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Trial Involving (trial + involving)
Selected AbstractsTrials update in walesCYTOPATHOLOGY, Issue 2007A. Fiander Three ongoing studies will be presented and discussed. Prevalence of Human Papillomavirus Infection in a South Wales Screening population Methods: A total of 10 000 consecutive, anonymous liquid based cytology screening samples were collected over a five month period in 2004. Age, cytology result and social deprivation score was provided for each specimen. The methodology was chosen to ensure inclusion of all women attending routine cervical screening, avoiding potential constraints associated with obtaining individual informed consent. The liquid based cytology samples were processed and reported by the receiving cytology laboratory and the residual specimens sent to the HPV Research Laboratory, Wales College of Medicine, where they were processed and stored at -80°C until analysis. High risk and low risk HPV Typing was undertaken using PCR , EIA (Jacobs et al 1997). Full high risk typing was performed on HPV positive specimens. Results: The study population had a mean age of 38 years with 92% negative, 5% borderline and 3% dyskaryotic cytology. The average social deprivation score was 17.4 (based upon the Welsh Index of multiple deprivation). The following results will be presented: HPV prevalence by age. HPV prevalence by cytology result. Type specific HPV prevalence in single and multiple infection. Conclusion: This study represents the largest type specific HPV Prevalence Study in the UK to date. As such it will form a useful base line against which to access performance of marketed HPV tests and evaluating the impact following implementation of HPV vaccination. [Funded by Welsh Office for Research and Development] CRISP , 1 Study (Cervical Randomized Intervention Study Protocol -1) Background: Indole-3-carbinol (I3C) and Diindolylmethane (DIM) are found in cruciferous vegetables and have been identified as compounds that could potentially prevent or halt carcinogenesis. I3C spontaneously forms DIM in vivo during acid digestion. I3C has been shown to prevent the development of cervical cancer in HPV 16 transgenic mice and both I3C and DIM have been shown to promote cell death in cervical cancer cell models. DIM is the major active bi-product of I3C and preliminary data indicate that DIM is active in cervical dysplasia and may be better tolerated than I3C. Aim: To investigate chemoprevention of high grade cervical neoplasia using Diindolylmethane (DIM) supplementation in women with low grade cytological abnormalities on cervical cytology. Objectives: To observe any reduction in the prevalence of histological proven high-grade cervical intraepithelial neoplasia (CIN) after 6 months of supplementation. ,,To observe any reduction in the prevalence of cytological abnormalities. ,,To observe any changes in the clinical appearance of the cervix. To assess acceptability and monitor any side effects of DIM supplementation. ,,To assess whether any benefit is seen in relation to Human Papillomavirus (HPV) status including HPV Type, Viral load and integration. Methods: This is a double blind randomized placebo-controlled trial involving 600,700 women with low grade cytological abnormalities on a cervical smear. Randomization is in the ratio of 2 : 1 in favour of active medication. Women with first mildly dyskaryotic smear or second borderline smear are eligible. They are asked to take two capsules daily for 6 months. At the end of 6 months they undergo repeat cervical cytology, HPV testing and colposcopy. Results: A progress report will be given for this ongoing study. [Funded: - Cancer Research UK] Type Specific HPV Infection in Welsh Cervical Cancers Background: Whilst there have been numerous studies of HPV infection associated with cervical cancer and on prevalence of Human Papillomavirus in diverse populations there have been no studies of these variables in the same population. Against a background of prophylactic HPV vaccination it is important to assess potential protection against cervical cancer within a given population. The most comprehensive analysis of HPV type specific cervical cancer is a meta-analysis published by the IARC in 2003. This however included only three UK based studies, totalling 118 cases, 75 of which were only investigated by HPV type PCR for four high risk types. None of this data was presented with associated population based prevalence data. Therefore, the research objectives for this study in combination with the first study above, are as follows: To determine the frequency of specific HPV types in cervical cancers in