Trial Sessions Research Articles

Alles naar wens? Observaties naar aanleiding van het conceptwetsvoorstel ter aanvulling van het spreekrecht voor slachtoffers en nabestaanden in het strafproces

Since 2005, Dutch victims of serious crime have the right to make an oral statement in court (‘spreekrecht’). In the past decade, the Dutch criminal justice system has accommodated this right to make an oral statement with regard to the consequences of the crime; no major problems have occurred. Indeed, only a minority of the victims consumes this right (ca. 230 cases annually), the majority prefers to lodge a written statement. Nevertheless, the Dutch legislature is of the opinion that the right to make an oral statement should be extended and has lodged a draft-proposal recently. The aim is to provide crime victims a right to put forward an advice to the judge at the trial session, such an advice relating to the full scheme of judicial decision-making (truth, legal qualification, punishment). Such a provision resembles a Victim Statement of Opinion, used in the American scheme of justice, and even exceeds this. The draft has been met with criticism, only the Dutch Victim Support is in favor. One of the objections heard is the one dimensional focus underlying the draft: by focusing on a specific group of victims – those who have suffered from serious crimes – the legislature neglects the heterogeneous nature of victims’ needs.

63rd Annual Scientific Sessions of the American College of Cardiology: 29-31 March 2014; Washington, DC, USA.

The Annual Scientific Sessions of the American College of Cardiology (ACC) is one of the largest cardiology congresses and the 63rd Annual Scientific Sessions were held in Washington, DC, USA from 29 to 31 March 2014. There were approximately 19,000 registered attendees at this meeting. Founded in 1949, the ACC is a non-profit medical society that strives to improve healthcare delivery to patients with cardiovascular disease. The society comprises 50 chapters, one for each US state, and its 43,000 members are primarily cardiovascular healthcare professionals comprising generalist and specialist physicians, nurses, pharmacists and healthcare practice managers. The 63rd Annual Scientific Sessions showcased the results of 22 important clinical trials in five Late Breaking Clinical Trial sessions. Unlike previous meetings, where late-breaking trial presentations were followed by the presentation of a short commentary by a prominent expert, trial presentations at this meeting were followed by a short interactive session between the presenter and a panel of 6–8 experts on the dais (including the session Chair and Co-Chair). This report presents a brief summary of four late breaking clinical trials that are, in the opinion of this author, most likely to impact clinical practice.

Hotline update of clinical trials and registries presented at the American College of Cardiology Congress 2014

This article provides information and commentaries on trials which were presented at the Hotline and Clinical Trial Update Sessions during the Late Breaking Clinical Trial Sessions at the 63rd annual meeting of the American College of Cardiology in Washington, USA, from 29th to 31st March 2014. This article gives an overview on a number of novel clinical trials in the field of cardiovascular medicine, which were presented. Comprehensive summaries have been generated from the oral presentation and the webcasts of the American College of Cardiology, similar to as previously reported and should provide the readers with the most comprehensive information of relevant publications. The discussed studies are US CoreValve, Choice, Symplcity-HTN-3, GRS, ZEUS, GIPS-III, HEAT-PPCI, COPR-2, MSC-HF, POISE-2, SIRS. The data were presented by leading experts in the field.

Congress of European society of cardiology (amsterdam, 2013): new recommendations and most important clinical studies

In this review we present short report on European Congress of Cardiology which took place in Amsterdam from August 3 to September 4, 2013. Four new European recommendations on the treatment of cardiovascular diseases are briefly characterized and reports of Hot Line and Clinical Trial Update scientific sessions are presented.

Report of the American Heart Association (AHA) Scientific Sessions 2014, Chicago.

