihito; Yamada, Hirotsugu; Maemura, Koji; Ako, Junya; Bando, Yasuko K; Ueda, Shinichiro; Inoue, Teruo; Murohara, Toyoaki; Node, Koichi

2016-06-18

Xanthine oxidase inhibitors are anti-hyperuricemic drugs that decrease serum uric acid levels by inhibiting its synthesis. Xanthine oxidase is also recognized as a pivotal enzyme in the production of oxidative stress. Excess oxidative stress induces endothelial dysfunction and inflammatory reactions in vascular systems, leading to atherosclerosis. Many experimental studies have suggested that xanthine oxidase inhibitors have anti-atherosclerotic effects by decreasing in vitro and in vivo oxidative stress. However, there is only limited evidence on the clinical implications of xanthine oxidase inhibitors on atherosclerotic cardiovascular disease in patients with hyperuricemia. We designed the PRIZE study to evaluate the effects of febuxostat on a surrogate marker of cardiovascular disease risk, ultrasonography-based intima-media thickness of the carotid artery in patients with hyperuricemia. The study is a multicenter, prospective, randomized, open-label and blinded-endpoint evaluation (PROBE) design. A total of 500 patients with asymptomatic hyperuricemia (uric acid >7.0 mg/dL) and carotid intima-media thickness ≥1.1 mm will be randomized centrally to receive either febuxostat (10-60 mg/day) or non-pharmacological treatment. Randomization is carried out using the dynamic allocation method stratified according to age (<65, ≥65 year), gender, presence or absence of diabetes mellitus, serum uric acid (<8.0, ≥8.0 mg/dL), and carotid intima-media thickness (<1.3, ≥1.3 mm). In addition to administering the study drug, we will also direct lifestyle modification in all participants, including advice on control of body weight, sleep, exercise and healthy diet. Carotid intima-media thickness will be evaluated using ultrasonography performed by skilled technicians at a central laboratory. Follow-up will be continued for 24 months. The primary endpoint is percentage change in mean intima-media thickness of the common carotid artery 24 months after baseline, measured by carotid ultrasound imaging. PRIZE will be the first study to provide important data on the effects of febuxostat on atherosclerosis in patients with asymptomatic hyperuricemia. Trial Registration Unique trial Number, UMIN000012911 ( https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000015081&language=E ).

Feasibility study from a randomized controlled trial of standard closure of a stoma site vs biological mesh reinforcement.

PubMed

2016-09-01

Hernia formation occurs at closed stoma sites in up to 30% of patients. The Reinforcement of Closure of Stoma Site (ROCSS) randomized controlled trial is evaluating whether placement of biological mesh during stoma closure safely reduces hernia rates compared with closure without mesh, without increasing surgical or wound complications. This paper aims to report recruitment, deliverability and safety from the internal feasibility study. A multicentre, patient and assessor blinded, randomized controlled trial, delivered through surgical trainee research networks. A 90-patient internal feasibility study assessed recruitment, randomization, deliverability and early (30 day) safety of the novel surgical technique (ClinicalTrials.gov registration number NCT02238964). The feasibility study recruited 90 patients from the 104 considered for entry (45 to mesh, 45 to no mesh). Seven of eight participating centres randomized patients within 30 days of opening. Overall, 41% of stomas were created for malignant disease and 73% were ileostomies. No mesh-specific complications occurred. Thirty-one postoperative adverse events were experienced by 31 patients, including surgical site infection (9%) and postoperative ileus (6%). One mesh was removed for re-access to the abdominal cavity, for reasons unrelated to the mesh. Independent review by the Data Monitoring and Ethics Committee of adverse event data by treatment allocation found no safety concerns. Multicentre randomization to this trial of biological mesh is feasible, with no early safety concerns. Progression to the full Phase III trial has continued. ROCSS shows that trainee research networks can efficiently develop and deliver complex interventional surgical trials. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

"Will a Black Hole Eventually Swallow the Earth?" Fifth Graders' Interest in Questions from a Textbook, an Open Educational Resource, and Other Students' Questions

ERIC Educational Resources Information Center

Swirski, Hani; Baram-Tsabari, Ayelet

2015-01-01

Can questions sent to Open-Educational-Resource (OER) websites such as Ask-An-Expert serve as indicators for students' interest in science? This issue was examined using an online questionnaire which included an equal number of questions about the topics "space" and "nutrition" randomly selected from three different sources: a…

Reduction of Claustrophobia with Short-Bore versus Open Magnetic Resonance Imaging: A Randomized Controlled Trial

PubMed Central

Rief, Matthias; Martus, Peter; Klingebiel, Randolf; Asbach, Patrick; Klessen, Christian; Diederichs, Gerd; Wagner, Moritz; Teichgräber, Ulf; Bengner, Thomas; Hamm, Bernd; Dewey, Marc

2011-01-01

Background Claustrophobia is a common problem precluding MR imaging. The purpose of the present study was to assess whether a short-bore or an open magnetic resonance (MR) scanner is superior in alleviating claustrophobia. Methods Institutional review board approval and patient informed consent were obtained to compare short-bore versus open MR. From June 2008 to August 2009, 174 patients (139 women; mean age = 53.1 [SD 12.8]) with an overall mean score of 2.4 (SD 0.7, range 0 to 4) on the Claustrophobia Questionnaire (CLQ) and a clinical indication for imaging, were randomly assigned to receive evaluation by open or by short-bore MR. The primary outcomes were incomplete MR examinations due to a claustrophobic event. Follow-up was conducted 7 months after MR imaging. The primary analysis was performed according to the intention-to-treat strategy. Results With 33 claustrophobic events in the short-bore group (39% [95% confidence interval [CI] 28% to 50%) versus 23 in the open scanner group (26% [95% CI 18% to 37%]; P = 0.08) the difference was not significant. Patients with an event were in the examination room for 3.8 min (SD 4.4) in the short-bore and for 8.5 min (SD 7) in the open group (P = 0.004). This was due to an earlier occurrence of events in the short-bore group. The CLQ suffocation subscale was significantly associated with the occurrence of claustrophobic events (P = 0.003). New findings that explained symptoms were found in 69% of MR examinations and led to changes in medical treatment in 47% and surgery in 10% of patients. After 7 months, perceived claustrophobia increased in 32% of patients with events versus in only 11% of patients without events (P = 0.004). Conclusions Even recent MR cannot prevent claustrophobia suggesting that further developments to create a more patient-centered MR scanner environment are needed. Trial Registration ClinicalTrials.gov NCT00715806 PMID:21887259

Fluid lavage of open wounds (FLOW): a multicenter, blinded, factorial pilot trial comparing alternative irrigating solutions and pressures in patients with open fractures.

PubMed

Petrisor, Bradley; Sun, Xin; Bhandari, Mohit; Guyatt, Gordon; Jeray, Kyle J; Sprague, Sheila; Tanner, Stephanie; Schemitsch, Emil; Sancheti, Parag; Anglen, Jeff; Tornetta, Paul; Bosse, Michael; Liew, Susan; Walter, Stephen

2011-09-01

Open fractures are an important source of morbidity and are associated with delayed union, nonunion, and infection. Preventing infection through meticulous irrigation and debridement is an important goal in management, and different lavage fluids and irrigation techniques (e.g., high- or low-pressure lavage) have been described for this purpose. However, there are a limited number of randomized trials comparing irrigating solutions or irrigating technique. We compared the use of castile soap versus normal saline and high- versus low-pressure pulsatile lavage on the rates of reoperations and complications in patients with open fracture wounds. We conducted a multicenter, blinded, randomized 2 × 2 factorial pilot trial of 111 patients in whom an open fracture wound was treated with either castile soap solution or normal saline and either high- or low-pressure pulsatile lavage. The primary composite outcome of reoperation, measured at 12 months after initial operative procedure, included infection, wound healing problems, and nonunion. Planned reoperations were not included. Secondary outcomes included all infection, all wound healing problems, and nonunion as well as functional outcomes scores (EuroQol-5 dimensions and short form-12). Eighty-nine patients completed the 1-year follow-up. Among all patients, 13 (23%) in the castile soap group and 13 (24%) in the saline group had a primary outcome event (hazard ratio, 0.91, 95% confidence interval: 0.42-2.00, p = 0.52). Sixteen patients (28%) in the high-pressure group and 10 patients (19%) in the low-pressure group had a primary outcome event (hazard ratio 0.55, 95% confidence interval: 0.24-1.27, p = 0.17). Functional outcome scores showed no significant differences at any time point between groups. The fluid lavage of open wounds pilot randomized controlled trial demonstrated the possibility that the use of low pressure may decrease the reoperation rate for infection, wound healing problems, or nonunion. We have demonstrated the desirability and feasibility of a definitive trial examining the effects of alternative irrigation approaches.

A pilot randomized placebo-controlled trial of adjunctive aripiprazole for chronic PTSD in US military Veterans resistant to antidepressant treatment.

PubMed

Naylor, Jennifer C; Kilts, Jason D; Bradford, Daniel W; Strauss, Jennifer L; Capehart, Bruce P; Szabo, Steven T; Smith, Karen D; Dunn, Charlotte E; Conner, Kathryn M; Davidson, Jonathan R T; Wagner, Henry Ryan; Hamer, Robert M; Marx, Christine E

2015-05-01

Many individuals with post-traumatic stress disorder (PTSD) experience persistent symptoms despite pharmacological treatment with antidepressants. Several open-label monotherapy and adjunctive studies have suggested that aripiprazole (a second-generation antipsychotic) may have clinical utility in PTSD. However, there have been no randomized placebo-controlled trials of aripiprazole use for PTSD. We thus conducted a pilot randomized controlled trial of adjunctive aripiprazole versus placebo among Veterans with chronic PTSD serving in the US military since 11 September 2001 to assess the feasibility, safety, tolerability, and therapeutic potential of aripiprazole. Sixteen Veterans were randomized, and 14 completed at least 4 weeks of the study; 12 completed the entire 8-week trial. Outcome measures included the Clinician-Administered PTSD Scale (CAPS), PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores. Aripiprazole was well-tolerated in this cohort, and improvements in CAPS, PTSD Checklist, Beck Depression Inventory, Second Edition, and Positive and Negative Syndrome Scale scores were as hypothesized. Although CAPS change scores did not reach statistical significance, aripiprazole outperformed placebo by 9 points on the CAPS in the last observation carried forward analysis compared with the placebo group (n = 7 per group), and by 20 points in the group randomized to aripiprazole that completed the entire study (n = 5) compared with the placebo group (n = 7). Results suggest promise for aripiprazole as an adjunctive strategy for the treatment of PTSD.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nour, Ali, E-mail: ali.nour@polymtl.ca; Hydro Quebec, Montreal, Quebec, H2L 4P5; Massicotte, Bruno

This study is aimed at proposing a simple analytical model to investigate the post-cracking behaviour of FRC panels, using an arbitrary tension softening, stress crack opening diagram, as the input. A new relationship that links the crack opening to the panel deflection is proposed. Due to the stochastic nature of material properties, the random fibre distribution, and other uncertainties that are involved in concrete mix, this relationship is developed from the analysis of beams having the same thickness using the Monte Carlo simulation (MCS) technique. The softening diagrams obtained from direct tensile tests are used as the input for themore » calculation, in a deterministic way, of the mean load displacement response of round panels. A good agreement is found between the model predictions and the experimental results.« less

Studies of silicon pn junction solar cells

NASA Technical Reports Server (NTRS)

Lindholm, F. A.; Neugroschel, A.

1977-01-01

Modifications of the basic Shockley equations that result from the random and nonrandom spatial variations of the chemical composition of a semiconductor were developed. These modifications underlie the existence of the extensive emitter recombination current that limits the voltage over the open circuit of solar cells. The measurement of parameters, series resistance and the base diffusion length is discussed. Two methods are presented for establishing the energy bandgap narrowing in the heavily-doped emitter region. Corrections that can be important in the application of one of these methods to small test cells are examined. Oxide-charge-induced high-low-junction emitter (OCI-HLE) test cells which exhibit considerably higher voltage over the open circuit than was previously seen in n-on-p solar cells are described.

Effectiveness of barnidipine 10 or 20 mg plus losartan 50-mg combination versus losartan 100-mg monotherapy in patients with essential hypertension not controlled by losartan 50-mg monotherapy: A 12-week, multicenter, randomized, open-label, parallel-group study.

PubMed

Parati, Gianfranco; Giglio, Alessia; Lonati, Laura; Destro, Maurizio; Ricci, Alessandra Rossi; Cagnoni, Francesca; Pini, Claudio; Venco, Achille; Maresca, Andrea Maria; Monza, Michela; Grandi, Anna Maria; Omboni, Stefano

2010-07-01

Increasing the dose or adding a second antihypertensive agent are 2 possible therapeutic choices when blood pressure (BP) is poorly controlled with monotherapy. This study investigated the effectiveness and tolerability of barnidipine 10 or 20 mg added to losartan 50 mg versus losartan 100 mg alone in patients with mild to moderate essential hypertension whose BP was uncontrolled by losartan 50-mg monotherapy. This was a 12-week, multicenter, randomized, open-label, parallel-group study. Eligible patients (aged 30-74 years) had uncontrolled hypertension, defined as office sitting diastolic BP (DBP) > or =90 mm Hg and/or systolic BP (SBP) > or =140 mm Hg, and mean daytime DBP > or =85 mm Hg and/or SBP > or =135 mm Hg. All were being treated with losartan 50 mg at enrollment. After a 1-week run-in period while taking losartan 50 mg, patients were randomly assigned to 6 weeks of treatment with open-label barnidipine 10 mg plus losartan 50 mg or losartan 100-mg monotherapy. At the end of this period, patients with uncontrolled BP had barnidipine doubled to 20 mg and continued for an additional 6 weeks, whereas patients not achieving control on treatment with losartan 100 mg were discontinued. Office BP was measured at each visit, whereas 24-hour ambulatory BP monitoring (ABPM) was performed at randomization and at the final visit (ie, after 12 weeks of treatment, or at 6 weeks for patients not controlled on losartan 100 mg). The intent-to-treat population included all randomized patients who received at least one dose of study treatment and had valid ABPM recordings at baseline and the final visit. The primary end point was the change in daytime DBP between baseline and 12 weeks of treatment, compared between the combination treatment and monotherapy. Adverse events (AEs) were evaluated during each study visit. A total of 93 patients were enrolled (age range, 30-75 years; 60% [56/93] men). After the 1-week run-in period, 68 patients were randomly assigned to 6 weeks of treatment with open-label barnidipine 10 mg plus losartan 50 mg (n = 34) or losartan 100-mg monotherapy (n = 34). A total of 53 patients were evaluable (barnidipine plus losartan, n = 28; losartan, n = 25). After 6 weeks of treatment, 18 patients in the combination treatment group (64.3%) had their dose of barnidipine doubled from 10 to 20 mg because BP was not normalized by treatment, whereas 8 patients in the losartan group (32.0%) were discontinued for the same reason. The between-treatment difference (losartan alone - combination treatment) for changes from baseline in daytime DBP was -1.7 mm Hg (95% CI, -5.8 to 2.4 mm Hg; P = NS). A similar result was observed for daytime SBP (-3.2 mm Hg; 95% CI, -8.1 to 1.7 mm Hg; P = NS). Likewise, no significant differences were found for nighttime values (mean [95% CI] DBP, 0.5 mm Hg [-3.7 to 4.7 mm Hg]; SBP, 1.5 mm Hg [-4.1 to 7.1 mm Hg]) or 24-hour values (DBP, -0.9 mm Hg [-4.8 to 2.9 mm Hg]; SBP, -1.6 mm Hg [-5.9 to 2.7 mm Hg]). Combination treatment was associated with a significantly higher rate of SBP responder patients (ie, <140 mm Hg or a reduction of > or =20 mm Hg) compared with monotherapy (82.1% [23/28] vs 56.0% [14/25]; P = 0.044). Drug-related AEs were reported in 4 patients taking combination treatment (total of 7 AEs, including 2 cases of peripheral edema and 1 each of tachycardia, atrial flutter, tinnitus, confusion, and polyuria) and in 2 patients taking losartan alone (total of 2 AEs, both tachycardia). This open-label, parallel-group study found that there was no significant difference in the BP-lowering effect of barnidipine 10 or 20 mg in combination with losartan 50 mg compared with losartan 100-mg monotherapy in these patients with essential hypertension previously uncontrolled by losartan 50-mg monotherapy. However, the percentage of responders for SBP was significantly higher with the combination. Both treatments were generally well tolerated. European Union Drug Regulating Authorities Clinical Trials (EudraCT) no. 2006-001469-41. 2010 Excerpta Medica Inc. All rights reserved.

Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer

PubMed Central

Pigazzi, Alessio; Marshall, Helen; Croft, Julie; Corrigan, Neil; Copeland, Joanne; Quirke, Phil; West, Nick; Rautio, Tero; Thomassen, Niels; Tilney, Henry; Gudgeon, Mark; Bianchi, Paolo Pietro; Edlin, Richard; Hulme, Claire; Brown, Julia

2017-01-01

Importance Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy. Objective To compare robotic-assisted vs conventional laparoscopic surgery for risk of conversion to open laparotomy among patients undergoing resection for rectal cancer. Design, Setting, and Participants Randomized clinical trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. Recruitment of patients was from January 7, 2011, to September 30, 2014, follow-up was conducted at 30 days and 6 months, and final follow-up was on June 16, 2015. Interventions Patients were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection, performed by either high (upper rectum) or low (total rectum) anterior resection or abdominoperineal resection (rectum and perineum). Main Outcomes and Measures The primary outcome was conversion to open laparotomy. Secondary end points included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes. Results Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%: 19 of 236 patients (8.1%) in the robotic-assisted laparoscopic group and 28 of 230 patients (12.2%) in the conventional laparoscopic group (unadjusted risk difference = 4.1% [95% CI, −1.4% to 9.6%]; adjusted odds ratio = 0.61 [95% CI, 0.31 to 1.21]; P = .16). The overall CRM+ rate was 5.7%; CRM+ occurred in 14 (6.3%) of 224 patients in the conventional laparoscopic group and 12 (5.1%) of 235 patients in the robotic-assisted laparoscopic group (unadjusted risk difference = 1.1% [95% CI, −3.1% to 5.4%]; adjusted odds ratio = 0.78 [95% CI, 0.35 to 1.76]; P = .56). Of the other 8 reported prespecified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups. Results Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%. The overall CRM+ rate was 5.7%. Of the other 8 reported prespecified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups. End Point No. With Outcome/Total No. (%) Unadjusted Risk Difference (95% CI), % Adjusted Odds Ratio (95% CI) P Value Conventional Laparoscopy Robotic-Assisted Laparoscopy Conversion to open laparotomy 28/230 (12.2) 19/236 (8.1) 4.1 (−1.4 to 9.6) 0.61 (0.31-1.21) .16 CRM+ 14/224 (6.3) 12/235 (5.1) 1.1 (−3.1 to 5.4) 0.78 (0.35-1.76) .56 Conclusions and Relevance Among patients with rectal adenocarcinoma suitable for curative resection, robotic-assisted laparoscopic surgery, as compared with conventional laparoscopic surgery, did not significantly reduce the risk of conversion to open laparotomy. These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection. Trial Registration isrctn.org Identifier: ISRCTN80500123 PMID:29067426

The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE): study protocol for a randomized controlled trial.

PubMed

Azuara-Blanco, Augusto; Burr, Jennifer M; Cochran, Claire; Ramsay, Craig; Vale, Luke; Foster, Paul; Friedman, David; Quayyum, Zahidul; Lai, Jimmy; Nolan, Winnie; Aung, Tin; Chew, Paul; McPherson, Gladys; McDonald, Alison; Norrie, John

2011-05-23

Glaucoma is the leading cause of irreversible blindness. Although primary open-angle glaucoma is more common, primary angle-closure glaucoma (PACG) is more likely to result in irreversible blindness. By 2020, 5·3 million people worldwide will be blind because of PACG. The current standard care for PACG is a stepped approach of a combination of laser iridotomy surgery (to open the drainage angle) and medical treatment (to reduce intraocular pressure). If these treatments fail, glaucoma surgery (eg, trabeculectomy) is indicated. It has been proposed that, because the lens of the eye plays a major role in the mechanisms leading to PACG, early clear lens extraction will improve glaucoma control by opening the drainage angle. This procedure might reduce the need for drugs and glaucoma surgery, maintain good visual acuity, and improve quality of life compared with standard care.EAGLE aims to evaluate whether early lens extraction improves patient-reported, clinical outcomes, and cost-effectiveness, compared with standard care. EAGLE is a multicentre pragmatic randomized trial. All people presenting to the recruitment centres in the UK and east Asia with newly diagnosed PACG and who are at least 50 years old are eligible.The primary outcomes are EQ-5D, intraocular pressure, and incremental cost per quality adjusted life year (QALY) gained. Other outcomes are: vision and glaucoma-specific patient-reported outcomes, visual acuity, visual field, angle closure, number of medications, additional surgery (e.g., trabeculectomy), costs to the health services and patients, and adverse events.A single main analysis will be done at the end of the trial, after three years of follow-up. The analysis will be based on all participants as randomized (intention to treat). 400 participants (200 in each group) will be recruited, to have 90% power at 5% significance level to detect a difference in EQ-5D score between the two groups of 0·05, and a mean difference in intraocular pressure of 1·75 mm Hg. The study will have 80% power to detect a difference of 15% in the glaucoma surgery rate. ISRCTN44464607.

Laparoscopic bridging vs. anatomic open reconstruction for midline abdominal hernia mesh repair [LABOR]: single-blinded, multicenter, randomized, controlled trial on long-term functional results.