Wales. To compare the distribution of specific HPV types amongst cervical cancers with their prevalence in the general population. This will allow accurate delineation of the relationship between prevalence of specific HPV types in the general population and their association with clinically relevant disease. This information is a pre-requisite to assess the potential impact of prophylactic vaccination against HPV infection in Wales. Methods: Welsh Cervical Cancer specimens from 2000,2005 will be identified from pathology departments within Wales. The pathology of each tumour will be reviewed by a single Gynaecological Pathologist. The age of the patient and pathological features of the tumour will be noted. DNA will be extracted from the paraffin sections and HPV typed by PCR-EIA. Results: A progress report will be given for this ongoing study. [Funded by Welsh Office for Research and Development] [source] Comparison of efficacy of pantoprazole alone versus pantoprazole plus mosapride in therapy of gastroesophageal reflux disease: a randomized trialDISEASES OF THE ESOPHAGUS, Issue 4 2004K. Madan SUMMARY, The present study aimed to compare the efficacy for the therapy of GERD of pantoprazole alone with a combination of pantoprazole and mosapride. The study was a prospective, randomized trial involving 68 patients suffering heartburn and/or regurgitation at least twice a week for 6 weeks. Sixty-one patients consented to be randomized to receive either pantoprazole 40 mg b.i.d. (n = 33, group A) or pantoprazole 40 mg b.i.d. plus mosapride 5 mg t.d.s. (n = 28, group B) for 8 weeks. Twenty-four-hour esophageal pH-metry and endoscopy were conducted at recruitment and endoscopy was repeated at 8 weeks in all the patients studied. There were no differences in symptomatic responses to therapy between the groups (69.7% vs 89.2%; P = 0.11). The mean symptom score after 8 weeks was significantly lower in group B (3.78 ± 3.62 vs 1.67 ± 2.09; P = 0.009). Nonerosive esophagitis was present in 29 patients. In patients with nonerosive GERD there was no significant difference in symptomatic response to either regimen (17/20 in group A and 7/9 in group B responded; P = 0.63). In erosive esophagitis, symptomatic responses occurred more frequently in group B, 18/19 (94.7%), than in group A, 6/13 (46.2%; P = 0.003). However endoscopic healing of esophagitis occurred equally with either regimen (6/11, 54.5% in group A; 12/17, 70.5% in group B; P = 0.44). In nonerosive GERD, the addition of mosapride offers no benefit over pantoprazole alone. A combination of pantoprazole and mosapride is more effective than pantoprazole alone in providing symptomatic relief to patients with erosive GERD. [source] The efficacy of dantrolene sodium in controlling exertional rhabdomyolysis in the Thoroughbred racehorseEQUINE VETERINARY JOURNAL, Issue 7 2003J. G. T. Edwards Summary Reasons for performing study: Dantrolene sodium (Dantrium) has been used extensively for the treatment of myopathies in man and anecdotal evidence suggests it is of clinical benefit in the control of exercise-induced rhabdomyolysis (ER) in racehorses, although data to support this are currently lacking. Objectives: To investigate the efficacy of oral dantrolene sodium in controlling ER in a randomised, double-blind, placebo-controlled crossover trial involving 77 Thoroughbred racehorses in Newmarket, UK. Methods: Horses were treated on 2 occasions 1 week apart, with treatment days coinciding with a return to exercise following 2 days box rest on each occasion. For the first treatment, each horse was randomly selected to receive either 800 mg dantrolene sodium or a colour- matched placebo administered orally 1 h before exercise. This was followed by crossover to the other treatment on the second occasion, with each horse thereby acting as its own control. Degree of ER was assessed using rising serum creatine kinase (CK) levels, by subtracting pre-exercise blood CK levels from those measured in 6 h post exercise blood samples. For each horse, the difference in change between pre- and post exercise CK values between placebo and dantrolene treatments was calculated, with positive values indicating a greater rise with placebo than with dantrolene sodium treatment. Results: The overall mean difference for all horses was +104.8 iu/l and the null hypothesis, that there was no true difference in non-normally distributed post exercise rises in CK values between placebo and dantrolene treatments, was rejected (P = 0.0013) using the nonparametric Wilcoxon signed rank test. Additionally, no horses given dantrolene sodium showed clinical signs of ER, whereas 3 horses given the placebo developed