The American Heart Association (AHA) Scientific Sessions were held in Chicago on November 15-19, 2014. The meeting attracted more than 17,000 participants, including physicians, research scientists, students, and paramedical personnel, from more than 100 countries. Sessions over the 5 days included comprehensive and unparalleled education delivered via more than 5,000 presentations, with 1,000 invited faculty members and 4,000 abstract presentations from world leaders in cardiovascular (CV) disease. There were 16 trials scheduled in 4 late-breaking clinical trial sessions. The Dual Antiplatelet Therapy study revealed that aspirin plus a thienopyridine beyond 1 year subsequent to placement of a drug-eluting stent, as compared with aspirin therapy alone, significantly reduced stent thrombosis and major CV and cerebrovascular events but was associated with increased risk of bleeding. The IMPROVE-IT research showed that, relative to simvastatin with placebo, simvastatin with 10 mg of ezetimibe daily led to a significantly lower primary combined endpoint in moderate- to high-risk patients, who stabilized following acute coronary syndrome. This was the first trial to demonstrate incremental clinical benefit by adding a nonstatin agent to statin therapy and reaffirmed the low-density lipoprotein (LDL) hypothesis stating that reducing LDL-cholesterol prevents CV events. Summaries and overviews of both the late-breaking trials and the sessions to which members of the Japanese Circulation Society contributed are presented.

Inhibitory Effects of Eucommia ulmoides Oliv. Bark on Scopolamine-Induced Learning and Memory Deficits in Mice

Eucommia ulmoides Oliv. Bark (EUE) is commonly used for the treatment of hypertension, rheumatoid arthritis, lumbago, and ischialgia as well as to promote longevity. In this study, we tested the effects of EUE aqueous extract in graded doses to protect and enhance cognition in scopolamine-induced learning and memory impairments in mice. EUE significantly improved the impairment of short-term or working memory induced by scopolamine in the Y-maze and significantly reversed learning and memory deficits in mice as measured by the passive avoidance and Morris water maze tests. One day after the last trial session of the Morris water maze test (probe trial session), EUE dramatically increased the latency time in the target quadrant in a dose-dependent manner. Furthermore, EUE significantly inhibited acetylcholinesterase (AChE) and thiobarbituric acid reactive substance (TBARS) activities in the hippocampus and frontal cortex in a dose-dependent manner. EUE also markedly increased brain-derived neurotrophic factor (BDNF) and phosphorylation of cAMP element binding protein (CREB) in the hippocampus of scopolamine-induced mice. Based on these findings, we suggest that EUE may be useful for the treatment of cognitive deficits, and that the beneficial effects of EUE are mediated, in part, by cholinergic signaling enhancement and/or protection.

Reliability and discriminative power of soccer-specific field tests and skill index in young soccer players

Summary Purpose To examine the reliability and construct validity of straight sprint, agility, slalom dribble tests and skill index in young soccer players. Methods Ninety-two male soccer players (age: 14.2 ± 0.6 years; body mass: 54.0 ± 8.9 kg; height: 166.3 ± 9.4 cm; body mass index: 19.4 ± 1.7 kg/m 2 ) participated in this study. They were assigned to either two groups G1 or G2 according to their experience and competition levels. After familiarization, two trial sessions of three tests of sprint were administered: straight sprint (SS), agility test (AT) and slalom dribble test (SDT). Skill index (SI) was calculated as the ratio between AT and SDT. Results Reliability of SS, AT, SDT performances and SI were very good, with intraclass correlation coefficient greater than 0.80, CV less than 5%, low bias and small ratio limits of agreement. Areas under the receiver operating characteristics curves (ROC) were 0.555 (95% CI: 0.448–0.659), 0.851 (95% CI: 0.762–0.917), 0.913 (95% CI: 0.836–0.962) and 0.629 (95% CI: 0.522–0.727) for SS, AT, SDT and SI, respectively. Conclusions Results demonstrated that the three tests and SI were reliable but only AT, SDT and SI could discriminate between the levels of players’ ability. They could be used for soccer-specific skills assessments and selection process of young soccer players.