PubMed

Stabilini, Cesare; Bracale, Umberto; Pignata, Giusto; Frascio, Marco; Casaccia, Marco; Pelosi, Paolo; Signori, Alessio; Testa, Tommaso; Rosa, Gian Marco; Morelli, Nicola; Fornaro, Rosario; Palombo, Denise; Perotti, Serena; Bruno, Maria Santina; Imperatore, Mikaela; Righetti, Carolina; Pezzato, Stefano; Lazzara, Fabrizio; Gianetta, Ezio

2013-10-28

Re-approximation of the rectal muscles along the midline is recommended by some groups as a rule for incisional and ventral hernia repairs. The introduction of laparoscopic repair has generated a debate because it is not aimed at restoring abdominal wall integrity but instead aims just to bridge the defect. Whether restoration of the abdominal integrity has a real impact on patient mobility is questionable, and the available literature provides no definitive answer. The present study aims to compare the functional results of laparoscopic bridging with those of re-approximation of the rectal muscle in the midline as a mesh repair for ventral and incisional abdominal defect through an "open" access. We hypothesized that, for the type of defect suitable for a laparoscopic bridging, the effect of an anatomical reconstruction is near negligible, thus not a fixed rule. The LABOR trial is a multicenter, prospective, two-arm, single-blinded, randomized trial. Patients of more than 60 years of age with a defect of less than 10 cm at its greatest diameter will be randomly submitted to open Rives or laparoscopic defect repair. All the participating patients will have a preoperative evaluation of their abdominal wall strength and mobility along with volumetry, respiratory function test, intraabdominal pressure and quality of life assessment.The primary outcome will be the difference in abdominal wall strength as measured by a double leg-lowering test performed at 12 months postoperatively. The secondary outcomes will be the rate of recurrence and changes in baseline abdominal mobility, respiratory function tests, intraabdominal pressure, CT volumetry and quality of life at 6 and 12 months postoperatively. The study will help to define the most suitable treatment for small-medium incisional and primary hernias in patients older than 60 years. Given a similar mid-term recurrence rate in both groups, if the trial shows no differences among treatments (acceptance of the null-hypothesis), then the choice of whether to submit a patient to one intervention will be made on the basis of cost and the surgeon's experience. Current Controlled Trials ISRCTN93729016.

Association between open or closed reduction and avascular necrosis in developmental dysplasia of the hip

PubMed Central

Wang, Ya-Jie; Yang, Fan; Wu, Qi-Jun; Pan, Shi-Nong; Li, Lian-Yong

2016-01-01

Abstract Background: The risk of avascular necrosis of the femoral head (AVN) after treatment of developmental dysplasia of the hip is associated with the method of reduction. Some authors have suggested that open reduction is a risk factor for AVN; however, this is controversial. To our knowledge, a quantitative comparison of the incidence of AVN between closed and open reduction has not been conducted. Methods: Published studies were identified by searching PubMed, EMBASE, and the Cochrane Library up to May, 2015, focusing on the incidence of AVN after closed or open reduction for developmental dysplasia of the hip in children aged <3 years. Patients were age-matched who were treated by either closed or open reduction, but without pelvic or femoral osteotomy. Two authors independently assessed eligibility and abstracted data. Discrepancies were discussed and resolved by consensus. We pooled the odds ratios (ORs) and 95% confidence intervals (95%CIs) from individual studies using a random-effects model and evaluated heterogeneity and publication bias. Results: Nine retrospective studies were included in this analysis. The pooled OR for comparing open reduction with closed reduction for all grades of AVN was 2.26 (95%CI = 1.21–4.22), with moderate heterogeneity (I2 = 44.7%, P = 0.107). The pooled OR for grades II to IV AVN was 2.46 (95%CI = 0.93–6.51), with high heterogeneity (I2 = 69.6%, P = 0.003). A significant association was also found for the further surgery between open and closed reduction, with a pooled OR of 0.30 (95%CI = 0.15–0.60) and moderate heterogeneity (I2 = 46.4%, P = 0.133). No evidence of publication bias or significant heterogeneity between subgroups was detected by meta-regression analyses. Conclusion: Findings from this meta-analysis suggest that open reduction is a risk factor for the development of AVN compared with closed treatment. Future studies are warranted to investigate how open reduction combined with pelvis and/or femoral osteotomy affects the incidence of AVN. PMID:27442664

Harmonic versus LigaSure hemostasis technique in thyroid surgery: A meta-analysis

PubMed Central

Upadhyaya, Arun; Hu, Tianpeng; Meng, Zhaowei; Li, Xue; He, Xianghui; Tian, Weijun; Jia, Qiang; Tan, Jian

2016-01-01

Harmonic scalpel and LigaSure vessel sealing systems have been suggested as options for saving surgical time and reducing postoperative complications. The aim of the present meta-analysis was to compare surgical time, postoperative complications and other parameters between them in for the open thyroidectomy procedure. Studies were retrieved from MEDLINE, Cochrane Library, EMBASE and ISI Web of Science until December 2015. All the randomized controlled trials (RCTs) comparing Harmonic scalpel and LigaSure during open thyroidectomy were selected. Following data extraction, statistical analyses were performed. Among the 24 studies that were evaluated for eligibility, 7 RCTs with 981 patients were included. The Harmonic scalpel significantly reduced surgical time compared with LigaSure techniques (8.79 min; 95% confidence interval, −15.91 to −1.67; P=0.02). However, no significant difference was observed for the intraoperative blood loss, postoperative blood loss, duration of hospital stay, thyroid weight and serum calcium level postoperatively in either group. The present meta-analysis indicated superiority of Harmonic Scalpel only in terms of surgical time compared with LigaSure hemostasis techniques in open thyroid surgery. PMID:27446546

Validity of temporomandibular disorder examination procedures for assessment of temporomandibular joint status.

PubMed

Schmitter, Marc; Kress, Bodo; Leckel, Michael; Henschel, Volkmar; Ohlmann, Brigitte; Rammelsberg, Peter

2008-06-01

This hypothesis-generating study was performed to determine which items in the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and additional diagnostic tests have the best predictive accuracy for joint-related diagnoses. One hundred forty-nine TMD patients and 43 symptom-free subjects were examined in clinical examinations and with magnetic resonance imaging (MRI). The importance of each variable of the clinical examination for correct joint-related diagnosis was assessed by using MRI diagnoses. For this purpose, "random forest" statistical software (based on classification trees) was used. Maximum unassisted jaw opening, maximum assisted jaw opening, history of locked jaw, joint sound with and without compression, joint pain, facial pain, pain on palpation of the lateral pterygoid area, and overjet proved suitable for distinguishing between subtypes of joint-related TMD. Measurement of excursion, protrusion, and midline deviation were less important. The validity of clinical TMD examination procedures can be enhanced by using the 16 variables of greatest importance identified in this study. In addition to other variables, maximum unassisted and assisted opening and a history of locked jaw were important when assessing the status of the TMJ.

Feasibility of eyes open alpha power training for mental enhancement in elite gymnasts.

PubMed

Dekker, Marian K J; van den Berg, Berber R; Denissen, Ad J M; Sitskoorn, Margriet M; van Boxtel, Geert J M

2014-01-01

This study focuses on a novel, easy to use and instruction-less method for mental training in athletes. Previous findings suggest that particular mental capacities are needed for achieving peak performance; including attentional control, focus, relaxation and positive affect. Electroencephalography (EEG) alpha brain activity has been associated with neural inhibition during processes of selective attention, for improving efficiency in information processing. Here we hypothesised that eyes open alpha power training by music teaches athletes to (1) learn to self-regulate their brain activity, and (2) learn to increase their baseline alpha power, herewith improving mental capacities such as focusing the allocation of attention. The study was double-blind and placebo-controlled. Twelve elite gymnasts were either given eyes open alpha power training or random beta power training (controls). Results indicate small improvements in sleep quality, mental and physical shape. In our first attempt at getting a grip on mental capacities in athletes, we think this novel training method can be promising. Because gymnastics is one of the most mentally demanding sports, we value even small benefits for the athlete and consider them indicative for future research.

What is the best reconstruction method after distal gastrectomy for gastric cancer?

PubMed

Lee, Moon-Soo; Ahn, Sang-Hoon; Lee, Ju-Hee; Park, Do Joong; Lee, Hyuk-Joon; Kim, Hyung-Ho; Yang, Han-Kwang; Kim, Nayoung; Lee, Won Woo

2012-06-01

We performed this prospective randomized study to evaluate what is the best reconstruction method after distal gastrectomy for gastric cancer. One hundred fifty-nine patients who underwent laparoscopy-assisted or open gastrectomy for gastric cancer were analyzed from March 2006 to August 2007. Billroth I (B-I) anastomosis, Billroth II (B-II) with Braun anastomosis, and Roux-en-Y (R-Y) anastomosis were applied randomly. Additionally, the patients were divided into two groups based on treatment type: laparoscopic and open operation. Endoscopy and hepatobiliary scans were performed to investigate gastric stasis and enterogastric reflux. The Gastrointestinal Quality of Life Index (GIQLI) was used to evaluate postoperative quality of life, and the hematologic test was used to assess nutritional aspect. Endoscopy revealed that reflux after the R-Y anastomosis procedure was significantly less frequent than after the other anastomosis types at 12 months. Comparison of the GIQLI and the nutritional parameters between the reconstruction types revealed that there were no differences, but a significantly higher GIQLI score was observed in the laparoscopic group immediately following the procedure (P = 0.042). R-Y anastomosis is superior to B-I and B-II with Braun anastomosis in terms of frequency of bile reflux, despite the fact that there is no difference in the postoperative quality-of-life index and nutritional status between reconstructive procedures. The laparoscopic approach is the better option than open surgery in terms of QOL in the immediate postoperative period.

Randomized clinical trial of bright light therapy for antepartum depression: preliminary findings.

PubMed

Epperson, C Neill; Terman, Michael; Terman, Jiuan Su; Hanusa, Barbara H; Oren, Dan A; Peindl, Kathleen S; Wisner, Katherine L

2004-03-01

Bright light therapy was shown to be a promising treatment for depression during pregnancy in a recent open-label study. In an extension of this work, we report findings from a double-blind placebo-controlled pilot study. Ten pregnant women with DSM-IV major depressive disorder were randomly assigned from April 2000 to January 2002 to a 5-week clinical trial with either a 7000 lux (active) or 500 lux (placebo) light box. At the end of the randomized controlled trial, subjects had the option of continuing in a 5-week extension phase. The Structured Interview Guide for the Hamilton Depression Scale-Seasonal Affective Disorder Version was administered to assess changes in clinical status. Salivary melatonin was used to index circadian rhythm phase for comparison with antidepressant results. Although there was a small mean group advantage of active treatment throughout the randomized controlled trial, it was not statistically significant. However, in the longer 10-week trial, the presence of active versus placebo light produced a clear treatment effect (p =.001) with an effect size (0.43) similar to that seen in antidepressant drug trials. Successful treatment with bright light was associated with phase advances of the melatonin rhythm. These findings provide additional evidence for an active effect of bright light therapy for antepartum depression and underscore the need for an expanded randomized clinical trial.

Robot-assisted remote echocardiographic examination and teleconsultation: a randomized comparison of time to diagnosis with standard of care referral approach.

PubMed

Boman, Kurt; Olofsson, Mona; Berggren, Peter; Sengupta, Partho P; Narula, Jagat

2014-08-01

The strategy using cardiological consultation in addition to the robot-assisted remote echocardiography at a distance was tested in a prospective, randomized open-label trial to evaluate its feasibility and to define its clinical value in a rural area. The present study involved 1 primary healthcare center in the north of Sweden, 135 miles from the hospital where the echocardiograms and the cardiology teleconsultation were performed long distance in real time. Nineteen patients were randomized to remote consultation and imaging, and 19 to the standard of care consultation. The total process time was significantly reduced in the former arm (median 114 days vs. 26.5 days; p < 0.001). The time from randomization until attaining a specialist consultation was also significantly reduced (p < 0.001). The patients' satisfaction was reassuring; they considered that the remote consultation strategy offered an increased rapidity of diagnosis and the likelihood of receiving faster management compared with the standard of care at the primary healthcare center. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A pilot randomized controlled trial of deprescribing.

PubMed

Beer, Christopher; Loh, Poh-Kooi; Peng, Yan Gee; Potter, Kathleen; Millar, Alasdair

2011-04-01

Polypharmacy and adverse drug reactions are frequent and important among older people. Few clinical trials have evaluated systematic withdrawal of medications among older people. This small, open, study was conducted to determine the feasibility of a randomized controlled deprescribing trial. Ten volunteers living in the community (recruited by media advertising) and 25 volunteers living in residential aged-care facilities (RCFs) were randomized to intervention or control groups. The intervention was gradual withdrawal of one target medication. The primary outcome was the number of intervention participants in whom medication withdrawal could be achieved. Other outcomes measures were quality of life, medication adherence, sleep quality, and cognitive impairment. Participants were aged 80 ± 11 years and were taking 9 ± 2 medications. Fifteen participants commenced medication withdrawal and all ceased or reduced the dose of their target medication. Two subjects withdrew; one was referred for clinical review, and one participant declined further dose reductions. A randomized controlled trial of deprescribing was acceptable to participants. Recruitment in RCFs is feasible. Definitive trials of deprescribing are required.

Development of Fetal Yawn Compared with Non-Yawn Mouth Openings from 24–36 Weeks Gestation

PubMed Central

Reissland, Nadja; Francis, Brian; Mason, James

2012-01-01

Background Although some research suggests that fetuses yawn, others disagree arguing that is it simple mouth opening. Furthermore there is no developmental account of fetal yawning compared with simple mouth opening. The aim of the present study was to establish in a repeated measures design the development of fetal yawning compared with simple mouth opening. Methodology/Findings Video recordings were made of the fetal face and upper torso visualized by means of 4D full frontal or facial profile ultrasound recordings. Fifteen healthy fetuses were scanned four times at 24, 28, 32 and 36 weeks gestation. Yawning was distinguished from non-yawning in terms of the length of time it took to reach the apex of the mouth stretch, with yawns being defined as more than 50% of the total time observed. To assess changes in frequency, a Poisson mixed effects model was fitted to the count of number of yawn and simple mouth opening events with age and gender as fixed effects, and person as a random effect. For both yawns and simple mouth openings a smooth varying age effect was significant. The number of yawns observed declined with age from 28 weeks gestation, whereas simple mouth openings were less frequent and the decline was observed from 24 weeks. Gender was not significant either for yawn and simple mouth openings. Conclusions/Significance Yawning can be reliably distinguished from other forms of mouth opening with the potential of using yawning as an index of fetal healthy development. PMID:23185638

Surface Wave Dispersion Measurements and Tomography From Ambient Seismic Noise in China

DTIC Science & Technology

2007-12-20

Recovering the Green’s function from field - field correlations in an open scattering medium (L), J. Acoust. Soc. Amer. 113 (6), 2973- 2976, 2003. Eagle, D...The basic approach can be traced back much earlier studies of random fields in seismology (Aki, 1957; Toksoz, 1964; Claerbout, 1968), in...Seismic Network (CNDSN), Center of China Digital Seismic Network (CCDSN) stations, and China Seismic Network ( CSN ). We refer here as China National

Evaluation of Crushed Tablet for Oral Administration and the Effect of Food on Apixaban Pharmacokinetics in Healthy Adults.

PubMed

Song, Yan; Chang, Ming; Suzuki, Akiyuki; Frost, Robert J A; Kelly, Anne; LaCreta, Frank; Frost, Charles

2016-07-01

These studies evaluate the relative bioavailability of crushed apixaban tablets and the effect of food on apixaban pharmacokinetic properties. An open-label, randomized, crossover study in 33 healthy adults compared the bioavailability of 2 × 5-mg apixaban tablets administered whole (reference), crushed and suspended in 30 mL of water, and crushed and mixed with 30 g of applesauce. A second open-label, randomized, crossover study in 22 healthy adults compared apixaban 1 × 5-mg tablet administered when fasted (reference) or immediately after consumption of a high-fat, high-calorie meal. Point estimates and 90% CIs for geometric mean ratios were generated for Cmax, AUC0-∞, and AUC0-t. Cmax and AUC met bioequivalence criteria for crushed tablets in water. Cmax and AUC decreased by 21.1% and 16.4%, respectively, with the lower bound of the CIs falling below the bioequivalence criteria for crushed tablets with applesauce. Similarly, administration of whole tablets with a high-fat, high-calorie meal reduced apixaban Cmax and AUC by 14.9% and 20.1%, respectively. The exposure reductions in both studies were considered not clinically significant. Apixaban tablets can be administered crushed or whole, with or without food. The results of these alternative methods of administration support their use in patients who have difficulty swallowing tablets. ClinicalTrials.gov identifiers: NCT02101112 and NCT01437839. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Different effect of psyllium and guar dietary supplementation on blood pressure control in hypertensive overweight patients: a six-month, randomized clinical trial.

PubMed

Cicero, Arrigo F G; Derosa, Giuseppe; Manca, Marco; Bove, Marilisa; Borghi, Claudio; Gaddi, Antonio V

2007-08-01

In the setting of a six-month, open-label clinical trial, 141 consecutively enrolled, hypertensive, overweight patients were randomized to the oral ingestion of psyllium powder or guar gum 3.5 gr t.i.d., to be taken 20 min before the main two meals, or to standard diet. Both fibers improved significantly BMI, FPG, FPI, HOMA Index, HbA1c, LDL-C, and ApoB. Psyllium supplementation only exerted a significant improvement in plasma TG concentration, in SBP and DBP. In our study, six-month supplementation with psyllium fiber, but not with guar fiber nor standard diet, appears to significantly reduce both SBP and DBP in hypertensive overweight subjects.

Meta-analysis of Prolene Hernia System mesh versus Lichtenstein mesh in open inguinal hernia repair.

PubMed

Sanjay, Pandanaboyana; Watt, David G; Ogston, Simon A; Alijani, Afshin; Windsor, John A

2012-10-01

This study was designed to systematically analyse all published randomized clinical trials comparing the Prolene Hernia System (PHS) mesh and Lichtenstein mesh for open inguinal hernia repair. A literature search was performed using the Cochrane Colorectal Cancer Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials in the Cochrane Library, MEDLINE, Embase and Science Citation Index Expanded. Randomized trials comparing the Lichtenstein Mesh repair (LMR) with the Prolene Hernia System were included. Statistical analysis was performed using Review Manager Version 5.1 software. The primary outcome measures were hernia recurrence and chronic pain after operation. Secondary outcome measures included surgical time, peri-operative complications, time to return to work, early and long-term postoperative complications. Six randomized clinical trials were identified as suitable, containing 1313 patients. There was no statistical difference between the two types of repair in operation time, time to return to work, incidence of chronic groin pain, hernia recurrence or long-term complications. The PHS group had a higher rate of peri-operative complications, compared to Lichtenstein mesh repair (risk ratio (RR) 0.71, 95% confidence interval 0.55-0.93, P=0.01). The use of PHS mesh was associated with an increased risk of peri-operative complications compared to LMR. Both mesh repair techniques have comparable short- and long-term outcomes. Copyright © 2012 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Randomized comparison of postoperative short-term and mid-term complications between T-tube and primary closure after CBD exploration.

PubMed

Muzaffar, Iqbal; Zula, Pai; Yimit, Yusp; Jaan, Ajim Tuergan; Wen, Hao

2014-11-01

To compare the postoperative short-term and mid-term complications in patients who underwent CBD exploration and closure by using T-tube or primary closure. Prospective randomized clinical trial. Hepatobiliary Department of First Affiliated Hospital of Xinjiang Medical University, Urumqi, China, from August 2009 to March 2013. A total of 148 consecutive patients with Common Bile Duct Stones (CBDS) and CBD dilation were enrolled in this randomized study to undergo open cholecystectomy with CBD exploration. Pre-operative findings, postoperative short-term complications, postoperative follow-up (mid-term), and hospital stay were recorded and analyzed. A T-tube was inserted in 76 (51.35%) patients and the primary closure was done in 72 (48.64%) patients. There were no differences in the demographic characteristics and clinical presentations between the two groups. Compared with the T-tube group 8.97 ± 1.629 days, the postoperative stay in primary closure 5.34 ± 1.25 days was significantly shorter (p < 0.01). The incidence of overall postoperative short-term complications and mid-term complications were statistically but not significantly lower in the primary closure group (9.7%) than that in T-tube group (17.10%, p=0.189). Complications in the primary closure group were lower than that in T-tube group but there was no significant statistical difference. So during open surgery for CBD stones, primary closure of CBD appeared safe and effective with shorter hospital stays and less complications.

Irrigation solutions in open fractures of the lower extremities: evaluation of isotonic saline and distilled water.

PubMed

Olufemi, Olukemi Temiloluwa; Adeyeye, Adeolu Ikechukwu

2017-01-01

Open fractures are widely considered as orthopaedic emergencies requiring immediate intervention. The initial management of these injuries usually affects the ultimate outcome because open fractures may be associated with significant morbidity. Wound irrigation forms one of the pivotal principles in the treatment of open fractures. The choice of irrigation fluid has since been a source of debate. This study aimed to evaluate and compare the effects of isotonic saline and distilled water as irrigation solutions in the management of open fractures of the lower extremities. Wound infection and wound healing rates using both solutions were evaluated. This was a prospective hospital-based study of 109 patients who presented to the Accident and Emergency department with open lower limb fractures. Approval was sought and obtained from the Ethics Committee of the Hospital. Patients were randomized into either the isotonic saline (NS) or the distilled water (DW) group using a simple ballot technique. Twelve patients were lost to follow-up, while 97 patients were available until conclusion of the study. There were 50 patients in the isotonic saline group and 47 patients in the distilled water group. Forty-one (42.3%) of the patients were in the young and economically productive strata of the population. There was a male preponderance with a 1.7:1 male-to-female ratio. The wound infection rate was 34% in the distilled water group and 44% in the isotonic saline group (p = 0.315). The mean time ± SD to wound healing was 2.7 ± 1.5 weeks in the distilled water group and 3.1 ± 1.8 weeks in the isotonic saline group (p = 0.389). It was concluded from this study that the use of distilled water compares favourably with isotonic saline as an irrigation solution in open fractures of the lower extremities. © The Authors, published by EDP Sciences, 2017.

Open-label dose optimization of methylphenidate modified release long acting (MPH-LA): a post hoc analysis of real-life titration from a 40-week randomized trial.