Sensory and cognitive influences on the training-related improvement of reading speed in peripheral vision

Reading speed in normal peripheral vision is slow but can be increased through training on a letter-recognition task. The aim of the present study is to investigate the sensory and cognitive factors responsible for this improvement. The visual span is hypothesized to be a sensory bottleneck limiting reading speed. Three sensory factors-letter acuity, crowding, and mislocations (errors in the spatial order of letters)-may limit the size of the visual span. Reading speed is also influenced by cognitive factors including the utilization of information from sentence context. We conducted a perceptual training experiment to investigate the roles of these factors. Training consisted of four daily sessions of trigram letter-recognition trials at 10° in the lower visual field. Subjects' visual-span profiles and reading speeds were measured in pre- and posttests. Effects of the three sensory factors were isolated through a decomposition analysis of the visual span profiles. The impact of sentence context was indexed by context gain, the ratio of reading speeds for ordered and unordered text. Following training, visual spans increased in size by 5.4 bits of information transmitted, and reading speeds increased by 45%. Training induced a substantial reduction in the magnitude of crowding (4.8 bits) and a smaller reduction for mislocations (0.7 bits), but no change in letter acuity or context gain. These results indicate that the basis of the training-related improvement in reading speed is a large reduction in the interfering effect of crowding and a small reduction of mislocation errors.

Developing a Manual for Strengthening Mental Health Nurses’ Clinical Supervision

In this article, we report findings from a study aimed at developing the content and implementation of a manual for a research-based intervention on clinical supervision of mental health nursing staff. The intervention was designed to strengthen already existing supervision practices through educational preparation for supervision and systematic reflection on supervision. The intervention consists of three sessions and was implemented on two groups of mental health hospital staff. We present an outline of the manual and explain how the trial sessions made us adjust the preliminary manual. The effects of implementing the manual will subsequently be analysed in an independent randomised controlled trial.

The INSPIRE International Lung Trial with the Organ Care System Technology (OCS™)

Purpose INSPIRE Trial is an international, FDA pivotal trial to assess the clinical efficacy and safety of OCS™ device to preserve, recruit and assess the donor lungs for transplantation as compared to current cold storage technique. Methods and Materials INSPIRE is a prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to Cold flush and storage (Control Group). A total of 264 primary lung transplant recipients will be randomized into the trial. Donor Inclusion Criteria: age Results Primary study endpoint is a composite of patient and graft survival at day 30 post transplantation, and incidence of ISHLT Primary Graft Dysfunction (PGD) Grade 3 at 72 hours post-transplantation. Secondary Endpoints: Incidence of ISHLT Primary Graft Dysfunction Grade 3 at 72 hours post-transplantation; Incidence of ISHLT Primary Graft Dysfunction Grade 2 or 3 at 72 hours post-transplantation; Patient survival at day 30; Graft survival at day 30. Other Endpoints: PGD score at T0, T24, and T48 hours; duration of invasive mechanical ventilation; length of post transplant ICU stay; length of post-transplant hospital stay; & additional hospital admission post initial discharge. Conclusions To-date 60 patients were transplanted in the trial. We will report the interim results at the late breaking clinical trial session at ISHLT 2013.

2-Phenylethynyl-butyltellurium attenuates amyloid-β peptide(25-35)-induced learning and memory impairments in mice

Our previous study demonstrated that 2-phenylethynyl-butyltellurium (PEBT), an organotellurium compound, enhances memory in mice. In this study, the effects of PEBT on cognitive impairment induced by Aβ25-35 were assessed by Morris water maze and step-down inhibitory avoidance tasks. Mice received a single intracerebroventricular injection of Aβ25-35 (3 nmol/3 μl/per site) and a daily oral administration of PEBT (1 mg/kg, for 10 days). PEBT significantly improved Aβ-induced learning deficits on the training session in the Morris water maze. At the probe trial session, PEBT significantly decreased the escape latency and increased the number of crossings in the platform local compared with the Aβ-treated group. PEBT significantly improved Aβ-induced memory impairment in the step-down inhibitory avoidance task. General locomotor activity was similar in all groups. This study showed that PEBT ameliorated the impairments of spatial and nonspatial long-term memory evaluated on Morris water maze and step-down inhibitory avoidance tasks, respectively. The results suggest that PEBT could be considered a candidate for the prevention of memory deficits such as those observed in Alzheimer's disease.