PubMed

Huss, Michael; Ginsberg, Ylva; Arngrim, Torben; Philipsen, Alexandra; Carter, Katherine; Chen, Chien-Wei; Gandhi, Preetam; Kumar, Vinod

2014-09-01

In the management of attention-deficit hyperactivity disorder (ADHD) in adults it is important to recognize that individual patients respond to a wide range of methylphenidate doses. Studies with methylphenidate modified release long acting (MPH-LA) in children have reported the need for treatment optimization for improved outcomes. We report the results from a post hoc analysis of a 5-week dose optimization phase from a large randomized, placebo-controlled, multicenter 40-week study (9-week double-blind dose confirmation phase, 5-week open-label dose optimization phase, and 26-week double-blind maintenance of effect phase). Patients entering the open-label dose optimization phase initiated treatment with MPH-LA 20 mg/day; up/down titrated to their optimal dose (at which there was balance between control of symptoms and side effects) of 40, 60, or 80 mg/day in increments of 20 mg/week by week 12 or 13. Safety was assessed by monitoring the adverse events (AEs) and serious AEs. Efficacy was assessed by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, Attention-Deficit Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) and Sheehan Disability Scale (SDS) total scores. At the end of the dose confirmation phase, similar numbers of patients were treated optimally with each of the 40, 60, and 80 mg/day doses (152, 177, and 160, respectively) for MPH-LA. Mean improvement from baseline in the dose confirmation phase in total scores of DSM-IV ADHD RS and SDS were 23.5 ± 9.90 and 9.7 ± 7.36, respectively. Dose optimization with MPH-LA (40, 60, or 80 mg/day) improved treatment outcomes and was well-tolerated in adult ADHD patients.

EffenDys-Fentanyl Buccal Tablet for the Relief of Episodic Breathlessness in Patients With Advanced Cancer: A Multicenter, Open-Label, Randomized, Morphine-Controlled, Crossover, Phase II Trial.

PubMed

Simon, Steffen T; Kloke, Marianne; Alt-Epping, Bernd; Gärtner, Jan; Hellmich, Martin; Hein, Rebecca; Piel, Maren; Cornely, Oliver A; Nauck, Friedemann; Voltz, Raymond

2016-11-01

Episodic breathlessness is a frequent and burdensome symptom in cancer patients but pharmacological treatment is limited. To determine time to onset, efficacy, feasibility, and safety of transmucosal fentanyl in comparison to immediate-release morphine for the relief of episodic breathlessness. Phase II, investigator-initiated, multicenter, open-label, randomized, morphine-controlled, crossover trial with open-label titration of fentanyl buccal tablet (FBT) in inpatients with incurable cancer. The primary outcome was time to onset of meaningful breathlessness relief. Secondary outcomes were efficacy (breathlessness intensity difference at 10 and 30 minutes; sum of breathlessness intensity difference at 15 and 60 minutes), feasibility, and safety. Study was approved by local ethics committees. Twenty-five of 1341 patients were eligible, 10 patients agreed to participate (four female, mean age 58 ± 11, mean Karnofsky score 67 ± 11). Two patients died before final visits and two patients dropped-out because of disease progression leaving six patients for analysis with 61 episodes of breathlessness. Mean time to onset was for FBT 12.7 ± 10.0 and for immediate-release morphine 23.6 ± 15.1 minutes with a mean difference of -10.9 minutes (95% CI = -24.5 to 2.7, P = 0.094). Efficacy measures were predominately in favor for FBT. Both interventions were safe. Feasibility failed because of too much study demands for a very ill patient group. The description of a faster and greater relief of episodic breathlessness by transmucosal fentanyl versus morphine justifies further evaluation by a full-powered trial. Copyright © 2016. Published by Elsevier Inc.

The Immediate and Delayed Post-Debridement Effects on Tissue Bacterial Wound Counts of Hypochlorous Acid Versus Saline Irrigation in Chronic Wounds.

PubMed

Hiebert, John M; Robson, Martin C

2016-01-01

Introduction: Wound debridement is considered essential in chronic wound management. Hypochlorous acid has been shown to be an effective agent in reducing wound bacterial counts in open wounds. Ultrasound-enabled wound debridement is an effective and efficient method of debridement. This study compared ultrasound irrigation with hypochlorous acid versus saline irrigation for wound debridement on pre- and postoperative wounds and determined regrowth of bacteria over 1 week period of time. Finally, the outcome of definitive wound closure of the clinically clean-appearing wounds was recorded. Methods: Seventeen consenting adult patients with chronic open wounds were randomly selected for study. The patients were randomly divided into the hypochlorous acid irrigation or saline irrigation group. All patients provided pre- and postoperative tissue samples for qualitative and quantitative bacteriology. For the time (7 days) between the debridement procedure and the definitive closure procedure, the wounds were dressed with a silver-impregnated dressing and a hydroconductive dressing. Results : Both types of irrigation in the ultrasonic system initially lowered the bacterial counts by 4 to 6 logs. However, by the time of definitive closure, the saline-irrigated wounds had bacterial counts back up to 10 5 whereas the hypochlorous acid-irrigated wounds remained at 10 2 or fewer. More than 80% of patients in the saline group had postoperative closure failure compared with 25% of patients in the hypochlorous acid group. Conclusions: Hypochlorous acid irrigation with ultrasound debridement reduced bacterial growth in chronic open wounds more efficiently than saline alone. Postoperative wound closure outcomes suggest a remarkable reduction in wound complications after wound debridement using hypochlorous acid irrigation with ultrasound versus saline alone.

Explicit knowledge about the availability of visual feedback affects grasping with the left but not the right hand.

PubMed

Tang, Rixin; Whitwell, Robert L; Goodale, Melvyn A

2014-01-01

Previous research (Whitwell et al. in Exp Brain Res 188:603-611, 2008; Whitwell and Goodale in Exp Brain Res 194:619-629, 2009) has shown that trial history, but not anticipatory knowledge about the presence or absence of visual feedback on an upcoming trial, plays a vital role in determining how that feedback is exploited when grasping with the right hand. Nothing is known about how the non-dominant left hand behaves under the same feedback regimens. In present study, therefore, we compared peak grip aperture (PGA) for left- and right-hand grasps executed with and without visual feedback (i.e., closed- vs. open-loop conditions) in right-handed individuals under three different trial schedules: the feedback conditions were blocked separately, they were randomly interleaved, or they were alternated. When feedback conditions were blocked, the PGA was much larger for open-loop trials as compared to closed-loop trials, although this difference was more pronounced for right-hand grasps than left-hand grasps. Like Whitwell et al., we found that mixing open- and closed-loop trials together, compared to blocking them separately, homogenized the PGA for open- and closed-loop grasping in the right hand (i.e., the PGAs became smaller on open-loop trials and larger on closed-loop trials). In addition, the PGAs for right-hand grasps were entirely determined by trial history and not by knowledge of whether or not visual feedback would be available on an upcoming trial. In contrast to grasps made with the right hand, grasps made by the left hand were affected both by trial history and by anticipatory knowledge of the upcoming visual feedback condition. But these effects were observed only on closed-loop trials, i.e., the PGAs of grasps made with the left hand on closed-loop trials were smaller when participants could anticipate the availability of feedback on an upcoming trial (alternating trials) than when they could not (randomized trials). In contrast, grasps made with the left hand on open-loop trials exhibited the same large PGAs under all feedback schedules: blocked, random, or alternating. In other words, there was no evidence for homogenization. Taken together, these results suggest that in addition to the real-time demands of the task, such as the target's size and position and the availability of visual feedback, the initial (i.e., pre-movement) programming of right-hand grasping relies on what happened on the previous trial, whereas the programming of left-hand grasping is more cognitively supervised and exploits explicit information about trial order to prepare for an upcoming trial.

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

PubMed

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

2010-03-01

The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 +/- 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, although these differences were not significant. However, diarrhea had resolved in significantly more children on day 3 in the S. boulardii group (48.5% versus 25.5%; P < 0.05). In outpatient cases, yogurt treatment was cheaper than S. boulardii whereas in hospitalized patients, treatment cost was similar. In conclusion, the effect of daily freshly prepared YF was comparable to S. boulardii in the treatment of acute non-bloody diarrhea in children. The duration of diarrhea was shorter in the S. boulardii group, expressed as a significantly higher number of patients with normal stools on day 3.

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

PubMed Central

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

2010-01-01

The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 ± 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, although these differences were not significant. However, diarrhea had resolved in significantly more children on day 3 in the S. boulardii group (48.5% versus 25.5%; P < 0.05). In outpatient cases, yogurt treatment was cheaper than S. boulardii whereas in hospitalized patients, treatment cost was similar. In conclusion, the effect of daily freshly prepared YF was comparable to S. boulardii in the treatment of acute non-bloody diarrhea in children. The duration of diarrhea was shorter in the S. boulardii group, expressed as a significantly higher number of patients with normal stools on day 3. PMID:20207879

The cost effectiveness of elective laparoscopic sigmoid resection for symptomatic diverticular disease: financial outcome of the randomized control Sigma trial.

PubMed

Klarenbeek, Bastiaan R; Coupé, Veerle M H; van der Peet, Donald L; Cuesta, Miguel A

2011-03-01

Direct healthcare costs of patients with symptomatic diverticular disease randomized for either laparoscopic or open elective sigmoid resection are compared. Cost-effectiveness analysis of the laparoscopic approach compared with open sigmoid resections is presented. An economic evaluation of the randomized control Sigma trial was conducted, comparing elective laparoscopic sigmoid resection (LSR) to open sigmoid resection (OSR) in patients with symptomatic diverticulitis. Prospective registration of detailed intervention units per patient resulted in actual resource use per individual patient. To avoid distributional assumptions, the nonparametric bootstrap was applied. For the cost-effectiveness analysis, differences in total cost between LSR and OSR were compared with the differences in VAS pain score, SF-36 values for general health, and complication rate. The difference in total healthcare costs between the group that received LSR (euro 9969) and the group that received OSR (euro 9366) was not statistically significant. The slight increase in total costs was determined mainly by the significantly higher operation costs of LSR (euro 6663 vs. euro 5306). Lower costs for hospitalization (euro 2983 vs. euro 3598), blood products (euro 87 vs. euro 240), paramedical services (euro 157 vs. euro 278), and emergency attendance (euro 72 vs. euro 115) in the LSR group partially compensated these increased operation costs. The incremental cost-effectiveness ratios (ICER) indicate that improvements in pain, quality of life, and complication rate could be achieved at limited costs. Total healthcare costs of laparoscopic and open elective sigmoid resections for symptomatic diverticular disease are similar. As the clinical outcomes are in favor of the LSR group, candidates for an elective sigmoid resection should preferably be approached laparoscopically.

The effect of screening doors and windows on indoor density of Anopheles arabiensis in south-west Ethiopia: a randomized trial

PubMed Central

2013-01-01

Background Screening of houses might have impact on density of indoor host-seeking Anopheles mosquitoes. A randomized trial of screening windows and doors with metal mesh, and closing openings on eves and walls by mud was conducted to assess if reduce indoor densities of biting mosquitoes. Methods Mosquitoes were collected in forty houses using Centers for Diseases Control and Prevention (CDC) light traps biweekly in March and April 2011. A randomization of houses into control and intervention groups was done based on the baseline data. Windows and doors of 20 houses were screened by metal mesh, and openings on the walls and eves closed by mud and the rest 20 houses were used as control group. Mosquitoes were collected biweekly in October and November 2011 from both control and intervention houses. A Generalized Estimating Equations (GEE) with a negative binomial error distribution was used to account for over dispersion of Anopheles arabiensis and culicine counts and repeated catches made in the same house. Results Screening doors and windows, and closing openings on eves and wall by mud reduced the overall indoor densities of An. arabiensis by 40%. The effect of screenings pronounced on unfed An. arabiensis by resulting 42% reduction in houses with interventions. The total costs for screening windows and doors, and to close openings on the eves and walls by mud was 7.34 USD per house. Conclusion Screening houses reduced indoor density of An. arabiensis, and it was cheap and can easily incorporated into malaria vector strategies by local communities, but improving doors and windows fitness for screening should be considered during house construction to increase the efficacy of screenings. PMID:24028542

The effect of screening doors and windows on indoor density of Anopheles arabiensis in south-west Ethiopia: a randomized trial.

PubMed

Massebo, Fekadu; Lindtjørn, Bernt

2013-09-12

Screening of houses might have impact on density of indoor host-seeking Anopheles mosquitoes. A randomized trial of screening windows and doors with metal mesh, and closing openings on eves and walls by mud was conducted to assess if reduce indoor densities of biting mosquitoes. Mosquitoes were collected in forty houses using Centers for Diseases Control and Prevention (CDC) light traps biweekly in March and April 2011. A randomization of houses into control and intervention groups was done based on the baseline data. Windows and doors of 20 houses were screened by metal mesh, and openings on the walls and eves closed by mud and the rest 20 houses were used as control group. Mosquitoes were collected biweekly in October and November 2011 from both control and intervention houses. A Generalized Estimating Equations (GEE) with a negative binomial error distribution was used to account for over dispersion of Anopheles arabiensis and culicine counts and repeated catches made in the same house. Screening doors and windows, and closing openings on eves and wall by mud reduced the overall indoor densities of An. arabiensis by 40%. The effect of screenings pronounced on unfed An. arabiensis by resulting 42% reduction in houses with interventions. The total costs for screening windows and doors, and to close openings on the eves and walls by mud was 7.34 USD per house. Screening houses reduced indoor density of An. arabiensis, and it was cheap and can easily incorporated into malaria vector strategies by local communities, but improving doors and windows fitness for screening should be considered during house construction to increase the efficacy of screenings.

Laparoscopic versus open resection for transverse and descending colon cancer: Short-term and long-term outcomes of a multicenter retrospective study of 1830 patients.

PubMed

Yamaguchi, Shigeki; Tashiro, Jo; Araki, Ryuichiro; Okuda, Junji; Hanai, Tsunekazu; Otsuka, Koki; Saito, Shuji; Watanabe, Masahiko; Sugihara, Kenichi

2017-08-01

Previous randomized controlled trials demonstrated similar oncological outcomes between laparoscopic and open colectomies, except for cases involving transverse colon and splenic flexure colon cancer. The objective of this study was to confirm the oncological safety and advantages of the short-term results of laparoscopic surgery for transverse and descending colon cancer in comparison with open surgery. The study data were retrospectively collected from the databases of 45 hospitals. Patients with transverse or descending colon cancer who underwent laparoscopic or open R0 resection were registered. The primary end-points were the 3-year overall survival and relapse-free survival rates according to pathological stage. The secondary end-points were the short-term results, including blood loss, operative time, diet intake, hospital stay, and postoperative complications. Of the 1830 eligible patients, 872 underwent open colectomy and 958 underwent laparoscopic colectomy. The median follow-up period was 38.4 months. The conversion rate to open resection was 4.5%. The 3-year overall survival rate of the laparoscopic group was significantly higher than that of the open group for stage I patients (96.2% vs 99.2%; P = 0.04); it was also higher for stage II (94.0% vs 95.5%) and stage III (87.4% vs 90.2%) patients, but there were no significant differences. The 3-year relapse-free survival rate of the laparoscopic group was significantly higher than that of the open group for stage I patients; there were no differences between the open and laparoscopic groups among the stage II and III patients. In the multivariate analyses, laparoscopic resection was a significant factor in relapse-free survival. Laparoscopic patients had significantly lower blood loss and a significantly longer operative time than the open groups. Also, postoperative hospital stay was significantly shorter and postoperative morbidity was significantly lower in the laparoscopic group. Although this retrospective study has limitations, we can conclude that laparoscopic surgery for transverse and descending colon cancer is oncologically safe and yields better short-term results than open surgery. © 2017 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.

Effect of the cognitive-motor dual-task using auditory cue on balance of surviviors with chronic stroke: a pilot study.

PubMed

Choi, Wonjae; Lee, GyuChang; Lee, Seungwon

2015-08-01

To investigate the effect of a cognitive-motor dual-task using auditory cues on the balance of patients with chronic stroke. Randomized controlled trial. Inpatient rehabilitation center. Thirty-seven individuals with chronic stroke. The participants were randomly allocated to the dual-task group (n=19) and the single-task group (n=18). The dual-task group performed a cognitive-motor dual-task in which they carried a circular ring from side to side according to a random auditory cue during treadmill walking. The single-task group walked on a treadmill only. All subjects completed 15 min per session, three times per week, for four weeks with conventional rehabilitation five times per week over the four weeks. Before and after intervention, both static and dynamic balance were measured with a force platform and using the Timed Up and Go (TUG) test. The dual-task group showed significant improvement in all variables compared to the single-task group, except for anteroposterior (AP) sway velocity with eyes open and TUG at follow-up: mediolateral (ML) sway velocity with eye open (dual-task group vs. single-task group: 2.11 mm/s vs. 0.38 mm/s), ML sway velocity with eye close (2.91 mm/s vs. 1.35 mm/s), AP sway velocity with eye close (4.84 mm/s vs. 3.12 mm/s). After intervention, all variables showed significant improvement in the dual-task group compared to baseline. The study results suggest that the performance of a cognitive-motor dual-task using auditory cues may influence balance improvements in chronic stroke patients. © The Author(s) 2014.

Vaccination response to tetanus toxoid and 23-valent pneumococcal vaccines following administration of a single dose of abatacept: a randomized, open-label, parallel group study in healthy subjects

PubMed Central

Tay, Lee; Leon, Francisco; Vratsanos, George; Raymond, Ralph; Corbo, Michael

2007-01-01

The effect of abatacept, a selective T-cell co-stimulation modulator, on vaccination has not been previously investigated. In this open-label, single-dose, randomized, parallel-group, controlled study, the effect of a single 750 mg infusion of abatacept on the antibody response to the intramuscular tetanus toxoid vaccine (primarily a memory response to a T-cell-dependent peptide antigen) and the intramuscular 23-valent pneumococcal vaccine (a less T-cell-dependent response to a polysaccharide antigen) was measured in 80 normal healthy volunteers. Subjects were uniformly randomized to receive one of four treatments: Group A (control group), subjects received vaccines on day 1 only; Group B, subjects received vaccines 2 weeks before abatacept; Group C, subjects received vaccines 2 weeks after abatacept; and Group D, subjects received vaccines 8 weeks after abatacept. Anti-tetanus and anti-pneumococcal (Danish serotypes 2, 6B, 8, 9V, 14, 19F and 23F) antibody titers were measured 14 and 28 days after vaccination. While there were no statistically significant differences between the dosing groups, geometric mean titers following tetanus or pneumococcal vaccination were generally lower in subjects who were vaccinated 2 weeks after receiving abatacept, compared with control subjects. A positive response (defined as a twofold increase in antibody titer from baseline) to tetanus vaccination at 28 days was seen, however, in ≥ 60% of subjects across all treatment groups versus 75% of control subjects. Similarly, over 70% of abatacept-treated subjects versus all control subjects (100%) responded to at least three pneumococcal serotypes, and approximately 25–30% of abatacept-treated subjects versus 45% of control subjects responded to at least six serotypes. PMID:17425783

Estimating temporary emigration and breeding proportions using capture-recapture data with Pollock's robust design

USGS Publications Warehouse

Kendall, W.L.; Nichols, J.D.; Hines, J.E.

1997-01-01

Statistical inference for capture-recapture studies of open animal populations typically relies on the assumption that all emigration from the studied population is permanent. However, there are many instances in which this assumption is unlikely to be met. We define two general models for the process of temporary emigration, completely random and Markovian. We then consider effects of these two types of temporary emigration on Jolly-Seber (Seber 1982) estimators and on estimators arising from the full-likelihood approach of Kendall et al. (1995) to robust design data. Capture-recapture data arising from Pollock's (1982) robust design provide the basis for obtaining unbiased estimates of demographic parameters in the presence of temporary emigration and for estimating the probability of temporary emigration. We present a likelihood-based approach to dealing with temporary emigration that permits estimation under different models of temporary emigration and yields tests for completely random and Markovian emigration. In addition, we use the relationship between capture probability estimates based on closed and open models under completely random temporary emigration to derive three ad hoc estimators for the probability of temporary emigration, two of which should be especially useful in situations where capture probabilities are heterogeneous among individual animals. Ad hoc and full-likelihood estimators are illustrated for small mammal capture-recapture data sets. We believe that these models and estimators will be useful for testing hypotheses about the process of temporary emigration, for estimating demographic parameters in the presence of temporary emigration, and for estimating probabilities of temporary emigration. These latter estimates are frequently of ecological interest as indicators of animal movement and, in some sampling situations, as direct estimates of breeding probabilities and proportions.

A randomized, multicenter, open-label study of poly-L-lactic acid for HIV-1 facial lipoatrophy.

PubMed

Carey, Dianne L; Baker, David; Rogers, Gary D; Petoumenos, Kathy; Chuah, John; Easey, Nicole; Machon, Kirsty; Cooper, David A; Emery, Sean; Carr, Andrew

2007-12-15

Facial lipoatrophy can stigmatize and can reduce quality of life, self esteem, and antiretroviral adherence. Poly-L-lactic acid (PLA) injections seem safe and effective, but no randomized study has included objective endpoints. HIV-positive adults with moderate/severe facial lipoatrophy were randomized to 4 open-label PLA treatments administered every 2 weeks from week 0 (immediate group, n = 51) or after week 24 (deferred group, n = 50). The primary endpoint was mean change in facial soft tissue volume (FSTV), as assessed by spiral computed tomography. Analyses were by intention to treat. At week 24, mean changes in FSTV were 0 cm3 in the intermediate group and -10 cm3 in the deferred group (between-group difference of 10 [95% confidence interval (CI): -7 to 28] cm3; P = 0.24). The immediate group had a greater mean change in soft tissue depth at the maxilla (2.2 mm [95% CI: 1.6 to 2.9]; P < 0.0001) and base of the nasal septum (1.0 mm [95% CI: 0.3 to 1.6]; P = 0.003) levels. PLA did not have an impact on peripheral fat mass, viral load, or antiretroviral adherence. Patient and physician subjectively assessed facial lipoatrophy severity (P < 0.0001), 2 of 8 Short Form-36 Health Survey and 2 of 5 Multidimensional Body-Self Relations Questionnaire-Appearance Scales, scores improved significantly. The median duration of treatment-related adverse events was 2 (interquartile range: 1 to 3) days. PLA did not increase FSTV, although tissue thickness in injection planes increased modestly, an improvement observed by patients. PLA was safe and well tolerated. Facial lipoatrophy severity and some quality-of-life domains improved.

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

PubMed

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

2016-12-01

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

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial.

PubMed

Borius, Pierre-Yves; Garnier, Stéphanie Ranque; Baumstarck, Karine; Castinetti, Frédéric; Donnet, Anne; Guedj, Eric; Cornu, Philippe; Blond, Serge; Salas, Sébastien; Régis, Jean

2017-08-02

Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life. Copyright © 2017 by the Congress of Neurological Surgeons

Bioavailability of everolimus administered as a single 5 mg tablet versus five 1 mg tablets: a randomized, open-label, two-way crossover study of healthy volunteers.

PubMed

Thudium, Karen; Gallo, Jorge; Bouillaud, Emmanuel; Sachs, Carolin; Eddy, Simantini; Cheung, Wing

2015-01-01

The mammalian target of rapamycin (mTOR) inhibitor everolimus has a well-established pharmacokinetics profile. We conducted a randomized, single-center, open-label, two-sequence, two-period crossover study of healthy volunteers to assess the relative bioavailability of everolimus administered as one 5 mg tablet or five 1 mg tablets. Subjects were randomized 1:1 to receive everolimus dosed as one 5 mg tablet or as five 1 mg tablets on day 1, followed by a washout period on days 8-14 and then the opposite formulation on day 15. Blood sampling for pharmacokinetic evaluation was performed at prespecified time points, with 17 samples taken for each treatment period. Primary variables for evaluation of relative bioavailability were area under the concentration-time curve from time zero to infinity (AUCinf) and maximum blood concentration (Cmax). Safety was assessed by reporting the incidence of adverse events (AEs). Twenty-two participants received everolimus as one 5 mg tablet followed by five 1 mg tablets (n=11) or the opposite sequence (n=11). The Cmax of five 1 mg tablets was 48% higher than that of one 5 mg tablet (geometric mean ratio, 1.48; 90% confidence interval [CI], 1.35-1.62). AUCinf was similar (geometric mean ratio, 1.08; 90% CI, 1.02-1.16), as were the extent of absorption and the distribution and elimination kinetics. AEs, all grade 1 or 2, were observed in 54.5% of subjects. Although the extent of absorption was similar, the Cmax of five 1 mg tablets was higher than that of one 5 mg tablet, suggesting these formulations lead to different peak blood concentrations and are not interchangeable at the dose tested.

An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age.

PubMed

Kosalaraksa, Pope; Mehlsen, Jesper; Vesikari, Timo; Forstén, Aino; Helm, Klaus; Van Damme, Pierre; Joura, Elmar A; Ciprero, Karen; Maansson, Roger; Luxembourg, Alain; Sobanjo-ter Meulen, Ajoke

2015-06-01

A 9-valent human papillomavirus (9vHPV) vaccine has recently been reported to be safe and highly efficacious against infection and disease related to HPV6/11/16/18/31/33/45/52/58. We evaluated the immunogenicity and safety of the 9vHPV vaccine administered concomitantly with REPEVAX (diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis vaccine). This open-label, randomized, multicenter study enrolled 1054 males and females ages 11-15 years. Subjects were randomly assigned to each group in a 1:1 ratio. Subjects received a 0.5 mL dose of 9vHPV vaccine intramuscularly at day 1, months 2 and 6 and a 0.5 mL dose of REPEVAX either on day 1 (concomitant vaccination group; n = 526) or at month 1 (nonconcomitant vaccination group, n = 528). Serologic responses for each vaccine component were tested by 1-sided tests of noninferiority between groups. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored. Noninferiority of anti-HPV geometric mean titers and seroconversion rates for all 9vHPV antigens were demonstrated for the concomitant group compared with the nonconcomitant group. Seroconversion rates for the 9vHPV vaccine types were ≥99.8% in both groups at month 7. For REPEVAX, noninferiority of immune response was established for diphtheria, tetanus, all polio and pertussis antigens for both groups. There were no vaccine-related serious AEs. Overall, concomitant administration of 9vHPV vaccine and REPEVAX was generally well tolerated and did not interfere with the immune response to either vaccine. This strategy would minimize the number of visits required to deliver each vaccine individually.

Effects of parecoxib on analgesia benefit and blood loss following open prostatectomy: a multicentre randomized trial.

PubMed

Dirkmann, Daniel; Groeben, Harald; Farhan, Hassan; Stahl, David L; Eikermann, Matthias

2015-01-01

This multi-centre, prospective, randomized, double-blind, placebo-controlled study was designed to test the hypotheses that parecoxib improves patients' postoperative analgesia without increasing surgical blood loss following radical open prostatectomy. 105 patients (64 ± 7 years old) were randomized to receive either parecoxib or placebo with concurrent morphine patient controlled analgesia. Cumulative opioid consumption (primary objective) and the overall benefit of analgesia score (OBAS), the modified brief pain inventory short form (m-BPI-sf), the opioid-related symptom distress scale (OR-SDS), and perioperative blood loss (secondary objectives) were assessed. In each group 48 patients received the study medication for 48 hours postoperatively. Parecoxib significantly reduced cumulative opioid consumption by 24% (43 ± 24.1 mg versus 57 ± 28 mg, mean ± SD, p=0.02), translating into improved benefit of analgesia (OBAS: 2(0/4) versus 3(1/5.25), p=0.01), pain severity (m-BPI-sf: 1(1/2) versus 2(2/3), p < 0.01) and pain interference (m-BPI-sf: 1(0/1) versus 1(1/3), p=0.001), as well as reduced opioid-related side effects (OR-SDS score: 0.3(0.075/0.51) versus 0.4(0.2/0.83), p=0.03). Blood loss was significantly higher at 24 hours following surgery in the parecoxib group (4.3 g⋅dL(-1) (3.6/4.9) versus (3.2 g⋅dL(-1) (2.4/4.95), p=0.02). Following major abdominal surgery, parecoxib significantly improves patients' perceived analgesia. Parecoxib may however increase perioperative blood loss. Further trials are needed to evaluate the effects of selective cyclooxygenase-2 inhibitors on blood loss. ClinicalTrials.gov Identifier: NCT00346268.

Psychosocial outcomes after initial treatment of erectile dysfunction with tadalafil once daily, tadalafil on demand or sildenafil citrate on demand: results from a randomized, open-label study.

PubMed

Hatzimouratidis, K; Buvat, J; Büttner, H; Vendeira, P A S; Moncada, I; Boehmer, M; Henneges, C; Boess, F G

2014-01-01

Initiation of ED treatment with a particular PDE5I may influence treatment-adherence and other outcomes. In this multicenter, open-label study, men with ED, naïve to PDE5I, were randomized to tadalafil 5 mg once-a-day (OaD; N=257), 10 mg on demand (PRN; N = 252) or sildenafil-citrate (sildenafil) 50 mg PRN (N = 261) for 8 weeks (dose adjustments allowed), followed by 16 weeks of pragmatic treatment (switching between PDE5I allowed). Primary outcomes (treatment-adherence) were reported previously. Here, we report effects on: Psychological and Interpersonal Relationship Scales, Self-Esteem and Relationship (SEAR) questionnaire, ED Inventory of Treatment Satisfaction (EDITS), International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) and Global Assessment Questions (GAQ). Mixed-model for repeated measures and analysis of covariance were used to analyze changes from baseline; GAQ-responses were evaluated by logistic regression. Analyses were adjusted for treatment, country, ED-severity, baseline and baseline-by-treatment interaction. Patients randomized to tadalafil OaD or PRN reported greater improvement (least-square mean (s.e.) change) in Sexual Self-Confidence (OaD +0.90 (0.048), PRN +0.93 (0.050), vs +0.73 (0.049); P=0.006 and P=0.001) and Spontaneity (OaD +0.11 (0.035), PRN +0.13 (0.035), vs +0.02 (0.035); P = 0.044 and P = 0.010) compared with sildenafil. Improvements in GAQ and SEP responses, IIEF-EF, orgasmic function, sexual desire, overall satisfaction domains, SEAR and EDITS scores did not differ significantly between treatment groups.

The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial.

PubMed

Chu, Edward W; Chernoguz, Artur; Divino, Celia M

2016-06-01

The perioperative safety profile of clopidogrel, a potent antiplatelet agent used in the management of cardiovascular disease, is unknown, and there are no evidence-based guidelines recommending for either its interruption or continuation at this time. The aim of this study was to determine whether patients who are maintained on clopidogrel before general surgical procedures are at increased risk of perioperative bleeding complications. Patients receiving clopidogrel at the time of elective general surgery were randomized to either discontinue clopidogrel 1 week before surgery (group A) or continue clopidogrel into surgery (group B). All other antiplatelet and anticoagulant agents were discontinued before surgery. The primary end points were perioperative bleeding requiring intraoperative or postoperative transfusion of blood or blood components and bleeding-related readmission, reoperation, or mortality within 90 days of surgery. The secondary end points were perioperative myocardial infarction or cerebrovascular accidents within 90 days of surgery. Thirty-nine patients were enrolled and underwent 43 general surgical operations. Twenty-one procedures were randomized to group A and 22 to group B. The most commonly performed individual procedures were open inguinal hernia repair (23%), laparoscopic cholecystectomy (21%), open ventral hernia repair (15%), laparoscopic ventral hernia repair (11%), and laparoscopic inguinal hernia repair (9%). No perioperative mortalities, bleeding events requiring blood transfusion, or reoperations occurred. One readmission for intra-abdominal hematoma requiring percutaneous drainage occurred in each group (group A: 4.8% vs group B: 4.5%; P = 1.0). No myocardial infarctions or cerebrovascular accidents were observed or reported. The outcomes from this prospective study suggest that, patients undergoing commonly performed elective general surgical procedures can be safely maintained on clopidogrel without increased perioperative bleeding risk. Copyright © 2016 Elsevier Inc. All rights reserved.

Patient-controlled methylphenidate for cancer fatigue: a double-blind, randomized, placebo-controlled trial.

PubMed

Bruera, Eduardo; Valero, Vicente; Driver, Larry; Shen, Loren; Willey, Jie; Zhang, Tao; Palmer, J Lynn

2006-05-01

To evaluate the effectiveness of patient-controlled methylphenidate as compared with placebo in cancer patients with fatigue, as measured by the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F). Patients with a fatigue score of at least 4 on a scale of 0 to 10 (0 = no fatigue, 10 = worst possible fatigue) and hemoglobin level of at least 10 g/dL were included. Patients were randomly assigned to receive 5 mg methylphenidate or placebo every 2 hours as needed (maximum of four capsules a day), for 7 days. Patients completed a daily diary including study drug record and fatigue intensity. A research nurse telephoned patients daily to assess toxicity and fatigue level. All patients were offered open-label methylphenidate for 4 weeks. FACIT-F and the Edmonton Symptom Assessment System (ESAS) were assessed at baseline, and days 8, 15, and 36. The FACIT-F fatigue subscore on day 8 was considered the primary end point. Of 112 patients randomly assigned, 52 patients in the methylphenidate and 53 in the placebo group were assessable for analysis. Fatigue intensity improved significantly on day 8 in both the methylphenidate and placebo groups. However, there was no significant difference in fatigue improvement by FACIT-F (P = .31) or ESAS (P = .14) between groups. In open-label phase, fatigue intensity maintained low as compared with baseline. No significant toxicities were observed. Both methylphenidate and placebo resulted in significant symptom improvement. Methylphenidate was not significantly superior to placebo after 1 week of treatment. Longer study duration is justified. The role of daily telephone calls from a research nurse should be explored as a palliative care intervention.

Green tea (Camellia sinensis) for patients with knee osteoarthritis: A randomized open-label active-controlled clinical trial.

PubMed

Hashempur, Mohammad Hashem; Sadrneshin, Sara; Mosavat, Seyed Hamdollah; Ashraf, Alireza

2018-02-01

Green tea is known as a dietary supplement and a novel functional food worldwide. Since there are increasing preclinical evidence about efficacy of green tea for treating osteoarthritis, this study has aimed at assessing its efficacy and safety for patients with knee osteoarthritis. This is a randomized open-label active-controlled clinical trial. As many as fifty adults with osteoarthritis of knee were randomly allocated to receive the green tea extract (in dosage form of tablet) plus diclofenac tablet as "intervention group"; or: diclofenac tablet alone as "control group" for a period of four weeks. Patients were assessed at the beginning of intervention, and then 4 weeks later, in terms of pain score via visual analogue scale (VAS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire's total score in addition to its 3 sub-scores. Furthermore, they were asked about any adverse effects during intervention period. Mean differences of VAS pain, total WOMAC, and WOMAC physical function scores in green tea group showed a significant reduction, compared with the control group (P = 0.038, P = 0.006, and P = 0.004, respectively). However, No significant differences between the two groups were observed, regarding mean differences of WOMAC pain and stiffness scores of the enrolled patients (P = 0.163, and P = 0.150, respectively). Additionally, only 1 patient reported gastric upset [in control group]. It seems that green tea extract might well be considered as an adjunctive treatment both for control of pain and for the betterment of knee joint physical function in adults with osteoarthritis. However, further studies of longer duration and larger sample size are needed. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants.

PubMed

Abdelnour, Arturo; Silas, Peter E; Lamas, Marta Raquel Valdés; Aragón, Carlos Fernándo Grazioso; Chiu, Nan-Chang; Chiu, Cheng-Hsun; Acuña, Teobaldo Herrera; Castrejón, Tirza De León; Izu, Allen; Odrljin, Tatjana; Smolenov, Igor; Hohenboken, Matthew; Dull, Peter M

2014-02-12

The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants. Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%). A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups. In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone. Copyright © 2013 Elsevier Ltd. All rights reserved.

Subject-driven titration of biphasic insulin aspart 30 twice daily is non-inferior to investigator-driven titration in Chinese patients with type 2 diabetes inadequately controlled with premixed human insulin: A randomized, open-label, parallel-group, multicenter trial.

PubMed

Yang, Wenying; Zhu, Lvyun; Meng, Bangzhu; Liu, Yu; Wang, Wenhui; Ye, Shandong; Sun, Li; Miao, Heng; Guo, Lian; Wang, Zhanjian; Lv, Xiaofeng; Li, Quanmin; Ji, Qiuhe; Zhao, Weigang; Yang, Gangyi

2016-01-01

The present study was to compare the efficacy and safety of subject-driven and investigator-driven titration of biphasic insulin aspart 30 (BIAsp 30) twice daily (BID). In this 20-week, randomized, open-label, two-group parallel, multicenter trial, Chinese patients with type 2 diabetes inadequately controlled by premixed/self-mixed human insulin were randomized 1:1 to subject-driven or investigator-driven titration of BIAsp 30 BID, in combination with metformin and/or α-glucosidase inhibitors. Dose adjustment was decided by patients in the subject-driven group after training, and by investigators in the investigator-driven group. Eligible adults (n = 344) were randomized in the study. The estimated glycated hemoglobin (HbA1c) reduction was 14.5 mmol/mol (1.33%) in the subject-driven group and 14.3 mmol/mol (1.31%) in the investigator-driven group. Non-inferiority of subject-titration vs investigator-titration in reducing HbA1c was confirmed, with estimated treatment difference -0.26 mmol/mol (95% confidence interval -2.05, 1.53) (-0.02%, 95% confidence interval -0.19, 0.14). Fasting plasma glucose, postprandial glucose increment and self-measured plasma glucose were improved in both groups without statistically significant differences. One severe hypoglycemic event was experienced by one subject in each group. A similar rate of nocturnal hypoglycemia (events/patient-year) was reported in the subject-driven (1.10) and investigator-driven (1.32) groups. There were 64.5 and 58.1% patients achieving HbA1c <53.0 mmol/mol (7.0%), and 51.2 and 45.9% patients achieving the HbA1c target without confirmed hypoglycemia throughout the trial in the subject-driven and investigator-driven groups, respectively. Subject-titration of BIAsp 30 BID was as efficacious and well-tolerated as investigator-titration. The present study supported patients to self-titrate BIAsp 30 BID under physicians' supervision.

Rationale, study design, and implementation of the ACS1 study: effect of azilsartan on circadian and sleep blood pressure as compared with amlodipine.

PubMed

Kario, Kazuomi; Hoshide, Satoshi

2014-06-01

The ACS1 (Azilsartan Circadian and Sleep Pressure - the first study) is a multicenter, randomized, open-label, two parallel-group study carried out to investigate the efficacy of an 8-week oral treatment with azilsartan 20 mg in comparison with amlodipine 5 mg. The patients with stage I or II primary hypertension will be randomly assigned to either an azilsartan group (n=350) or an amlodipine group (n=350). The primary endpoint is a change in nocturnal systolic blood pressure (BP) as measured by ambulatory BP monitoring at the end of follow-up relative to the baseline level during the run-in period. In addition, we will carry out the same analysis after dividing four different nocturnal BP dipping statuses (extreme-dippers, dippers, nondipper, and risers). The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm.

Rationale, study design, and implementation of the ACS1 study: effect of azilsartan on circadian and sleep blood pressure as compared with amlodipine

PubMed Central

Hoshide, Satoshi

2014-01-01

Objective The ACS1 (Azilsartan Circadian and Sleep Pressure – the first study) is a multicenter, randomized, open-label, two parallel-group study carried out to investigate the efficacy of an 8-week oral treatment with azilsartan 20 mg in comparison with amlodipine 5 mg. Materials and methods The patients with stage I or II primary hypertension will be randomly assigned to either an azilsartan group (n=350) or an amlodipine group (n=350). The primary endpoint is a change in nocturnal systolic blood pressure (BP) as measured by ambulatory BP monitoring at the end of follow-up relative to the baseline level during the run-in period. In addition, we will carry out the same analysis after dividing four different nocturnal BP dipping statuses (extreme-dippers, dippers, nondipper, and risers). Conclusion The findings of this study will help in establishing an appropriate antihypertensive treatment for hypertensive patients with a disrupted circadian BP rhythm. PMID:24637789

The effect of food on the pharmacokinetics of oral ibrutinib in healthy participants and patients with chronic lymphocytic leukemia.

PubMed

de Jong, Jan; Sukbuntherng, Juthamas; Skee, Donna; Murphy, Joe; O'Brien, Susan; Byrd, John C; James, Danelle; Hellemans, Peter; Loury, David J; Jiao, Juhui; Chauhan, Vijay; Mannaert, Erik

2015-05-01

To assess ibrutinib pharmacokinetics under fasted and fed conditions, impact of food-intake timing, and the safety and tolerability. Three studies were analyzed. Study 1 was a randomized, open-label, single-dose, four-way crossover study in 44 healthy participants. Study 2 was a randomized, repeat-dose crossover study in 16 patients with previously treated chronic lymphocytic leukemia (CLL). Ibrutinib dose was 420 mg in both studies. Study 3 was an open-label, sequential study to assess the effect of a standard breakfast on ibrutinib 560 mg in eight healthy participants. Administration of single-dose ibrutinib under fasting conditions (study 1) resulted in approximately 60 % of exposure compared with drug intake either 30 min before, 30 min after (fed), or 2 h after a high-fat meal. Similar food effect was observed (study 3) when ibrutinib was given 30 min before meal. In CLL patients (study 2), the C max and AUC under fasting conditions were 43 and 61 %, respectively, relative to fed conditions. When administered once-daily in uncontrolled food-intake conditions (≥30 min before or 2 h after), exposures were slightly (≈30 %) lower than in fed condition. When corrected for repeated dosing, pharmacokinetic parameters in healthy participants and patients were comparable. Ibrutinib was generally well tolerated in all settings studied. Ibrutinib administered in fasted condition reduces exposure to approximately 60 % as compared with dosing in proximity to food-intake, regardless of timing/type of meal. Because repeated drug intake in fasted condition is unlikely, no food restrictions may be needed to administer ibrutinib.

Comparison of the Efficacy and Safety of Aripiprazole Versus Bupropion Augmentation in Patients With Major Depressive Disorder Unresponsive to Selective Serotonin Reuptake Inhibitors: A Randomized, Prospective, Open-Label Study.

PubMed

Cheon, Eun-Jin; Lee, Kwang-Hun; Park, Young-Woo; Lee, Jong-Hun; Koo, Bon-Hoon; Lee, Seung-Jae; Sung, Hyung-Mo

2017-04-01

The purpose of this study was to compare the efficacy and safety of aripiprazole versus bupropion augmentation in patients with major depressive disorder (MDD) unresponsive to selective serotonin reuptake inhibitors (SSRIs). This is the first randomized, prospective, open-label, direct comparison study between aripiprazole and bupropion augmentation. Participants had at least moderately severe depressive symptoms after 4 weeks or more of SSRI treatment. A total of 103 patients were randomized to either aripiprazole (n = 56) or bupropion (n = 47) augmentation for 6 weeks. Concomitant use of psychotropic agents was prohibited. Montgomery Asberg Depression Rating Scale, 17-item Hamilton Depression Rating scale, Iowa Fatigue Scale, Drug-Induced Extrapyramidal Symptoms Scale, Psychotropic-Related Sexual Dysfunction Questionnaire scores were obtained at baseline and after 1, 2, 4, and 6 weeks of treatment. Overall, both treatments significantly improved depressive symptoms without causing serious adverse events. There were no significant differences in the Montgomery Asberg Depression Rating Scale, 17-item Hamilton Depression Rating scale, and Iowa Fatigue Scale scores, and response rates. However, significant differences in remission rates between the 2 groups were evident at week 6 (55.4% vs 34.0%, respectively; P = 0.031), favoring aripiprazole over bupropion. There were no significant differences in adverse sexual events, extrapyramidal symptoms, or akathisia between the 2 groups. The present study suggests that aripiprazole augmentation is at least comparable to bupropion augmentation in combination with SSRI in terms of efficacy and tolerability in patients with MDD. Both aripiprazole and bupropion could help reduce sexual dysfunction and fatigue in patients with MDD. Aripiprazole and bupropion may offer effective and safe augmentation strategies in patients with MDD who are unresponsive to SSRIs. Double-blinded trials are warranted to confirm the present findings.