Ginsenosides Rg5 and Rh3 protect scopolamine-induced memory deficits in mice

Ethnopharmacological relevancePanax ginseng (family Araliaceae) is traditionally used as a remedy for cancer, inflammation, stress and aging. Aim of studyTo explore whether ginsenosides Rg5 and Rh3, the main constituents of heat-processed ginseng (the root of Panax ginseng), could protect memory deficit. Materials and methodsWe isolated ginsenosides Rh3 and Rg5 from heated-processed ginseng treated with and without human feces, respectively. Then we investigated their protective effects on memory impairment using the passive avoidance, Y-maze and Morris water maze tasks in mice. Memory deficit was induced in mice by the intraperitoneal injection of scopolamine. ResultsGinsenosides Rg5 or Rh3 increased the latency time reduced by scopolamine in passive avoidance test. Treatment with ginsenoside Rg5 or Rh3 significantly reversed the lowered spontaneous alteration induced by scopolamine in Y-maze task. Ginsenoisde Rg5 or Rh3 (10mg/kg) significantly shortened the escape latencies prolonged by treatment with scopolamine on the last day of training trial sessions in Morris water maze task. Furthermore, ginsenosides Rg5 and Rh3 inhibited acetylcholinesterase activity in a dose-dependent manner, with IC50 values of 18.4 and 10.2μM, respectively. The inhibitory potency of ginsenoside Rh3 is comparable with that of donepezil (IC50=9.9μM). These ginsenosides also reversed hippocampal brain-derived neurotrophic factor (BDNF) expression and cAMP response element-binding protein (CREB) phosphorylation reduced by scopolamine. Of them, ginsenoside Rh3 more potently protected memory deficit. ConclusionsGinsenoside Rg5 and its metabolite ginsenoside Rh3 may protect memory deficit by inhibiting AChE activity and increasing BDNF expression and CREB activation.

The Ameliorating Effect of Steamed and FermentedCodonopsis lanceolataon Scopolamine-Induced Memory Impairment in Mice

Codonopsis lanceolata (Campanulaceae) have been traditionally used to treat lung inflammatory diseases, such as asthma, tonsillitis, and pharyngitis. The present study was performed to evaluate the cognitive-enhancing effects of steamed and fermented C. lanceolata in scopolamine-induced memory impairments in mice. Cognitive abilities were determined by the Morris water maze and passive avoidance tests. Mice orally received fermented C. lanceolata extract at doses of 100, 300, or 500 mg/kg body weight. Fermented C. lanceolata extract (500 mg/kg body weight, p.o.) significantly shortened the escape latency times that were increased by scopolamine on the 4th day of trial sessions in the Morris water maze task. In addition, it exerted longer step-through latency times than those of the scopolamine-treated group in the passive avoidance test. Furthermore, the neuroprotective effects of fermented C. lanceolata extract on glutamate-induced neurocytotoxicity were investigated in HT22 cells. Fermented C. lanceolata extract showed a relative protection ratio of 59.62% at 500 μg/mL. In conclusion, fermented C. lanceolata extract ameliorated scopolamine-induced memory impairments, exerted neuroprotective effects, and improved activity compared to that found with original C. lanceolata. Further study will be required to investigate the mechanisms underlying this cognitive-enhancing activity.

Report of the American College of Cardiology (ACC) Scientific Sessions 2013, San Francisco

The American College of Cardiology's (ACC) 62nd Annual Scientific Session was held at the Moscone Center, San Francisco, from March 9-11, 2013. The meeting focused on the "transformation of cardiovascular care, from discovery to delivery", featured over 20 late-breaking clinical trials and 2,000 abstracts. These sessions gave notable exposure and recognition of studies likely to significantly affect clinical practice. There were 21 trials scheduled for presentation in 5 featured Late-Breaking Clinical Trial sessions, but one, the PREVAIL trial, was not presented because of a failure to observe an embargo. I summarize and overview both the late-breaking trials presented at ACC 2013 and the PREVAIL trial.