Endoscopic and Open Release Similarly Safe for the Treatment of Carpal Tunnel Syndrome. A Systematic Review and Meta-Analysis

PubMed Central

Vasiliadis, Haris S.; Nikolakopoulou, Adriani; Shrier, Ian; Lunn, Michael P.; Brassington, Ruth; Scholten, Rob J. P.; Salanti, Georgia

2015-01-01

Background The Endoscopic Release of Carpal Tunnel Syndrome (ECTR) is a minimal invasive approach for the treatment of Carpal Tunnel Syndrome. There is scepticism regarding the safety of this technique, based on the assumption that this is a rather “blind” procedure and on the high number of severe complications that have been reported in the literature. Purpose To evaluate whether there is evidence supporting a higher risk after ECTR in comparison to the conventional open release. Methods We searched MEDLINE (January 1966 to November 2013), EMBASE (January 1980 to November 2013), the Cochrane Neuromuscular Disease Group Specialized Register (November 2013) and CENTRAL (2013, issue 11 in The Cochrane Library). We hand-searched reference lists of included studies. We included all randomized or quasi-randomized controlled trials (e.g. study using alternation, date of birth, or case record number) that compare any ECTR with any OCTR technique. Safety was assessed by the incidence of major, minor and total number of complications, recurrences, and re-operations.The total time needed before return to work or to return to daily activities was also assessed. We synthesized data using a random-effects meta-analysis in STATA. We conducted a sensitivity analysis for rare events using binomial likelihood. We judged the conclusiveness of meta-analysis calculating the conditional power of meta-analysis. Conclusions ECTR is associated with less time off work or with daily activities. The assessment of major complications, reoperations and recurrence of symptoms does not favor either of the interventions. There is an uncertain advantage of ECTR with respect to total minor complications (more transient paresthesia but fewer skin-related complications). Future studies are unlikely to alter these findings because of the rarity of the outcome. The effect of a learning curve might be responsible for reduced recurrences and reoperations with ECTR in studies that are more recent, although formal statistical analysis failed to provide evidence for such an association. Level of evidence: I. PMID:26674211

Study design of the influence of SErotonin inhibition on patients with RENAl impairment or diabetes undergoing drug-eluting stent implantation (SERENADE) study: A multicenter, open-label, prospective, randomized study.

PubMed

Lee, Seung-Ah; Suh, Jung-Won; Park, Jin Joo; Yoon, Chang-Hwan; Cho, Young-Suk; Youn, Tae-Jin; Chae, In-Ho; Kim, Hyo-Soo; Kim, Sang-Hyun; Choi, Dong-Ju

2015-07-01

The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643). Copyright © 2015. Published by Elsevier Inc.

Dose reduction of risperidone and olanzapine and estimated dopamine D₂ receptor occupancy in stable patients with schizophrenia: findings from an open-label, randomized, controlled study.

PubMed

Takeuchi, Hiroyoshi; Suzuki, Takefumi; Bies, Robert R; Remington, Gary; Watanabe, Koichiro; Mimura, Masaru; Uchida, Hiroyuki

2014-11-01

While acute-phase antipsychotic response has been attributed to 65%-80% dopamine D₂ receptor blockade, the degree of occupancy for relapse prevention in the maintenance treatment of schizophrenia remains unknown. In this secondary study of an open-label, 28-week, randomized, controlled trial conducted between April 2009 and August 2011, clinically stable patients with schizophrenia (DSM-IV) treated with risperidone or olanzapine were randomly assigned to the reduction group (dose reduced by 50%) or maintenance group (dose kept constant). Plasma antipsychotic concentrations at peak and trough before and after dose reduction were estimated with population pharmacokinetic techniques, using 2 collected plasma samples. Corresponding dopamine D₂ occupancy levels were then estimated using the model we developed. Relapse was defined as worsening in 4 Positive and Negative Syndrome Scale-Positive subscale items: delusion, conceptual disorganization, hallucinatory behavior, and suspiciousness. Plasma antipsychotic concentrations were available for 16 and 15 patients in the reduction and maintenance groups, respectively. Estimated dopamine D₂ occupancy (mean ± SD) decreased following dose reduction from 75.6% ± 4.9% to 66.8% ± 6.4% at peak and 72.3% ± 5.7% to 62.0% ± 6.8% at trough. In the reduction group, 10 patients (62.5%) did not demonstrate continuous D₂ receptor blockade above 65% (ie, < 65% at trough) after dose reduction; furthermore, 7 patients (43.8%) did not achieve a threshold of 65% occupancy even at peak. Nonetheless, only 1 patient met our relapse criteria after dose reduction during the 6 months of the study. The results suggest that the therapeutic threshold regarding dopamine D₂ occupancy may be lower for those who are stable in antipsychotic maintenance versus acute-phase treatment. Positron emission tomography studies are warranted to further test our preliminary findings. UMIN Clinical Trials Registry identifier: UMIN000001834. © Copyright 2014 Physicians Postgraduate Press, Inc.

Endoscopic and Open Release Similarly Safe for the Treatment of Carpal Tunnel Syndrome. A Systematic Review and Meta-Analysis.

PubMed

Vasiliadis, Haris S; Nikolakopoulou, Adriani; Shrier, Ian; Lunn, Michael P; Brassington, Ruth; Scholten, Rob J P; Salanti, Georgia

2015-01-01

The Endoscopic Release of Carpal Tunnel Syndrome (ECTR) is a minimal invasive approach for the treatment of Carpal Tunnel Syndrome. There is scepticism regarding the safety of this technique, based on the assumption that this is a rather "blind" procedure and on the high number of severe complications that have been reported in the literature. To evaluate whether there is evidence supporting a higher risk after ECTR in comparison to the conventional open release. We searched MEDLINE (January 1966 to November 2013), EMBASE (January 1980 to November 2013), the Cochrane Neuromuscular Disease Group Specialized Register (November 2013) and CENTRAL (2013, issue 11 in The Cochrane Library). We hand-searched reference lists of included studies. We included all randomized or quasi-randomized controlled trials (e.g. study using alternation, date of birth, or case record number) that compare any ECTR with any OCTR technique. Safety was assessed by the incidence of major, minor and total number of complications, recurrences, and re-operations.The total time needed before return to work or to return to daily activities was also assessed. We synthesized data using a random-effects meta-analysis in STATA. We conducted a sensitivity analysis for rare events using binomial likelihood. We judged the conclusiveness of meta-analysis calculating the conditional power of meta-analysis. ECTR is associated with less time off work or with daily activities. The assessment of major complications, reoperations and recurrence of symptoms does not favor either of the interventions. There is an uncertain advantage of ECTR with respect to total minor complications (more transient paresthesia but fewer skin-related complications). Future studies are unlikely to alter these findings because of the rarity of the outcome. The effect of a learning curve might be responsible for reduced recurrences and reoperations with ECTR in studies that are more recent, although formal statistical analysis failed to provide evidence for such an association. I.

Comparison of azithromycin plus chloroquine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in children in Africa: a randomized, open-label study.

PubMed

Chandra, Richa; Ansah, Patrick; Sagara, Issaka; Sie, Ali; Tiono, Alfred B; Djimde, Abdoulaye A; Zhao, Qinying; Robbins, Jeffery; Penali, Louis K; Ogutu, Bernhards

2015-03-10

This randomized, open-label study was conducted to establish the non-inferiority of a combination of azithromycin (AZ) and chloroquine (CQ) to artemether-lumefantrine (AL) for treatment of uncomplicated malaria in children from six sites in sub-Saharan Africa. Children with uncomplicated Plasmodium falciparum malaria between six and 59 months of age were randomized 1:1 to either AZCQ (30 mg/kg AZ + 10 mg/kg CQ base) or AL per prescribing information for three days (Days 0, 1, 2). Each site could enrol in the study population once the treatment of uncomplicated malaria in five children five to 12 years of age was deemed to be effective and well tolerated. The primary efficacy evaluation was the proportion of subjects in both the modified intent-to-treat (MITT) and per-protocol (PP) populations with an adequate clinical and parasitological response (PCR corrected) at Day 28. Non-inferiority was concluded if the lower bound of the 95% confidence interval comparing the two groups was 10 percentage points or greater. A total of 255 children were enrolled in the efficacy analysis (AZCQ, n = 124; AL, n = 131). The PCR corrected clearance rates were 89% (AZCQ) versus 98% (AL) for MITT, a difference of -9.10 (95% confidence interval; -16.02, -2.18) and 93% (AZCQ) versus 99% (AL) for PP, a difference of -6.08 (-12.10, -0.05). Early and late treatment failures were more common in subjects receiving AZCQ. Adverse events were more common in subjects treated with AZCQ. Drug concentrations obtained at specified time points following AZCQ administration had a large coefficient of variation partially due to sparse sampling with sample collection time window. In this study, non-inferiority of AZCQ to AL was not demonstrated. ClinicalTrials.gov NCT00677833 .

Neuroendocrine and Inflammatory Responses to Losartan and Continuous Positive Airway Pressure in Patients with Hypertension and Obstructive Sleep Apnea. A Randomized Controlled Trial.

PubMed

Thunström, Erik; Manhem, Karin; Yucel-Lindberg, Tülay; Rosengren, Annika; Lindberg, Caroline; Peker, Yüksel

2016-11-01

Blood pressure reduction in response to antihypertensive agents is less for patients with obstructive sleep apnea (OSA). Increased sympathetic and inflammatory activity, as well as alterations in the renin-angiotensin-aldosterone system, may play a role in this context. To address the cardiovascular mechanisms involved in response to an angiotensin II receptor antagonist, losartan, and continuous positive airway pressure (CPAP) as add-on treatment for hypertension and OSA. Newly diagnosed hypertensive patients with or without OSA (allocated in a 2:1 ratio for OSA vs. no OSA) were treated with losartan 50 mg daily during a 6-week two-center, open-label, prospective, case-control, parallel-design study. In the second 6-week, sex-stratified, open-label, randomized, parallel-design study, all subjects with OSA continued to receive losartan and were randomly assigned to either CPAP as add-on therapy or to no CPAP (1:1 ratio for CPAP vs. no CPAP). Study subjects without OSA were followed in parallel while they continued to take losartan. Blood samples were collected at baseline, after 6 weeks, and after 12 weeks for analysis of renin, aldosterone, noradrenaline, adrenaline, and inflammatory markers. Fifty-four patients with OSA and 35 without OSA were included in the first 6-week study. Losartan significantly increased renin levels and reduced aldosterone levels in the group without OSA. There was no significant decrease in aldosterone levels among patients with OSA. Add-on CPAP treatment tended to lower aldosterone levels, but reductions were more pronounced in measures of sympathetic activity. No significant changes in inflammatory markers were observed following treatment with losartan and CPAP. Hypertensive patients with OSA responded to losartan treatment with smaller reductions in aldosterone compared with hypertensive patients without OSA. Sympathetic system activity seemed to respond primarily to add-on CPAP treatment in patients with newly discovered hypertension and OSA. Clinical trial registered with www.clinicaltrials.gov (NCT00701428).

Does Topical Application of Placental Extract Gel on Postoperative Fibrotomy Wound Improve Mouth Opening and Wound Healing in Patients With Oral Submucous Fibrosis?

PubMed

Thakur, Gagan; Thomas, Shaji; Bhargava, Darpan; Pandey, Ankit

2015-07-01

Placental extract has been used as a therapeutic agent with application in various fields of medicine. Placental extract is well known for its effects on wound healing with anti-inflammatory, antiplatelet, and angiogenic effects and is also a biogenic modulator. The present study evaluated the effect of placental extract on wound healing, mouth opening, and postoperative patient discomfort in patients with oral submucous fibrosis treated with fibrotomy with buccal fat pad coverage and coronoidectomy. Ten subjects with oral submucous fibrosis who presented with mouth opening less than 20 mm were enrolled in the present prospective randomized controlled trial to assess the effects of placental extract on the fibrotomy wound covered with a pedicled buccal pad fat (5 patients allocated to the study group, group S and 5 to the control group, group C). The following criteria were used to analyze the postoperative effect of placental extract on fibrotomy wounds compared with that of the controls: subjective assessment of the wound, postoperative discomfort, and postoperative mouth opening assessed at 1, 2, and 4 weeks postoperatively. The average difference in the preoperative and fourth week postoperative mouth opening for group C was 13.8 ± 2.68 mm and was 21.20 ± 2.77 mm in group S. The median calculated for group C was a 15.0-mm increase in mouth opening and was 20.0 mm in group S. The results obtained with topical application of placental extract on fibrotomy wound healing and postoperative mouth opening were superior to those of the control group in whom placental extract was not used. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Adherence to Preexposure Prophylaxis: Current, Emerging, and Anticipated Bases of Evidence

PubMed Central

Amico, K. Rivet; Stirratt, Michael J.

2014-01-01

Despite considerable discussion and debate about adherence to preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV), scant data are available that characterize patterns of adherence to open-label PrEP. The current evidence base is instead dominated by research on adherence to placebo-controlled investigational drug by way of drug detection in active-arm participants of large randomized controlled trials (RCTs). Important differences between the context of blinded RCTs and open-label use suggest caution when generalizing from study product adherence to real-world PrEP use. Evidence specific to open-label PrEP adherence is presently sparse but will expand rapidly over the next few years as roll-out, demonstration projects, and more rigorous research collect and present findings. The current evidence bases established cannot yet predict uptake, adherence, or persistence with open-label effective PrEP. Emerging evidence suggests that some cohorts could execute better adherence in open-label use vs placebo-controlled research. Uptake of PrEP is presently slow in the United States; whether this changes as grassroots and community efforts increase awareness of PrEP as an effective HIV prevention option remains to be determined. As recommended by multiple guidelines for PrEP use, all current demonstration projects offer PrEP education and/or counseling. PrEP support approaches generally fall into community-based, technology, monitoring, and integrated sexual health promotion approaches. Developing and implementing research that moves beyond simple correlates of either study product use or open-label PrEP adherence toward more comprehensive models of sociobehavioral and socioecological adherence determinants would greatly accelerate progress. Intervention research is needed to identify effective models of support for open-label PrEP adherence. PMID:24926036

Adjunct High Frequency Transcutaneous Electric Stimulation (TENS) for Postoperative Pain Management during Weaning from Epidural Analgesia Following Colon Surgery: Results from a Controlled Pilot Study.

PubMed

Bjerså, Kristofer; Jildenstaal, Pether; Jakobsson, Jan; Egardt, Madelene; Fagevik Olsén, Monika

2015-12-01

The potential benefit of nonpharmacological adjunctive therapy is not well-studied following major abdominal surgery. The aim of the present study was to investigate transcutaneous electrical nerve stimulation (TENS) as a complementary nonpharmacological analgesia intervention during weaning from epidural analgesia (EDA) after open lower abdominal surgery. Patients were randomized to TENS and sham TENS during weaning from EDA. The effects on pain at rest, following short walk, and after deep breath were assessed by visual analog scale (VAS) grading. Number of patients assessed was lower than calculated because of change in clinical routine. Pain scores overall were low. A trend of lower pain scores was observed in the active TENS group of patients; a statistical significance between the groups was found for the pain lying prone in bed (p < .05). This controlled pilot study indicates benefits of TENS use in postoperative pain management during weaning from EDA after open colon surgery. Further studies are warranted in order to verify the potential beneficial effects from TENS during weaning from EDA after open, lower abdominal surgery. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Challenges of the pharmacological management of benzodiazepine withdrawal, dependence, and discontinuation

PubMed Central

Revadigar, Neelambika; Manobianco, Brittany E.

2018-01-01

Background: Benzodiazepines (BZDs) are among the most prescribed sedative hypnotics and among the most misused and abused medications by patients, in parallel with opioids. It is estimated that more than 100 million Benzodiazepine (BZD) prescriptions were written in the United States in 2009. While medically useful, BZDs are potentially dangerous. The co-occurring abuse of opioids and BZD, as well as increases in BZD abuse, tolerance, dependence, and short- and long-term side effects, have prompted a worldwide discussion about the challenging aspects of medically managing the discontinuation of BZDs. Abrupt cessation can cause death. This paper addresses the challenges of medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse and associated medical complications. The focus of this review is on the challenges of several medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse, and associated medical complications. Methods: An electronic search was performed of Medline, Worldwide Science, Directory of Open Access Journals, Embase, Cochrane Library, Google Scholar, PubMed Central, and PubMed from 1990 to 2017. The review includes double-blind, placebo-controlled studies for the most part, open-label pilot studies, and animal studies, in addition to observational research. We expand the search to review articles, naturalistic studies, and to a lesser extent, letters to the editor/case reports. We exclude abstract and poster presentations, books, and book chapters. Results: The efficacy of these medications is not robust. While some of these medicines are relatively safe to use, some of them have a narrow therapeutic index, with severe, life-threatening side effects. Randomized studies have been limited. There is a paucity of comparative research. The review has several limitations. The quality of the documents varies according to whether they are randomized studies, nonrandomized studies, naturalistic studies, pilot studies, letters to the editors, or case reports. Conclusions: The use of medications for the discontinuation of BZDs seems appropriate. It is a challenge that requires further investigation through randomized clinical trials to maximize efficacy and to minimize additional risks and side effects. PMID:29713452

Challenges of the pharmacological management of benzodiazepine withdrawal, dependence, and discontinuation.

PubMed

Fluyau, Dimy; Revadigar, Neelambika; Manobianco, Brittany E

2018-05-01

Benzodiazepines (BZDs) are among the most prescribed sedative hypnotics and among the most misused and abused medications by patients, in parallel with opioids. It is estimated that more than 100 million Benzodiazepine (BZD) prescriptions were written in the United States in 2009. While medically useful, BZDs are potentially dangerous. The co-occurring abuse of opioids and BZD, as well as increases in BZD abuse, tolerance, dependence, and short- and long-term side effects, have prompted a worldwide discussion about the challenging aspects of medically managing the discontinuation of BZDs. Abrupt cessation can cause death. This paper addresses the challenges of medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse and associated medical complications. The focus of this review is on the challenges of several medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse, and associated medical complications. An electronic search was performed of Medline, Worldwide Science, Directory of Open Access Journals, Embase, Cochrane Library, Google Scholar, PubMed Central, and PubMed from 1990 to 2017. The review includes double-blind, placebo-controlled studies for the most part, open-label pilot studies, and animal studies, in addition to observational research. We expand the search to review articles, naturalistic studies, and to a lesser extent, letters to the editor/case reports. We exclude abstract and poster presentations, books, and book chapters. The efficacy of these medications is not robust. While some of these medicines are relatively safe to use, some of them have a narrow therapeutic index, with severe, life-threatening side effects. Randomized studies have been limited. There is a paucity of comparative research. The review has several limitations. The quality of the documents varies according to whether they are randomized studies, nonrandomized studies, naturalistic studies, pilot studies, letters to the editors, or case reports. The use of medications for the discontinuation of BZDs seems appropriate. It is a challenge that requires further investigation through randomized clinical trials to maximize efficacy and to minimize additional risks and side effects.

Hundred-watt-level high power random distributed feedback Raman fiber laser at 1150 nm and its application in mid-infrared laser generation.

PubMed

Zhang, Hanwei; Zhou, Pu; Wang, Xiong; Du, Xueyuan; Xiao, Hu; Xu, Xiaojun

2015-06-29

Two kinds of hundred-watt-level random distributed feedback Raman fiber have been demonstrated. The optical efficiency can reach to as high as 84.8%. The reported power and efficiency of the random laser is the highest one as we know. We have also demonstrated that the developed random laser can be further used to pump a Ho-doped fiber laser for mid-infrared laser generation. Finally, 23 W 2050 nm laser is achieved. The presented laser can obtain high power output efficiently and conveniently and opens a new direction for high power laser sources at designed wavelength.

In Vivo Healing after Capsular Plication in an Ovine Shoulder Model

PubMed Central

Kelly, BT; Turner, AS; Bansal, M; Terry, M; Wolf, BR; Warren, RF; Altchek, DW; Allen, AA

2005-01-01

Traditionally, arthroscopic management of shoulder instability has been reserved for patients with isolated Bankart lesions without any capsular laxity or injury. To date, there are no animal studies evaluating the healing potential of capsular plication and/or capsulo-labral repair. The purpose of this in vivo animal study was to determine if the histological capsular healing of an open capsular plication simulating an arthroscopic plication is equivalent to the more traditional open capsular shift involving cutting and advancing the capsule. Twenty-six skeletally mature sheep were randomized to either an open capsular plication simulating arthroscopic plication (n=13), or an open traditional capsular shift (n=13). A sham operation (n=4) was also performed involving exposure to visualize the capsule. Normal non-operated control shoulders were also analyzed. A pathologist blinded to the treatment evaluated both hematoxylin and eosin (H&E) sections and polarized light microscopy. Qualitative scoring evaluated fibrosis, mucinous degeneration, fat necrosis, granuloma formation, vascularity, inflammatory infiltrate and hemosiderin (0 to 3 points). Both the capsular plication and open shift groups demonstrated healing by fibrosis at the site of surgical manipulation. There were no statistical differences in the capsular healing responses between the two groups with regard to fibrosis, granuloma formation and vascularity. The open shift group demonstrated significantly more mucinous degeneration (p=0.038). Fat necrosis was present in 4/13 specimens in the open shift group and none in the capsular plication specimens. Both groups demonstrated disorganized collagen formation under polarized light microscopy. There were no differences between non-operated control specimens and sham surgery specimens. Our findings support the hypothesis that histologic capsular healing is equivalent between the plication group and the open shift group. In addition, the open shift group demonstrated significantly more changes indicative of tissue injury. This basic science model confirms capsular healing after simulated arthroscopic plication, providing support for arthroscopic capsular plication in practice. PMID:16089080

Correction to: Durability of treatment effects of the sleep position trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial.

PubMed

de Ruiter, Maurits H T; Benoist, Linda B L; de Vries, Nico; de Lange, Jan

2018-05-01

The article "Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial", by M. H. T. de Ruiter et al., was originally published online in SpringerLink on 15 September 2017 without open access.

Quantifying opening-mode fracture spatial organization in horizontal wellbore image logs, core and outcrop: Application to Upper Cretaceous Frontier Formation tight gas sandstones, USA

NASA Astrophysics Data System (ADS)

Li, J. Z.; Laubach, S. E.; Gale, J. F. W.; Marrett, R. A.

2018-03-01

The Upper Cretaceous Frontier Formation is a naturally fractured gas-producing sandstone in Wyoming. Regionally, random and statistically more clustered than random patterns exist in the same upper to lower shoreface depositional facies. East-west- and north-south-striking regional fractures sampled using image logs and cores from three horizontal wells exhibit clustered patterns, whereas data collected from east-west-striking fractures in outcrop have patterns that are indistinguishable from random. Image log data analyzed with the correlation count method shows clusters ∼35 m wide and spaced ∼50 to 90 m apart as well as clusters up to 12 m wide with periodic inter-cluster spacings. A hierarchy of cluster sizes exists; organization within clusters is likely fractal. These rocks have markedly different structural and burial histories, so regional differences in degree of clustering are unsurprising. Clustered patterns correspond to fractures having core quartz deposition contemporaneous with fracture opening, circumstances that some models suggest might affect spacing patterns by interfering with fracture growth. Our results show that quantifying and identifying patterns as statistically more or less clustered than random delineates differences in fracture patterns that are not otherwise apparent but that may influence gas and water production, and therefore may be economically important.

Low-Dose Intravenous Immunoglobulin Treatment for Long-Standing Complex Regional Pain Syndrome: A Randomized Trial.

PubMed

Goebel, Andreas; Bisla, Jatinder; Carganillo, Roy; Frank, Bernhard; Gupta, Rima; Kelly, Joanna; McCabe, Candy; Murphy, Caroline; Padfield, Nick; Phillips, Ceri; Sanders, Mark; Serpell, Mick; Shenker, Nick; Shoukrey, Karim; Wyatt, Lynne; Ambler, Gareth

2017-10-03

Two small trials suggest that low-dose intravenous immunoglobulin (IVIg) may improve the symptoms of complex regional pain syndrome (CRPS), a rare posttraumatic pain condition. To confirm the efficacy of low-dose IVIg compared with placebo in reducing pain during a 6-week period in adult patients who had CRPS from 1 to 5 years. 1:1 parallel, randomized, placebo-controlled, multicenter trial for 6 weeks, with an optional 6-week open extension. Patients were randomly assigned to 1 of 2 study groups between 27 August 2013 and 28 October 2015; the last patient completed follow-up on 21 March 2016. Patients, providers, researchers, and outcome assessors were blinded to treatment assignment. (ISRCTN42179756). 7 secondary and tertiary care pain management centers in the United Kingdom. 111 patients with moderate or severe CRPS of 1 to 5 years' duration. IVIg, 0.5 g/kg of body weight, or visually indistinguishable placebo of 0.1% albumin in saline on days 1 and 22 after randomization. The primary outcome was 24-hour average pain intensity, measured daily between days 6 and 42, on an 11-point (0- to 10-point) rating scale. Secondary outcomes were pain interference and quality of life. The primary analysis sample consisted of 108 eligible patients, 103 of whom had outcome data. Mean (average) pain scores were 6.9 points (SD, 1.5) for placebo and 7.2 points (SD, 1.3) for IVIg. The adjusted difference in means was 0.27 (95% CI, -0.25 to 0.80; P = 0.30), which excluded the prespecified, clinically important difference of -1.2. No statistically significant differences in secondary outcomes were found between the groups. In the open extension, 12 of the 67 patients (18%) who received 2 IVIg infusions had pain reduction of at least 2 points compared with their baseline score. Two patients in the blinded phase (1 in the placebo and 1 in the IVIg group) and 4 in the open IVIg phase had serious events. Results do not apply to patients who have had CRPS for less than 1 year or more than 5 years and do not extend to full-dose treatment (for example, 2 g/kg). The study was inadequately powered to detect subgroup effects. Low-dose immunoglobulin treatment for 6 weeks was not effective in relieving pain in patients with moderate to severe CRPS of 1 to 5 years' duration. Medical Research Council/National Institute for Health Research Efficacy and Mechanism Evaluation Program, Pain Relief Foundation, and Biotest United Kingdom.

Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies

PubMed Central

Burri, Christian; Yeramian, Patrick D.; Merolle, Ada; Serge, Kazadi Kyanza; Mpanya, Alain; Lutumba, Pascal; Mesu, Victor Kande Betu Ku; Lubaki, Jean-Pierre Fina; Mpoto, Alfred Mpoo; Thompson, Mark; Munungu, Blaise Fungula; Josenando, Théophilo; Bernhard, Sonja C.; Olson, Carol A.; Blum, Johannes; Tidwell, Richard R.; Pohlig, Gabriele

2016-01-01

Background Sleeping sickness (human African trypanosomiasis [HAT]) is caused by protozoan parasites and characterized by a chronic progressive course, which may last up to several years before death. We conducted two Phase 2 studies to determine the efficacy and safety of oral pafuramidine in African patients with first stage HAT. Methods The Phase 2a study was an open-label, non-controlled, proof-of-concept study where 32 patients were treated with 100 mg of pafuramidine orally twice a day (BID) for 5 days at two trypanosomiasis reference centers (Angola and the Democratic Republic of the Congo [DRC]) between August 2001 and November 2004. The Phase 2b study compared pafuramidine in 41 patients versus standard pentamidine therapy in 40 patients. The Phase 2b study was open-label, parallel-group, controlled, randomized, and conducted at two sites in the DRC between April 2003 and February 2007. The Phase 2b study was then amended to add an open-label sequence (Phase 2b-2), where 30 patients received pafuramidine for 10 days. The primary efficacy endpoint was parasitologic cure at 24 hours (Phase 2a) or 3 months (Phase 2b) after treatment completion. The primary safety outcome was the rate of occurrence of World Health Organization Toxicity Scale Grade 3 or higher adverse events. All subjects provided written informed consent. Findings/Conclusion Pafuramidine for the treatment of first stage HAT was comparable in efficacy to pentamidine after 10 days of dosing. The cure rates 3 months post-treatment were 79% in the 5-day pafuramidine, 100% in the 7-day pentamidine, and 93% in the 10-day pafuramidine groups. In Phase 2b, the percentage of patients with at least 1 treatment-emergent adverse event was notably higher after pentamidine treatment (93%) than pafuramidine treatment for 5 days (25%) and 10 days (57%). These results support continuation of the development program for pafuramidine into Phase 3. PMID:26881924

Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies.

PubMed

Burri, Christian; Yeramian, Patrick D; Allen, James L; Merolle, Ada; Serge, Kazadi Kyanza; Mpanya, Alain; Lutumba, Pascal; Mesu, Victor Kande Betu Ku; Bilenge, Constantin Miaka Mia; Lubaki, Jean-Pierre Fina; Mpoto, Alfred Mpoo; Thompson, Mark; Munungu, Blaise Fungula; Manuel, Francisco; Josenando, Théophilo; Bernhard, Sonja C; Olson, Carol A; Blum, Johannes; Tidwell, Richard R; Pohlig, Gabriele

2016-02-01

Sleeping sickness (human African trypanosomiasis [HAT]) is caused by protozoan parasites and characterized by a chronic progressive course, which may last up to several years before death. We conducted two Phase 2 studies to determine the efficacy and safety of oral pafuramidine in African patients with first stage HAT. The Phase 2a study was an open-label, non-controlled, proof-of-concept study where 32 patients were treated with 100 mg of pafuramidine orally twice a day (BID) for 5 days at two trypanosomiasis reference centers (Angola and the Democratic Republic of the Congo [DRC]) between August 2001 and November 2004. The Phase 2b study compared pafuramidine in 41 patients versus standard pentamidine therapy in 40 patients. The Phase 2b study was open-label, parallel-group, controlled, randomized, and conducted at two sites in the DRC between April 2003 and February 2007. The Phase 2b study was then amended to add an open-label sequence (Phase 2b-2), where 30 patients received pafuramidine for 10 days. The primary efficacy endpoint was parasitologic cure at 24 hours (Phase 2a) or 3 months (Phase 2b) after treatment completion. The primary safety outcome was the rate of occurrence of World Health Organization Toxicity Scale Grade 3 or higher adverse events. All subjects provided written informed consent. Pafuramidine for the treatment of first stage HAT was comparable in efficacy to pentamidine after 10 days of dosing. The cure rates 3 months post-treatment were 79% in the 5-day pafuramidine, 100% in the 7-day pentamidine, and 93% in the 10-day pafuramidine groups. In Phase 2b, the percentage of patients with at least 1 treatment-emergent adverse event was notably higher after pentamidine treatment (93%) than pafuramidine treatment for 5 days (25%) and 10 days (57%). These results support continuation of the development program for pafuramidine into Phase 3.

Air bubble migration is a random event post embryo transfer.

PubMed

Confino, E; Zhang, J; Risquez, F

2007-06-01

Air bubble location following embryo transfer (ET) is the presumable placement spot of embryos. The purpose of this study was to document endometrial air bubble position and migration following embryo transfer. Multicenter prospective case study. Eighty-eight embryo transfers were performed under abdominal ultrasound guidance in two countries by two authors. A single or double air bubble was loaded with the embryos using a soft, coaxial, end opened catheters. The embryos were slowly injected 10-20 mm from the fundus. Air bubble position was recorded immediately, 30 minutes later and when the patient stood up. Bubble marker location analysis revealed a random distribution without visible gravity effect when the patients stood up. The bubble markers demonstrated splitting, moving in all directions and dispersion. Air bubbles move and split frequently post ET with the patient in the horizontal position, suggestive of active uterine contractions. Bubble migration analysis supports a rather random movement of the bubbles and possibly the embryos. Standing up changed somewhat bubble configuration and distribution in the uterine cavity. Gravity related bubble motion was uncommon, suggesting that horizontal rest post ET may not be necessary. This report challenges the common belief that a very accurate ultrasound guided embryo placement is mandatory. The very random bubble movement observed in this two-center study suggests that a large "window" of embryo placement maybe present.

A Test for Anchoring and Yea-Saying in Experimental Consumption Data.

PubMed

van Soest, Arthur; Hurd, Michael

2008-01-01

We analyze experimental survey data, with a random split into respondents who get an open-ended question on the amount of total family consumption (with follow-up unfolding brackets of the form "Is consumption $X or more?" for those who answer "don't know" or "refuse") and respondents who are immediately directed to unfolding brackets. In both cases, the entry point of the unfolding bracket sequence is randomized. Allowing for any type of selection into answering the open-ended or bracket questions, a nonparametric test is developed for errors in the answers to the first bracket question that are different from the usual reporting errors that will also affect open-ended answers. Two types of errors are considered explicitly: anchoring and yea-saying. Data are collected in the 1995 wave of the Assets and Health Dynamics survey, which is representative of the population in the United States that is 70 years and older. We reject the joint hypothesis of no anchoring and no yea-saying. Once yea-saying is taken into account, we find no evidence of anchoring at the entry point.

A Test for Anchoring and Yea-Saying in Experimental Consumption Data

PubMed Central

van Soest, Arthur; Hurd, Michael

2017-01-01

We analyze experimental survey data, with a random split into respondents who get an open-ended question on the amount of total family consumption (with follow-up unfolding brackets of the form “Is consumption $X or more?” for those who answer “don’t know” or “refuse”) and respondents who are immediately directed to unfolding brackets. In both cases, the entry point of the unfolding bracket sequence is randomized. Allowing for any type of selection into answering the open-ended or bracket questions, a nonparametric test is developed for errors in the answers to the first bracket question that are different from the usual reporting errors that will also affect open-ended answers. Two types of errors are considered explicitly: anchoring and yea-saying. Data are collected in the 1995 wave of the Assets and Health Dynamics survey, which is representative of the population in the United States that is 70 years and older. We reject the joint hypothesis of no anchoring and no yea-saying. Once yea-saying is taken into account, we find no evidence of anchoring at the entry point. PMID:29056797

Surgical approach to gallbladder disease in rural Guatemala.

PubMed

Imran, Jonathan B; Ochoa-Hernandez, Annie; Herrejon, Juan; Madni, Tarik D; Clark, Audra T; Huerta, Sergio

2017-10-01

In this article, we report the current surgical approach to gallbladder disease at a major referral hospital in rural Guatemala. Complications in a cohort of patients undergoing open versus laparoscopic cholecystectomy were catalogued. We reviewed cholecystectomies performed by surgeons at the Hospital Nacional de San Benito in El Peten, Guatemala, after the adoption of the laparoscopic approach. Laparoscopic cholecystectomies (LCs) between 2014 and 2015 (n = 42) were reviewed and matched by 58 randomly selected open cholecystectomies (OCs) during the same period. Patient demographics were similar in the LC and OC groups. Of the 63 patients who had elective surgery, 43 (68%) underwent OC. Conversion rate, hospital length of stay, and readmission rate were 4%, 4.8 days, and 5%, respectively. Complications were similar between groups. Despite the low number of LCs, their complications were not different from that of OCs. During the study period, a large number of cholecystectomies continued to be open, even in the elective setting. Published by Elsevier Inc.

Role of Community in Swachh Bharat Mission. Their Knowledge, Attitude and Practices of Sanitary Latrine Usage in Rural Areas, Tamil Nadu.

PubMed

Anuradha, R; Dutta, Ruma; Raja, J Dinesh; Lawrence, D; Timsi, J; Sivaprakasam, P

2017-01-01

In most developing countries, open defecation is the 'way of life'. This practice is considered as the most serious health and environmental hazard. Prime Minister of India launched the "Swachh Bharat Mission" to accelerate the efforts for achieving universal sanitation coverage and to put focus on sanitation. To find the knowledge, attitude and practices of sanitary latrines usage in rural area, Tamil Nadu. This was a cross sectional study conducted among rural population in Kuthambakkam village, Tamil Nadu. There were a total of 1175 households in Kuthambakkam village. These households were serially numbered and of these a sample of 275 households were selected for the study using simple random sampling technique by lottery method. A structured questionnaire was used to collect information regarding the background characteristics, their knowledge, attitude and practices towards sanitary latrines usage. Descriptive statistics were calculated for background variables, the prevalence of sanitary latrines usage and open air defecation. Association between factors responsible for open air defecation was found by using chi square test. The prevalence of usage of household sanitary latrine and community latrines was 62.5% and 4.3% respectively. The prevalence of open air defecation among the study participants was 33.1%.Significant association was found between low standard of living and open air defecation practice. To solve the problem of underutilization of sanitary latrines, planning and conducting Information Education Communication activities is very essential. Effective political and administrative support is needed to scale up the sanitation program.

Therapeutic effect of increased openness: Investigating mechanism of action in MDMA-assisted psychotherapy

PubMed Central

Wagner, Mark T; Mithoefer, Michael C; Mithoefer, Ann T; MacAulay, Rebecca K; Jerome, Lisa; Yazar-Klosinski, Berra; Doblin, Rick

2017-01-01

A growing body of research suggests that traumatic events lead to persisting personality change characterized by increased neuroticism. Relevantly, enduring improvements in Post-Traumatic Stress Disorder (PTSD) symptoms have been found in response to 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy. There is evidence that lasting changes in the personality feature of “openness” occur in response to hallucinogens, and that this may potentially act as a therapeutic mechanism of change. The present study investigated whether heightened Openness and decreased Neuroticism served as a mechanism of change within a randomized trial of MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD. The Clinician-Administered PTSD Scale (CAPS) Global Scores and NEO PI-R Personality Inventory (NEO) Openness and Neuroticism Scales served as outcome measures. Results indicated that changes in Openness but not Neuroticism played a moderating role in the relationship between reduced PTSD symptoms and MDMA treatment. Following MDMA-assisted psychotherapy, increased Openness and decreased Neuroticism when comparing baseline personality traits with long-term follow-up traits also were found. These preliminary findings suggest that the effect of MDMA-assisted psychotherapy extends beyond specific PTSD symptomatology and fundamentally alters personality structure, resulting in long-term persisting personality change. Results are discussed in terms of possible mechanisms of psychotherapeutic change. PMID:28635375

Productivity and breeding habitat of loggerhead shrikes in a southwestern urban environment

USGS Publications Warehouse

Boal, C.W.; Estabrook, T.S.; Duerr, A.E.

2003-01-01

Declines in loggerhead shrike (Lanius ludovicianus) populations have been associated in part with habitat loss and degradation, including that resulting from urbanization. We monitored the productivity and examined nesting habitat of loggerhead shrikes nesting in an urban environment in Tucson, Arizona. We located 22 breeding pairs in 1997 and 26 breeding pairs in 1998, with a 72% breeding area reoccupancy between years. Mean fledgling numbers were 2.28/ nesting attempt and 3.11/successful nest. Although some pairs initially failed and renested, 91% and 73% of shrike pairs successfully fledged young in 1997 and 1998, respectively. Mayfield estimates of nesting success were 78% in 1997 and 65% in 1998. Nest sites were characterized by more trees >3 m in height, taller nest trees than those randomly available, and a greater proportion of bare ground surface than at random sites. Shrike breeding territories had lower proportions of residential and commercial development and greater proportions of open areas with low-growing vegetation than randomly available. Some shrikes nested in school playgrounds, residential front yards, and parking lots, if adjacent open space was available.

The FIND-CKD study--a randomized controlled trial of intravenous iron versus oral iron in non-dialysis chronic kidney disease patients: background and rationale.

PubMed

Macdougall, Iain C; Bock, Andreas; Carrera, Fernando; Eckardt, Kai-Uwe; Gaillard, Carlo; Van Wyck, David; Roubert, Bernard; Cushway, Timothy; Roger, Simon D

2014-04-01

Rigorous data are sparse concerning the optimal route of administration and dosing strategy for iron therapy with or without concomitant erythropoiesis-stimulating agent (ESA) therapy for the management of iron deficiency anaemia in patients with non-dialysis dependent chronic kidney disease (ND-CKD). FIND-CKD was a 56-week, open-label, multicentre, prospective, randomized three-arm study (NCT00994318) of 626 patients with ND-CKD and iron deficiency anaemia randomized to (i) intravenous (IV) ferric carboxymaltose (FCM) at an initial dose of 1000 mg iron with subsequent dosing as necessary to target a serum ferritin level of 400-600 µg/L (ii) IV FCM at an initial dose of 200 mg with subsequent dosing as necessary to target serum ferritin 100-200 µg/L or (iii) oral ferrous sulphate 200 mg iron/day. The primary end point was time to initiation of other anaemia management (ESA therapy, iron therapy other than study drug or blood transfusion) or a haemoglobin (Hb) trigger (two consecutive Hb values <10 g/dL without an increase of ≥ 0.5 g/dL). The background, rationale and study design of the trial are presented here. The study has been completed and results are expected in late 2013. FIND-CKD was the longest randomized trial of IV iron therapy to date. Its findings will address several unanswered questions regarding iron therapy to treat iron deficiency anaemia in patients with ND-CKD. It was also the first randomized trial to utilize both a high and low serum ferritin target range to adjust IV iron dosing, and the first not to employ Hb response as its primary end point.

[Modern approach to the prevention and treatment of NSAID-gastropathy].

PubMed

Drozdov, V N; Kim, V A; Lazebnik, L B

2011-01-01

The article presents the results of the first Russian open randomized comparative multicenter study on the effectiveness of Famotidine in the prevention of NSAID-gastropathy--Barrier. In addition, were showen the results of studies of the drugs effect used for prevention of NSAID gastropathy (Famotidine, Lansoprazole, Misoprostol) for the synthesis of prostaglandins in the gastric mucosa in patients with osteoarthritis. Was shown the impact of alternative anti-inflammatory drug on the basis of an extract of ginger as joint pain, and the mucous upper gastrointestinal tract in patients with osteoarthritis.

Long-term characteristics of nuclear emulsion

NASA Astrophysics Data System (ADS)

Naganawa, N.; Kuwabara, K.

2010-02-01

Long-term characteristics of the nuclear emulsion so called ``OPERA film'' used in the neutrino oscillation experiment, OPERA, has been studied for 8 years since its production or refreshing after it. In the results, it turned out to be excellent in sensitivity, amount of random noise, and refreshing characteristics. The retention capacity of latent image of tracks was also studied. The result will open the way to the recycling of 7,000,000 emulsion films which will remain not developed after 5 years of OPERA's run, and other long-term experiments with emulsion.

A randomized trial of preoperative oral carbohydrates in abdominal surgery.

PubMed

Sada, Fatos; Krasniqi, Avdyl; Hamza, Astrit; Gecaj-Gashi, Agreta; Bicaj, Besnik; Kavaja, Floren

2014-01-01

Carbohydrate-rich liquid drinks (CRLDs) have been recommended to attenuate insulin resistance by shortening the preoperative fasting interval. The aim of our study the effect of preoperative oral administration of CRLDs on the well-being and clinical status of patients. A randomized, double blind, prospective study of patients undergoing open colorectal operations (CR) and open cholecyctectomy (CH) was conducted. Patients were divided into three groups: study, placebo, and control. Visual analogue scale (VAS) scores for seven parameters (thirst, hunger, anxiety, mouth dryness, nausea, weakness and sleep quality) were recorded and compared for two different time periods (up to 24 h postoperatively and from 36 to 48 h postoperatively). The Simplified Acute Physiology Score changes (SAPS)-II between the three groups were also studied. There were 142 patients American Society of Anesthesiology (ASA) I or II enrolled in the study (CR = 71 and CH = 71). There were no significant differences in postoperative SAPS-II scores or lengths of hospital stay (LOS) between the groups. However, in CR patients, the degree of thirst was partially improved by drinking CRLDs (P = 0.027). In CH patients, on the other hand, feelings of thirst, hunger, mouth dryness, nausea and weakness showed significant improvement (P < 0.05). Oral administration of carbohydrate-rich liquid drinks (CRLDs) improves the well-being in patients undergoing CH, but the effect is less evident in patients undergoing CR. No significant improvements were seen in clinical status or in length of hospital stay in either group. ANZCTR.org.au: ACTRN12614000995673 (registered on 16/09/2014).