A report from the American Heart Association Scientific Sessions 2012 (November 3-7 - Los Angeles, California, USA)

Highly impacting oral and poster presentations wherein new treatment modalities for coronary artery disease, heart failure and other common cardiovascular diseases were presented throughout the AHA Scientific Sessions 2012, including new developments in the area of lipid-modifying therapies that starred one of the high-impact late-breaking clinical trial sessions during the conference. A summary of the most relevant findings among the over 4,000 abstracts presented during the meeting are reported in the following report.

Report of the American Heart Association (AHA) Scientific Sessions 2012, Los Angeles

The American Heart Association (AHA) Scientific Sessions were held for the first time in Los Angeles in 2012, with the most up-to-date basic and clinical science in the field presented and heard by physicians, research scientists, students, and paramedical personnel from 100 countries. Japan accounted for the second highest number of submitted abstracts and the Japanese Circulation Society actively contributed to the success of the AHA Scientific Sessions this year. The Late-Breaking Clinical Trial sessions comprised 27 clinical studies presented in the main hall. The FREEDOM study revealed the superiority of using a coronary artery bypass graft for diabetic multivessel coronary artery diseases over percutaneous coronary intervention using a drug-eluting stent. A new peptide hormone, serelaxin, improved dyspnea in heart failure patients and significantly reduced mortality rates according to the RELAX-AHF study. In the basic sciences, primary necrosis in mitochondria was the hot topic, while genetics, including genome-wide association studies, and epigenetics were strong features of the basic and clinical cardiovascular (CV) science. It was also clear that regenerative medicine is now part of mainstream CV research, with several clinical trials underway and many basic research projects ongoing around the world. Induced pluripotent stem cells in particular have the potential to change CV medicine, and will underpin the next era of regenerative medicine and personal therapies for heart diseases.

Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial

BackgroundHwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as ‘anger syndrome’. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety.Methods/designThe proposed study is a single-center, double-blind, randomized, controlled trial with two parallel arms: an oriental medicine music therapy (OMMT) group and a control music therapy (CMT) group. In total, 48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2), all participants fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the OMMT and the CMT (n = 24 each). Each group will receive treatment sessions over the course of 4 weeks, twice per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI), and the secondary outcomes are the Hwa-byung scale (H-scale), the Center for Epidemiologic Studies Depression Scale (CES-D), the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF), and levels of salivary cortisol. Patients will be asked to complete questionnaires at the baseline visit (visit 2), after the last treatment session (visit 9), and at 4 weeks after the end of all trial sessions (visit 10). From the baseline (visit 2) through the follow-up (visit 10), the entire process will take a total of 53 days.DiscussionThis proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in OMMT, patients actively move their bodies and play the music. Because Hwa-byung is caused by an accumulation of blocked emotions and anger inside the body, OMMT, because of its active component, is expected to be more efficacious than pre-existing music therapies.Trial registrationCurrent Controlled Trials ISRCTN11939282

Validation of Smart Garments for Physiological and Activity-Related Monitoring of Humans in Harsh Environment

A set of garments capable of monitoring the physiological, activity-related and environmental parameters of emergency operators during their interventions was developed in a European Project called ProeTEX. This work reports the results of the field trials performed with the final prototype release at the APT international Fire Fighting Survival Training Centre in Italy. Four sessions of trials (warm-up, rescue intervention, outdoor fire-fighting intervention and smoky chamber route) were performed in harsh environment by 6 professional Fire-Fighters. The operators wore the ProeTEX prototypes and their Heart Rate (HR), Breathing Rate (BR), Body Temperature (BT), External Temperature (ET), Heat Flux (HF) and GPS speed have been acquired. Percentage of samples out of the physiological range (R<SUP>%</SUP>) of the HR, BR and BT, as well as percentage of samples showing high variability (V<SUP>%</SUP>) of the HR, BR, BT, ET and HF have been processed. Percentage of GPS samples showing artefacts of their ground speed (S<SUP>%</SUP>) have been also computed. The results on the HR, BR and BT signals showed a maximum R<SUP>%</SUP> of 2.0, 7.8 and 8.5 respectively, as well as a maximum V<SUP>%</SUP> of 14.0, 10.0, 0.2, respectively. Concerning the ET and HH data, a V<SUP>%</SUP> lower than 0.0 and 2.9, respectively, was found. Finally, the highest detected value of S<SUP>%</SUP> of the GPS speed was 3.5 in all the trials. On the whole these results showed the efficacy of the ProeTEX wearable system and its capability of real-time and continuously monitoring the rescuers while they perform even highly intense activities in harsh environmental conditions.