Linking big five personality traits to sexuality and sexual health: A meta-analytic review.

PubMed

Allen, Mark S; Walter, Emma E

2018-06-07

This meta-analytic review addresses whether the major dimensions of trait personality relate to components of human sexuality. A comprehensive literature search identified 137 studies that met inclusion criteria (761 effect sizes; total n = 420,595). Pooled mean effects were computed using inverse-variance weighted random effects meta-analysis. Mean effect sizes from 100 separate meta-analyses provided evidence that personality relates to theoretically predicted components of sexuality and sexual health. Neuroticism was positively related to sexual dissatisfaction (r+ = .18), negative emotions (r+ = .42), and symptoms of sexual dysfunction (r+ = .16). Extraversion was positively related to sexual activity (r+ = .17) and risky sexual behavior (r+ = .18), and negatively related to symptoms of sexual dysfunction (r+ = -.17). Openness was positively related to homosexual orientation (r+ = .16) and liberal attitudes toward sex (r+ = .19). Agreeableness and conscientiousness were negatively related to sexually aggressive behavior (r+ = -.20; r+ = -.14) and sexual infidelity (r+ = -.18; r+ = -.17). Less robust evidence indicated that extraversion related negatively, and neuroticism positively, to child sexual abuse, and that openness related negatively to homophobic attitudes. Random effects metaregression identified age, gender, and study quality as important moderators of pooled mean effects. These findings might be of interest to health care professionals developing health care services that aim to promote sexually healthy societies. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Feasibility and effects of a physical exercise programme in adults with myotonic dystrophy type 1: a randomized controlled pilot study.

PubMed

Kierkegaard, Marie; Harms-Ringdahl, Karin; Edström, Lars; Widén Holmqvist, Lotta; Tollbäck, Anna

2011-07-01

To investigate the feasibility and effects of a physical exercise programme on functioning and health-related quality of life in adults with myotonic dystrophy type 1. A randomized controlled trial. Thirty-five adults with myotonic dystrophy type 1. After stratification for level of functioning, study participants were assigned by lot to either a training group or a control group. Training-group participants attended a 60-minute comprehensive group-training programme, Friskis&Svettis® Open Doors, twice a week for 14 weeks. The six-minute walk test was the primary outcome measure and the timed-stands test, the timed up-and-go test, the Epworth sleepiness scale and the Short Form-36 health survey were secondary outcome measures. Intention-to-treat analyses revealed no significant differences in any outcome measures, except for an increased between-group difference after intervention in the Short Form-36 mental health subscale and a decrease in the vitality subscale for the control group. The programme was well tolerated and many training-group participants perceived subjective changes for the better. No negative effects were reported. The Friskis&Svettis® Open Doors programme was feasible for adults with myotonic dystrophy type 1 who had been screened for cardiac involvement, had distal or mild-to-moderate proximal muscle impairment, and no severe cognitive impairments. No beneficial or detrimental effects were evident.

Results of intravenous steroid injection on reduction of postoperative edema in rhinoplasty.

PubMed

Alajmi, Monther Ali; Al-Abdulhadi, Khalid A; Al-Noumas, Hamoud Saud; Kavitha, Gopalan

2009-12-01

To determine the efficacy of intravenous dexamethasone in reducing postrhinoplasty edema. A prospective, randomized clinical trial with placebo control. Department of Otorhinolaryngology, Al-Sabah and Zain Hospital, Kuwait. Eighty-four patients (male = 28; female = 56) aged between 20 and 40 years, undergoing open rhinoplasty with hump removal and bilateral lateral osteotomies were enrolled in this study. Patients were randomized to receive two doses of 10 mg of dexamethasone intravenously or placebo, first dose during surgery and second dose 12 hours after surgery. Patients were evaluated postoperatively at 24 hours, days 2, 5, 7 and 10 for periorbital edema. 10 mg of dexamethasone given intravenously during rhinoplasty and a second dose 12 hours after surgery, reduced postoperative periorbital edema significantly. This study showed a statistically significant benefit of dexamethasone over placebo in reducing periorbital edema after rhinoplasty. No complications were attributed to the administration of dexamethasone.

Experimental vibroacoustic testing of plane panels using synthesized random pressure fields.

PubMed

Robin, Olivier; Berry, Alain; Moreau, Stéphane

2014-06-01

The experimental reproduction of random pressure fields on a plane panel and corresponding induced vibrations is studied. An open-loop reproduction strategy is proposed that uses the synthetic array concept, for which a small array element is moved to create a large array by post-processing. Three possible approaches are suggested to define the complex amplitudes to be imposed to the reproduction sources distributed on a virtual plane facing the panel to be tested. Using a single acoustic monopole, a scanning laser vibrometer and a baffled simply supported aluminum panel, experimental vibroacoustic indicators such as the Transmission Loss for Diffuse Acoustic Field, high-speed subsonic and supersonic Turbulent Boundary Layer excitations are obtained. Comparisons with simulation results obtained using a commercial software show that the Transmission Loss estimation is possible under both excitations. Moreover and as a complement to frequency domain indicators, the vibroacoustic behavior of the panel can be studied in the wave number domain.

Cellular automaton model for molecular traffic jams

NASA Astrophysics Data System (ADS)

Belitsky, V.; Schütz, G. M.

2011-07-01

We consider the time evolution of an exactly solvable cellular automaton with random initial conditions both in the large-scale hydrodynamic limit and on the microscopic level. This model is a version of the totally asymmetric simple exclusion process with sublattice parallel update and thus may serve as a model for studying traffic jams in systems of self-driven particles. We study the emergence of shocks from the microscopic dynamics of the model. In particular, we introduce shock measures whose time evolution we can compute explicitly, both in the thermodynamic limit and for open boundaries where a boundary-induced phase transition driven by the motion of a shock occurs. The motion of the shock, which results from the collective dynamics of the exclusion particles, is a random walk with an internal degree of freedom that determines the jump direction. This type of hopping dynamics is reminiscent of some transport phenomena in biological systems.

Note on Salter's energy absorber in random waves

DOE Office of Scientific and Technical Information (OSTI.GOV)

Serman, D.D.; Mei, C.C.

1980-01-01

Salter's wave theory energy device has been the object of extensive theoretical and experimental studies during recent years. This paper describes the performance of the device in random waves by means of a numerical study. Different situations are considered. First, the cam is allowed to have one degree of freedom (the cam rolls about a rigid and fixed shaft) and is in a shallow sea where the waves are modeled by the JONSWAP spectrum. Power extraction, efficiency and dynamic response are presented in terms of wind characteristics for a cam radius of 3 m. In the open sea where typicalmore » waves are longer and higher, waves are represented by the P-M spectrum and the cam radius is taken to be 7 m. Finally, it is shown for a particular set of design parameters how the efficiency decays and the power extraction decreases with lack of rigidity in the support system.« less

Randomized Effectiveness Study of Four Therapeutic Strategies for TMJ Closed Lock

PubMed Central

Schiffman, E.L.; Look, J.O.; Hodges, J.S.; Swift, J.Q.; Decker, K.L.; Hathaway, K.M.; Templeton, R.B.; Fricton, J.R.

2008-01-01

For individuals with temporomandibular joint (TMJ) disc displacement without reduction with limited mouth opening (closed lock), interventions vary from minimal treatment to surgery. In a single-blind trial, 106 individuals with TMJ closed lock were randomized among medical management, rehabilitation, arthroscopic surgery with post-operative rehabilitation, or arthroplasty with post-operative rehabilitation. Evaluations at baseline, 3, 6, 12, 18, 24, and 60 months used the Craniomandibular Index (CMI) and Symptom Severity Index (SSI) for jaw function and TMJ pain respectively. Using an intention-to-treat analysis, we observed no between-group difference at any follow-up for CMI (p ≥ 0.33) or SSI (p ≥ 0.08). Both outcomes showed within-group improvement (p < 0.0001) for all groups. The findings of this study suggest that primary treatment for individuals with TMJ closed lock should consist of medical management or rehabilitation. The use of this approach will avoid unnecessary surgical procedures. PMID:17189464

Effect of a continuous regimen of contraceptive combination of ethinylestradiol and drospirenone on lipid, carbohydrate and coagulation profiles.

PubMed

Machado, Rogério Bonassi; de Melo, Nilson Roberto; Maia, Hugo; Cruz, Achilles Machado

2010-02-01

The objective of this study was to evaluate the effects of a contraceptive pill containing ethinylestradiol (30 mcg) and drospirenone (3 mg) in a continuous regimen on lipid, carbohydrate and coagulation parameters. This open, prospective, randomized study included 78 participants (mean age 27.8 years) who were randomized into two groups to use the pill continuously for 168 days or for six 28-day cycles with a 7-day hormone-free interval between cycles. Markers of lipid, carbohydrate and coagulation profiles were measured prior to initiation and after the 6 months of pill use. No statistically significant differences were found between the two contraceptive regimens with respect to carbohydrate or lipid profiles or in the parameters related to coagulation. The contraceptive combination of ethinylestradiol and drospirenone used in a continuous regimen was associated with metabolic alterations similar to those found during the traditional cyclic regimen of oral contraceptive use.

What is the effectiveness of the negative pressure wound therapy (NPWT) in patients treated with open abdomen technique? A systematic review and meta-analysis.

PubMed

Cirocchi, Roberto; Birindelli, Arianna; Biffl, Walter L; Mutafchiyski, Ventsislav; Popivanov, Georgi; Chiara, Osvaldo; Tugnoli, Gregorio; Di Saverio, Salomone

2016-09-01

The open abdomen technique may be used in critically ill patients to manage abdominal injury, reduce the septic complications, and prevent the abdominal compartment syndrome. Many different techniques have been proposed and multiple studies have been conducted, but the best method of temporary abdominal closure has not been determined yet. Recently, new randomized and nonrandomized controlled trials have been published on this topic. We aimed to perform an up-to-date systematic review on the management of open abdomen, including the most recent published randomized and nonrandomized controlled trials, to compare negative pressure wound therapy (NPWT) with no NPWT and define if one technique has better outcomes than the other with regard to primary fascial closure, postoperative 30-day mortality and morbidity, enteroatmospheric fistulae, abdominal abscess, bleeding, and length of stay. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and the Cochrane Handbook for Systematic Reviews of Interventions, an online literature research (until July 1, 2015) was performed on MEDLINE, PubMed, Cochrane Central Register of Controlled Trials, and Cochrane Library databases. The MeSH terms and free words used "vacuum assisted closure" "vac;", "open abdomen", "damage control surgery", and "temporary abdominal closure". No language restriction was made. The initial systematic literature search yielded 452 studies. After a careful assessment of the titles and of the full text was obtained, eight articles fulfilled inclusion criteria. We analyzed 1,225 patients, of whom 723 (59%) underwent NPWT and 502 (41%) did not undergo NPWT, and performed four subgroups: VAC versus Bogota bag technique (two studies, 106 participants), VAC versus mesh-foil laparostomy (two studies, 159 participants), VAC versus laparostomy (adhesive impermeable with midline zip) (one study, 106 participants), and NPWT versus no NPWT techniques (three studies, 854 participants) in which it is not possible to perform an analysis of the different types of treatment. Comparing the NPWT group and the group without NPWT, there was no statistically significant difference in fascial closure (63.5% vs 69.5%; odds ratio [OR], 0.74; 95% confidence interval [CI], 0.27-2.06; p = 0.57), postoperative 30-day overall morbidity (p = 0.19), postoperative enteroatmospheric fistulae rate (2.1% vs 5.8%; OR, 0.63; 95% CIs, 0.12-3.15; p = 0.57), in the postoperative bleeding rate (5.7% vs 14.9%; OR, 0.58; 95% CIs, 0.05-6.84; p = 0.87), and postoperative abdominal abscess rate (2.4% vs 5.6%; OR, 0.42; 95% CI, 0.13-1.34; p = 0.14). On the other hand, statistical significance was found between the NPWT group and the group without NPWT in the postoperative mortality rate (28.5% vs 41.4%; OR, 0.46; 95% CI, 0.23-0.91; p = 0.03) and in the length of stay in the intensive care unit (mean difference, -4.53; 95% CI, -5.46 to 3.60; p < 0.00001). The limitations of the present analysis might be related to the lack of randomized controlled trials, so there is a risk of selection bias favoring NPWT. For several outcomes, there were few studies, confidence intervals were wide, and inconsistency was high, suggesting that although there were no statistically significant differences between the groups, there was insufficient evidence to show that the outcomes were similar. We can conclude from the current available data that NPWT seems to be associated with a trend toward better outcomes compared to the use of no NPWT. It does reflect the evidence presented in the current systematic review; however, the data should be interpreted with substantial caution given a number of weaknesses (in particular, the lack of statistical significance and heterogeneity between studies, i.e., small sample size of the included studies, high variability between studies). We highlight the need for randomized controlled trials having homogeneous inclusion criteria to assess the use of NPWT for the management of open abdomen. Systemic review/meta-analysis, level III.

Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial.

PubMed

Pontes, Caridad; Gratacós, Jordi; Torres, Ferran; Avendaño, Cristina; Sanz, Jesús; Vallano, Antoni; Juanola, Xavier; de Miguel, Eugenio; Sanmartí, Raimon; Calvo, Gonzalo

2015-08-20

Dose reduction schedules of tumor necrosis factor antagonists (anti-TNF) as maintenance therapy in patients with spondyloarthritis are used empirically in clinical practice, despite the lack of clinical trials providing evidence for this practice. To address this issue the Spanish Society of Rheumatology (SER) and Spanish Society of Clinical Pharmacology (SEFC) designed a 3-year multicenter, randomized, open-label, controlled clinical trial (2 years for inclusion and 1 year of follow-up). The study is expected to include 190 patients with axial spondyloarthritis on stable maintenance treatment (≥4 months) with any anti-TNF agent at doses recommended in the summary of product characteristics. Patients will be randomized to either a dose reduction arm or maintenance of the dosing regimen as per the official labelling recommendations. Randomization will be stratified according to the anti-TNF agent received before study inclusion. Patient follow-up, visit schedule, and examinations will be maintained as per normal clinical practice recommendations according to SER guidelines. The study aims to test the hypothesis of noninferiority of the dose reduction strategy compared with standard treatment. The first patients were recruited in July 2012, and study completion is scheduled for the end of April 2015. The REDES-TNF study is a pragmatic clinical trial that aims to provide evidence to support a medical decision now made empirically. The study results may help inform clinical decisions relevant to both patients and healthcare decision makers. EudraCT 2011-005871-18 (21 December 2011).

Topical Application of Arnica and Mucopolysaccharide Polysulfate Attenuates Periorbital Edema and Ecchymosis in Open Rhinoplasty: A Randomized Controlled Clinical Study.

PubMed

Simsek, Gokce; Sari, Elif; Kilic, Rahmi; Bayar Muluk, Nuray

2016-03-01

The purpose of this study was to investigate the effects of local arnica and mucopolysaccharide polysulfate treatment on the regression of postoperative edema and ecchymosis in patients who have undergone open technique rhinoplasty. One hundred eight patients were included in the study. Participants were randomized into three groups, all of whom had undergone rhinoplasty. Group 1 (n = 36) received postoperative arnica cream treatment, and group 2 (n = 36) received postoperative mucopolysaccharide polysulfate cream treatment. Group 3 (n = 36, control group) consisted of patients who received no postoperative local treatments. Patients were evaluated for 24 hours on days 2, 5, 7, and 10 after the operation. For the evaluation of postoperative edema and ecchymosis, a scale ranging from 0 to 4 was used, and the groups were compared. In groups 1 and 2, postoperative ecchymosis was significantly less than in the control group during postoperative days 1, 5, and 7 (p < 0.005). The regression of the edema was also more rapid in groups 1 and 2 than in the control group during evaluations on postoperative days 1, 5, and 7 (p < 0.005). Neither edema nor ecchymosis was significantly different between groups 1 and 2 (p > 0.005). The authors' results suggest that a rapid regression of edema and ecchymosis may be achieved by local treatments of arnica and mucopolysaccharide polysulfate cream. In addition, there are no significant differences between these two treatment regimens. Therapeutic, II.

Open, randomized trial of the effects of aripiprazole versus risperidone on social cognition in schizophrenia.

PubMed

Maat, Arija; Cahn, Wiepke; Gijsman, Harm J; Hovens, Johannes E; Kahn, René S; Aleman, André

2014-04-01

To date, only few studies have examined the impact of medication on social cognition and none have examined the effects of aripiprazole in this respect. The goal of this 8-week, randomized, multicenter, open-label study was to examine the effects of aripiprazole and risperidone on social cognition and neurocognition in individuals with schizophrenia. Eighty schizophrenia patients (DSM-IV-TR) aged 16-50 years were administered multiple computerized measures of social cognition and neurocognition including reaction times at baseline and the end of week 8. Social functioning was mapped with the Social Functioning scale and Quality of Life scale. The study ran from June 2005 to March 2011. Scores on social cognitive and neurocognitive tests improved with both treatments, as did reaction time. There were few differences between the two antipsychotics on (social) cognitive test-scores. The aripiprazole group performed better (more correct items) on symbol substitution (P=.003). Aripiprazole was also superior to risperidone on reaction time for emotional working memory and working memory (P=.006 and P=.023, respectively). Improvements on these tests were correlated with social functioning. In conclusion, aripiprazole and risperidone showed a similar impact on social cognitive test-scores. However, aripiprazole treatment produced a greater effect on patients' processing speed compared to risperidone, with these improvements being associated with concurrent improvements in social functioning. Further research on the long-term effects of aripiprazole on cognition is warranted. Copyright © 2014 Elsevier B.V. and ECNP. All rights reserved.

Entanglement dynamics in random media

NASA Astrophysics Data System (ADS)

Menezes, G.; Svaiter, N. F.; Zarro, C. A. D.

2017-12-01

We study how the entanglement dynamics between two-level atoms is impacted by random fluctuations of the light cone. In our model the two-atom system is envisaged as an open system coupled with an electromagnetic field in the vacuum state. We employ the quantum master equation in the Born-Markov approximation in order to describe the completely positive time evolution of the atomic system. We restrict our investigations to the situation in which the atoms are coupled individually to two spatially separated cavities, one of which displays the emergence of light-cone fluctuations. In such a disordered cavity, we assume that the coefficients of the Klein-Gordon equation are random functions of the spatial coordinates. The disordered medium is modeled by a centered, stationary, and Gaussian process. We demonstrate that disorder has the effect of slowing down the entanglement decay. We conjecture that in a strong-disorder environment the mean life of entangled states can be enhanced in such a way as to almost completely suppress quantum nonlocal decoherence.

Low-order black-box models for control system design in large power systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kamwa, I.; Trudel, G.; Gerin-Lajoie, L.

1996-02-01

The paper studies two multi-input multi-output (MIMO) procedures for the identification of low-order state-space models of power systems, by probing the network in open loop with low-energy pulses or random signals. Although such data may result from actual measurements, the development assumes simulated responses from a transient stability program, hence benefiting from the existing large base of stability models. While pulse data is processed using the eigensystem realization algorithm, the analysis of random responses is done by means of subspace identification methods. On a prototype Hydro-Quebec power system, including SVCs, DC lines, series compensation, and more than 1,100 buses, itmore » is verified that the two approaches are equivalent only when strict requirements are imposed on the pulse length and magnitude. The 10th-order equivalent models derived by random-signal probing allow for effective tuning of decentralized power system stabilizers (PSSs) able to damp both local and very slow inter-area modes.« less

Low-order black-box models for control system design in large power systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kamwa, I.; Trudel, G.; Gerin-Lajoie, L.

1995-12-31

The paper studies two multi-input multi-output (MIMO) procedures for the identification of low-order state-space models of power systems, by probing the network in open loop with low-energy pulses or random signals. Although such data may result from actual measurements, the development assumes simulated responses from a transient stability program, hence benefiting form the existing large base of stability models. While pulse data is processed using the eigensystem realization algorithm, the analysis of random responses is done by means of subspace identification methods. On a prototype Hydro-Quebec power system, including SVCs, DC lines, series compensation, and more than 1,100 buses, itmore » is verified that the two approaches are equivalent only when strict requirements are imposed on the pulse length and magnitude. The 10th-order equivalent models derived by random-signal probing allow for effective tuning of decentralized power system stabilizers (PSSs) able to damp both local and very slow inter-area modes.« less

Memory in random bouncing ball dynamics

NASA Astrophysics Data System (ADS)

Zouabi, C.; Scheibert, J.; Perret-Liaudet, J.

2016-09-01

The bouncing of an inelastic ball on a vibrating plate is a popular model used in various fields, from granular gases to nanometer-sized mechanical contacts. For random plate motion, so far, the model has been studied using Poincaré maps in which the excitation by the plate at successive bounces is assumed to be a discrete Markovian (memoryless) process. Here, we investigate numerically the behaviour of the model for continuous random excitations with tunable correlation time. We show that the system dynamics are controlled by the ratio of the Markovian mean flight time of the ball and the mean time between successive peaks in the motion of the exciting plate. When this ratio, which depends on the bandwidth of the excitation signal, exceeds a certain value, the Markovian approach is appropriate; below, memory of preceding excitations arises, leading to a significant decrease of the jump duration; at the smallest values of the ratio, chattering occurs. Overall, our results open the way for uses of the model in the low-excitation regime, which is still poorly understood.

'Pharyngocise': Randomized Controlled Trial of Preventative Exercises to Maintain Muscle Structure and Swallowing Function During Head-and-Neck Chemoradiotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Carnaby-Mann, Giselle, E-mail: gmann@phhp.ufl.edu; Crary, Michael A.; Schmalfuss, Ilona

2012-05-01

Purpose: Dysphagia after chemoradiotherapy is common. The present randomized clinical trial studied the effectiveness of preventative behavioral intervention for dysphagia compared with the 'usual care.' Methods and Materials: A total of 58 head-and-neck cancer patients treated with chemoradiotherapy were randomly assigned to usual care, sham swallowing intervention, or active swallowing exercises (pharyngocise). The intervention arms were treated daily during chemoradiotherapy. The primary outcome measure was muscle size and composition (determined by T{sub 2}-weighted magnetic resonance imaging). The secondary outcomes included functional swallowing ability, dietary intake, chemosensory function, salivation, nutritional status, and the occurrence of dysphagia-related complications. Results: The swallowing musculaturemore » (genioglossus, hyoglossuss, and mylohyoid) demonstrated less structural deterioration in the active treatment arm. The functional swallowing, mouth opening, chemosensory acuity, and salivation rate deteriorated less in the pharyngocise group. Conclusion: Patients completing a program of swallowing exercises during cancer treatment demonstrated superior muscle maintenance and functional swallowing ability.« less

Comparison of Temporary Open Arterial Revascularization Using Stent Grafts vs. Standard Vascular Shunts in a Porcine (Sus scrofa) Model

DTIC Science & Technology

2017-01-24

Objectives: Open surgical reconstruction using expanded polytetrafluoroethylene stent grafts to create a sutureless anastomosis is an alternative to...French Argyle shunt was inserted into one randomly assigned artery, with a self-expanding ePTFE stent deployed in the other. Arterial flow measurements...for histopathology were obtained during the terminal procedure. Results: Angiography revealed no difference in patency at 72 hours. The stent grafts

Multicenter Randomized Controlled Trial on Duration of Therapy for Thrombosis in Children and Young Adults (Kids-DOTT): Pilot/Feasibility Phase Findings

PubMed Central

Goldenberg, N.A.; Abshire, T.; Blatchford, P.J.; Fenton, L.Z.; Halperin, J.L.; Hiatt, W.R.; Kessler, C.M.; Kittelson, J.M.; Manco-Johnson, M.J.; Spyropoulos, A.C.; Steg, P.G.; Stence, N.V.; Turpie, A.G.G.; Schulman, S.

2015-01-01

BACKGROUND Randomized controlled trials (RCTs) in pediatric venous thromboembolism (VTE) treatment have been challenged by unsubstantiated design assumptions and/or poor accrual. Pilot/feasibility (P/F) studies are critical to future RCT success. METHODS Kids-DOTT is a multicenter RCT investigating non-inferiority of a 6-week (shortened) vs. 3-month (conventional) duration of anticoagulation in patients <21 years old with provoked venous thrombosis. Primary efficacy and safety endpoints are symptomatic recurrent VTE at 1 year and anticoagulant-related, clinically-relevant bleeding. In the P/F phase, 100 participants were enrolled in an open, blinded endpoint, parallel-cohort RCT design. RESULTS No eligibility violations or randomization errors occurred. Of enrolled patients, 69% were randomized, 3% missed the randomization window, and 28% were followed in pre-specified observational cohorts for completely occlusive thrombosis or persistent antiphospholipid antibodies. Retention at 1 year was 82%. Inter-observer agreement between local vs. blinded central determination of venous occlusion by imaging at 6 weeks post-diagnosis was strong (κ-statistic=0.75; 95% confidence interval [CI] 0.48–1.0). Primary efficacy and safety event rates were 3.3% (95% CI 0.3–11.5%) and 1.4% (0.03–7.4%). CONCLUSIONS The P/F phase of Kids-DOTT has demonstrated validity of vascular imaging findings of occlusion as a randomization criterion, and defined randomization, retention, and endpoint rates to inform the fully-powered RCT. PMID:26118944

Efficacy and tolerability of quetiapine in the treatment of bipolar disorder: preliminary evidence from a 12-month open-label study.

PubMed

Altamura, A C; Salvadori, Daniele; Madaro, Donato; Santini, Annalisa; Mundo, Emanuela

2003-09-01

The literature on the use of quetiapine for the treatment of bipolar disorder (BD) is limited to case reports, and there are no systematic studies on the efficacy of quetiapine in the prophylactic treatment of BD. The aim of the present study was to compare the efficacy of flexible doses of quetiapine and well established mood stabilizers in the maintenance treatment of BD. Twenty-eight DSM-IV BD outpatients were consecutively recruited into the study and were randomized to receive one of two open-label treatments, with quetiapine or classical mood stabilizers at flexible doses for 12 months. Clinical assessment was carried out using BPRS, CGI, YMRS and the 21-item HAM-D at baseline (T0) and every 2 months until the end of the study. ANOVAs with repeated measures were applied to the rating scale scores considering the time and the treatment group as main factors. All patients experienced a significant improvement on the BPRS, CGI and HAM-D scores, with no significant side-effects and a good compliance. This study should be considered preliminary given the small sample size investigated and the open-label design. If these results will be replicated on larger samples and in controlled studies, there could be relevant implications for the use of quetiapine as an alternative maintenance treatment for BD.

Flexible random lasers with tunable lasing emissions.

PubMed

Lee, Ya-Ju; Chou, Chun-Yang; Yang, Zu-Po; Nguyen, Thi Bich Hanh; Yao, Yung-Chi; Yeh, Ting-Wei; Tsai, Meng-Tsan; Kuo, Hao-Chun

2018-04-19

In this study, we experimentally demonstrated a flexible random laser fabricated on a polyethylene terephthalate (PET) substrate with a high degree of tunability in lasing emissions. Random lasing oscillation arises mainly from the resonance coupling between the emitted photons of gain medium (Rhodamine 6G, R6G) and the localized surface plasmon (LSP) of silver nanoprisms (Ag NPRs), which increases the effective cross-section for multiple light scattering, thus stimulating the lasing emissions. More importantly, it was found that the random lasing wavelength is blue-shifted monolithically with the increase in bending strains exerted on the PET substrate, and a maximum shift of ∼15 nm was achieved in the lasing wavelength, when a 50% bending strain was exerted on the PET substrate. Such observation is highly repeatable and reversible, and this validates that we can control the lasing wavelength by simply bending the flexible substrate decorated with the Ag NPRs. The scattering spectrum of the Ag NPRs was obtained using a dark-field microscope to understand the mechanism for the dependence of the wavelength shift on the exerted bending strains. As a result, we believe that the experimental demonstration of tunable lasing emissions based on the revealed structure is expected to open up a new application field of random lasers.

Randomized Controlled Trial Evaluating a Standardized Strategy for Uveitis Etiologic Diagnosis (ULISSE).

PubMed

de Parisot, Audrey; Kodjikian, Laurent; Errera, Marie-Hélène; Sedira, Neila; Heron, Emmanuel; Pérard, Laurent; Cornut, Pierre-Loïc; Schneider, Christelle; Rivière, Sophie; Ollé, Priscille; Pugnet, Grégory; Cathébras, Pascal; Manoli, Pierre; Bodaghi, Bahram; Saadoun, David; Baillif, Stéphanie; Tieulie, Nathalie; Andre, Marc; Chiambaretta, Frédéric; Bonin, Nicolas; Bielefeld, Philip; Bron, Alain; Mouriaux, Frédéric; Bienvenu, Boris; Vicente, Stéphanie; Bin, Sylvie; Broussolle, Christiane; Decullier, Evelyne; Sève, Pascal

2017-06-01

To prospectively assess the efficiency of a standardized diagnostic approach, compared to an open strategy, for the etiologic diagnosis of uveitis. Noninferiority, prospective, multicenter, clustered randomized controlled trial. Consecutive patients with uveitis, who visited 1 of the participating departments of ophthalmology, were included. In the standardized group, all patients had a minimal evaluation regardless of the type of uveitis (complete blood count, erythrocyte sedimentation rate, C-reactive protein, tuberculin skin test, syphilis serology, and chest radiograph) followed by more complex investigations according to ophthalmologic findings. In the open group, the ophthalmologist could order any type of investigation. Main outcome was the percentage of etiologic diagnoses at 6 months. Nine hundred and three patients with uveitis were included from January 2010 to May 2013 and the per-protocol population comprised 676 patients (open 373; standardized 303). Mean age at diagnosis was 46 years. Anatomic distribution of uveitis was as follows: anterior (60.8% and 72.3%, P = .0017), intermediate (11.7% and 12.3%, P = .8028), posterior (17.8% and 8.2%, P = .0004), and panuveitis (15.3% and 15.2%, P = .9596). An etiologic diagnosis was established in 54.4% of cases in the open group and 49.5% in the standardized group (P = .2029). The difference between both strategies (standardized minus open) was -4.9% (95% CI [-12.5%; 2.6%]). There were more investigations in the open group than in the standardized group (5371 vs 3759, P < .0001). The standardized strategy appears to be an efficient diagnostic approach for the etiologic diagnosis of uveitis, although its noninferiority cannot be proved. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of a technique using a new percutaneous osteosynthesis device with conventional open surgery for displaced patella fractures in a randomized controlled trial.

PubMed

Luna-Pizarro, Daniel; Amato, Dante; Arellano, Francisco; Hernández, Armando; López-Rojas, Pablo

2006-09-01

To compare the percutaneous patellar osteosynthesis system (PPOS) technique with open surgery for patella fractures. Randomized controlled trial. Referral orthopedic and trauma center. Fifty-three patients with displaced patellar fractures. Stabilization and fixation of patellar fractures with PPOS or open surgery. Knee-flexion and -extension angles, pain, surgical time, and assessment of knee function based on the Knee Society Clinical Rating Scale (KSCRS). Comparison of PPOS and open-surgery groups at 4 weeks showed the following: pain, 3.7 +/- 1.6 versus 6.2 +/- 1.4 arbitrary units, P < 0.001; flexion angle, 46 +/- 20.7 versus 12.7 +/- 6.0 degrees, P < 0.001; extension angle, -2.5 versus -3.8 degrees, P < 0.001. At 8 weeks, the following was demonstrated: pain, 1.3 +/- 1.6 versus 4.1 +/- 2.1 arbitrary units, P < 0.001; flexion angle, 87 +/- 17.3 versus 34 +/- 26 degrees, P < 0.001; extension angle, 0 versus -3 degrees, P < 0.001. Surgical time was 35.3 +/- 7.8 versus 66.2 +/- 14.1 minutes, P < 0.001. KSCRS assessment was 84 +/- 4 versus 70 +/- 8, P < 0.001 at 8 weeks; 85 +/- 2 versus 73 +/- 8, P < 0.001 at 12 months; and 85 +/- 1 versus 82 +/- 7, P = 0.246 at 24 months. Frequency of total complications (infections, fragment displacement, and wire-related pain) was significantly lower in the PPOS than in the open-surgery group (P < 0.02). PPOS for patella fractures was associated with shorter surgical time, less pain, better mobility angles, higher functional score up to 2 years, and a lower incidence of complications than open surgery.

Transfer of preterm infants from incubator to open cot at lower versus higher body weight.

PubMed

New, K; Flenady, V; Davies, M W

2008-01-23

The use of incubators in helping to maintain a thermoneutral environment for preterm infants has become routine practice in neonatal nurseries. As one of the key criteria for discharging preterm infants from nurseries is their ability to maintain temperature; the infant will need to make the transition from incubator to open cot at some time before discharge. The timing of this transition is important because, when an infant is challenged by cold, the infant attempts to increase its heat production to maintain body temperature. The increase in energy expenditure may affect weight gain. The practice of transferring infants from incubators to open cots usually occurs once a weight of around 1700 - 1800 g has been reached; however, this practice varies widely among neonatal units. This target weight appears to be largely based on tradition or the personal experience of clinicians, with little consideration of the infant's weight or gestational age at birth. The main objective was to assess the effects on weight gain and temperature control of a policy of transferring preterm infants from incubator to open cot at lower versus higher body weight. Searches were undertaken of MEDLINE from April 2007 back to 1950, CINAHL from April 2007 back to 1982 and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2007). The title and abstract of each retrieved study were examined to assess eligibility. If there was uncertainty, the full paper was examined. Trials in which preterm infants were allocated to a policy of transfer from incubators to open cots at a lower body weight versus at a higher body weight. Quality assessments and data extraction for included trials were conducted independently by the reviewers. Data for individual trial results were analysed using relative risk (RR) and mean difference (MD). Results are presented with 95% confidence intervals (CI). Due to insufficient data, meta-analysis could not be undertaken. Five studies were identified as potentially eligible for inclusion in this review. Three studies were excluded as neither random nor quasi-random allocation to the exposure was employed. Two small quasi-randomised studies, involving 74 preterm infants are included in this review. These studies compared the transfer of infants to open cots at 1600 - 1700 g vs. 1800- 1900 g, and 1700 g vs. 1800 g. Data for only two prespecified outcomes could be included in this review. No statistically significant difference was shown for either return to incubator [one trial (N = 60) RR 2.00; 95% CI 0.40 to 10.11] or daily weight gain measured in g/kg/day [one trial (N = 14) MD 1.00 g/kg/day; 95% CI -2.89, 4.89]. Due to insufficient data, meta-analysis was not performed and effects on clinically important outcomes could not be adequately assessed. There is currently little evidence from randomised trials to inform practice on the preferred weight for transferring preterm infants from incubators to open cots. There is a need for larger randomised controlled trials to address this deficiency.

Deterministic diffusion in flower-shaped billiards.

PubMed

Harayama, Takahisa; Klages, Rainer; Gaspard, Pierre

2002-08-01

We propose a flower-shaped billiard in order to study the irregular parameter dependence of chaotic normal diffusion. Our model is an open system consisting of periodically distributed obstacles in the shape of a flower, and it is strongly chaotic for almost all parameter values. We compute the parameter dependent diffusion coefficient of this model from computer simulations and analyze its functional form using different schemes, all generalizing the simple random walk approximation of Machta and Zwanzig. The improved methods we use are based either on heuristic higher-order corrections to the simple random walk model, on lattice gas simulation methods, or they start from a suitable Green-Kubo formula for diffusion. We show that dynamical correlations, or memory effects, are of crucial importance in reproducing the precise parameter dependence of the diffusion coefficent.

Peer Review Quality and Transparency of the Peer-Review Process in Open Access and Subscription Journals.

PubMed

Wicherts, Jelte M

2016-01-01

Recent controversies highlighting substandard peer review in Open Access (OA) and traditional (subscription) journals have increased the need for authors, funders, publishers, and institutions to assure quality of peer-review in academic journals. I propose that transparency of the peer-review process may be seen as an indicator of the quality of peer-review, and develop and validate a tool enabling different stakeholders to assess transparency of the peer-review process. Based on editorial guidelines and best practices, I developed a 14-item tool to rate transparency of the peer-review process on the basis of journals' websites. In Study 1, a random sample of 231 authors of papers in 92 subscription journals in different fields rated transparency of the journals that published their work. Authors' ratings of the transparency were positively associated with quality of the peer-review process but unrelated to journal's impact factors. In Study 2, 20 experts on OA publishing assessed the transparency of established (non-OA) journals, OA journals categorized as being published by potential predatory publishers, and journals from the Directory of Open Access Journals (DOAJ). Results show high reliability across items (α = .91) and sufficient reliability across raters. Ratings differentiated the three types of journals well. In Study 3, academic librarians rated a random sample of 140 DOAJ journals and another 54 journals that had received a hoax paper written by Bohannon to test peer-review quality. Journals with higher transparency ratings were less likely to accept the flawed paper and showed higher impact as measured by the h5 index from Google Scholar. The tool to assess transparency of the peer-review process at academic journals shows promising reliability and validity. The transparency of the peer-review process can be seen as an indicator of peer-review quality allowing the tool to be used to predict academic quality in new journals.

Peer Review Quality and Transparency of the Peer-Review Process in Open Access and Subscription Journals

PubMed Central

Wicherts, Jelte M.

2016-01-01

Background Recent controversies highlighting substandard peer review in Open Access (OA) and traditional (subscription) journals have increased the need for authors, funders, publishers, and institutions to assure quality of peer-review in academic journals. I propose that transparency of the peer-review process may be seen as an indicator of the quality of peer-review, and develop and validate a tool enabling different stakeholders to assess transparency of the peer-review process. Methods and Findings Based on editorial guidelines and best practices, I developed a 14-item tool to rate transparency of the peer-review process on the basis of journals’ websites. In Study 1, a random sample of 231 authors of papers in 92 subscription journals in different fields rated transparency of the journals that published their work. Authors’ ratings of the transparency were positively associated with quality of the peer-review process but unrelated to journal’s impact factors. In Study 2, 20 experts on OA publishing assessed the transparency of established (non-OA) journals, OA journals categorized as being published by potential predatory publishers, and journals from the Directory of Open Access Journals (DOAJ). Results show high reliability across items (α = .91) and sufficient reliability across raters. Ratings differentiated the three types of journals well. In Study 3, academic librarians rated a random sample of 140 DOAJ journals and another 54 journals that had received a hoax paper written by Bohannon to test peer-review quality. Journals with higher transparency ratings were less likely to accept the flawed paper and showed higher impact as measured by the h5 index from Google Scholar. Conclusions The tool to assess transparency of the peer-review process at academic journals shows promising reliability and validity. The transparency of the peer-review process can be seen as an indicator of peer-review quality allowing the tool to be used to predict academic quality in new journals. PMID:26824759

Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial.

PubMed

Suzuki, Kazuyuki; Endo, Ryujin; Takikawa, Yasuhiro; Moriyasu, Fuminori; Aoyagi, Yutaka; Moriwaki, Hisataka; Terai, Shuji; Sakaida, Isao; Sakai, Yoshiyuki; Nishiguchi, Shuhei; Ishikawa, Toru; Takagi, Hitoshi; Naganuma, Atsushi; Genda, Takuya; Ichida, Takafumi; Takaguchi, Koichi; Miyazawa, Katsuhiko; Okita, Kiwamu

2018-05-01

The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out. Subjects with grade I or II HE and hyperammonemia were enrolled. The phase II/III study, which was a randomized, evaluator-blinded, active-comparator, parallel-group study, was undertaken at 37 institutions in Japan. Treatment periods were 14 days. Eligible patients were randomized to the rifaximin group (1200 mg/day) or the lactitol group (18-36 g/day). The phase III study was carried out in the same patients previously enrolled in the phase II/III study, and they were all treated with rifaximin (1200 mg/day) for 10 weeks. In the phase II/III study, 172 patients were enrolled. Blood ammonia (B-NH 3 ) concentration was significantly improved in the rifaximin group, but the difference between the two groups was not significant. The portal systemic encephalopathy index (PSE index), including HE grade, was significantly improved in both groups. In the phase III study, 87.3% of enrolled patients completed the treatment. The improved B-NH 3 concentration and PSE index were well maintained from the phase II/III study during the treatment period of the phase III study. Adverse drug reactions (ADRs) were seen in 13.4% of patients who received rifaximin, but there were no severe ADRs leading to death. The efficacy of rifaximin is sufficient and treatment is well tolerated in Japanese patients with HE and hyperammonemia. © 2017 The Japan Society of Hepatology.

The effectiveness of a cognitive task analysis informed curriculum to increase self-efficacy and improve performance for an open cricothyrotomy.

PubMed

Campbell, Julia; Tirapelle, Leslie; Yates, Kenneth; Clark, Richard; Inaba, Kenji; Green, Donald; Plurad, David; Lam, Lydia; Tang, Andrew; Cestero, Ramon; Sullivan, Maura

2011-01-01

This study explored the effects of a cognitive task analysis (CTA)-informed curriculum to increase surgical skills performance and self-efficacy beliefs for medical students and postgraduate surgical residents learning how to perform an open cricothyrotomy. Third-year medical students and postgraduate year 2 and 3 surgery residents were assigned randomly to either the CTA group (n = 12) or the control group (n = 14). The CTA group learned the open cricothyrotomy procedure using the CTA curriculum. The control group received the traditional curriculum. The CTA group outperformed the control group significantly based on a 19-point checklist score (CTA mean score: 17.75, standard deviation [SD] = 2.34; control mean score: 15.14, SD = 2.48; p = 0.006). The CTA group also reported significantly higher self-efficacy scores based on a 140-point self-appraisal inventory (CTA mean score: 126.10, SD = 16.90; control: 110.67, SD = 16.8; p = 0.029). The CTA curriculum was effective in increasing the performance and self-efficacy scores for postgraduate surgical residents and medical students performing an open cricothyrotomy. Copyright © 2011 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Study of Pharmacodynamic and Pharmacokinetic Interaction of Bojungikki-Tang with Aspirin in Healthy Subjects and Ischemic Stroke Patients

PubMed Central

Yoo, Jung-Hwa; Yim, Sung-Vin

2018-01-01

Background Bojungikki-tang (BJIKT) is a widely used traditional herbal formula in China, Japan, and Korea. There have been reports that several herbs among BJIKT have interactions with antiplatelet drugs, such as aspirin. This study aimed to assess whether BJIKT interacts with aspirin in terms of pharmacokinetics (PK) and pharmacodynamics (PD) in healthy subjects and ischemic stroke patients. Methods The phase I interaction trial was a randomized, open-label, crossover study of 10 healthy male subjects, and the phase III interaction trial was a randomized, placebo-controlled, parallel study of 43 ischemic stroke patients. Each participant randomly received aspirin + BJIKT or aspirin + placebo. For PK analysis, plasma acetyl salicylic acid (ASA) and salicylic acid (SA) were evaluated, and, for PD analysis, platelet aggregation and plasma thromboxane B2 (TxB2) were measured. Results In the PK parameters, mean area under curve, maximum concertation, and peak concentration time of ASA and SA were not different between two groups in healthy subjects and ischemic stroke patients. In the PD profiles, TxB2 concentrations and platelet aggregation were not affected by coadministration of BJIKT in healthy subjects and ischemic stroke patients. Conclusions These results suggest that coadministration of BJIKT with aspirin may not result in herb-drug interaction. PMID:29599812