S2‐03‐02: Using technology in designing clinical trials to investigate the efficacy of enhanced social engagement in MCI

Past epidemiological studies have demonstrated that larger social networks or more frequent social interactions could have potential protective effects on the incidence of AD. Psychological studies suggest that the task of conversation is highly cognitively stimulating: Conversations require attention, working memory and the organization and control of thought (executive functions), as well as social cognition to understand others' intentions and feelings. Despite the accumulating evidence that increasing social interaction could be a potentially promising intervention tool to improve cognitive and emotional well-being of the elderly, only a few randomized controlled prevention studies using social interaction have been conducted. We developed a randomized controlled behavioral clinical trial to examine whether conversation-based cognitive stimulation has a positive effect on general and domain-specific cognitive functions among older adults with normal cognition or mild cognitive impairment (MCI). Daily face-to-face communications are being conducted through the use of personal computers, webcams, and user-friendly interactive Internet conducted programs to allow participants to be more socially engage while staying at home. The trial protocol was developed forming an inter-disciplinary team of neurologists, neuropsychologists, social psychologists, linguistic scientists, engineers and statisticians. Pilot studies were conducted to develop user-friendly technology interfaces. A standardized conversational interview protocol was developed. Word counts spoken by the interviewer vs. participants during the trial session were monitored using an automated spoken language detection algorithm. A user-friendly Internet communication program using touch-screens and webcams was developed. To monitor daily conversations which might occur outside of the Internet-based conversations, algorithms for automatically extracting spoken language markers were developed, refined, and implemented into a wearable, voice activated digital recorder. To assess the generalizability of subsequent findings, we conducted mass mail-in surveys among community dwelling elderly, assessing demographic characteristics, life style factors and willingness of participating in trials which use technologies and the proposed prevention trial. The results obtained from this pilot study will be used for dose/duration determination in larger prevention studies that examine conversation-based cognitive stimulation as a potential intervention for cognitive decline and incident AD. The technology could improve the feasibility and cost-effective execution of social interaction based preventions.

Removal Time and Efficacy of Riddell Quick Release Face Guard Attachment System Side Clips During 1 Football Season

In the National Athletic Trainers' Association position statement, "Acute Management of the Cervical Spine-Injured Athlete," the technique recommended for face-mask (FM) removal is one that "creates the least head and neck motion, is performed most quickly, is the least difficult, and carries the least chance of failure." Industrial and technological advances in football helmet design and FM attachment systems might influence the efficacy of emergency FM removal. To examine the removal times and success rates of the Quick Release (QR) Face Guard Attachment System (Riddell Sports, Inc, Elyria, OH) throughout and at the conclusion of 1 season of play by a National Collegiate Athletic Association Division III football team competing in the Midwest. Controlled laboratory study. College laboratory. A total of 69 randomly selected Revolution IQ (Riddell Sports, Inc) football helmets fitted with the QR system were used. Each helmet was secured to a spine board, and investigators attempted to remove both of the QR side clips from the helmet with the Riddell insertion tool. Dependent variables included total time for removal of both QR side clips from the FM and success rate for removal of both side clips. The overall success rate for removal of both clips was 94.8% (164/173), whereas the mean times for removal of both clips ranged from 9.92 ± 12.06 seconds to 16.65 ± 20.97 seconds over 4 trial sessions. We found no differences among mean times for trial sessions throughout the season of play among the same helmets or among different helmets (P > .05). Removal time and success rate of the Riddell QR were satisfactory during and after 1 season of play despite use in various temperatures and precipitation.