ER following exercise. The incidence of ER in the study was 4% (3/77). Conclusions: The results confirmed that oral administration of dantrolene sodium, 1 h before exercise, had a statistically significant effect on reducing the difference between pre - and post exercise plasma CK levels compared with a placebo in the same animals, and preventing clinical ER in susceptible individuals. Potential relevance: This study suggested that dantrolene sodium is of use in controlling ER in the Thoroughbred racehorse. Further investigation into pre- and post exercise myoplasmic calcium levels and the repeat of the study late in the season when horses receive a much higher energy ration and more strenuous exercise would appear to be warranted. [source] Long-term control of mycosis fungoides of the hands with topical bexaroteneINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 3 2003Ted Lain BA Background Limited Stage IA mycosis fungoides (MF) is often treated with topical steroids, which can cause atrophy, or with nitrogen mustard, which imposes several limitations on the patient's lifestyle. Topical bexarotene is a novel synthetic rexinoid with few side-effects that has shown efficacy for treatment of mycosis fungoides skin lesions in recent Phase II,III clinical trials. The Phase I,II trial involving 67 stage IA,IIA MF patients demonstrated complete response (CR) in 21% and partial response (PR) in 42% of the patients. The median time to response was approximately 20 weeks. In the phase III trial of refractory stage IA, IB and IIA MF, the patients demonstrated a 44% response rate (8% CR). Patients with no prior therapy for mycosis fungoides responded at a higher rate (75%) than those with prior topical therapies. Methods Case report of a patient with MF limited to the hands treated with topical bexarotene 0.1% gel in a open label phase II clinical trial. Results Partial response occurred after 2 weeks of topical bexarotene therapy and the lesions were well controlled for 5 years using bexarotene monotherapy, with only occasional mild local irritation. Conclusions Topical bexarotene is effective as long-term treatment monotherapy for limited MF lesions. To our knowledge this is the longest use of the drug by any individual. [source] Effectiveness of brief structured interventions on risk factor modification for patients with coronary heart disease: a systematic reviewINTERNATIONAL JOURNAL OF EVIDENCE BASED HEALTHCARE, Issue 4 2007Ritin Fernandez RN MN (Critical care) PhD Candidate Abstract Background, The physical and psychosocial benefits of participation in cardiac rehabilitation following a coronary event have well been established. Despite these benefits there is strong evidence that participation in traditional cardiac rehabilitation programs remains low. Various models of cardiac rehabilitation have been implemented including the use of brief structured interventions to enable modification of coronary risk factors. Objectives, The objective of this review was to determine the effect of brief structured interventions on risk factor modification in patients with coronary heart disease. Search strategy, A literature search was performed using the following databases MEDLINE (1966,2006), CINAHL (1982,2006), EMBASE (1980,current) and up to the Cochrane Controlled Trials Register (Issue 2, 2006 of Cochrane Library). In addition, the reference lists of relevant trials and conference proceedings were also scrutinised. Company representatives, experts and investigators were contacted to elicit further information. Selection criteria, All randomised and quasi-randomised controlled trials that compared the effects of brief structured interventions on risk factor modification in patients with coronary heart disease were considered for inclusion in the review. Data collection and analysis, Eligibility of the trials for inclusion in the review, details of eligible trials and the methodological quality of the trials were assessed independently by two reviewers. Relative risks for dichotomous data and a weighted mean difference for continuous data were calculated with 95% confidence intervals. Where synthesis was inappropriate, trials were considered separately. Main results, Seventeen trials involving a total of 4725 participants were included in the final review: three trials compared the effects of brief structured interventions on diet modification; seven on smoking cessation; and seven on multiple risk factors. Two trials involving 76 patients compared brief structured intervention versus usual care for dietary modification. Although there was a tendency for more participants in the intervention arm to lose weight at the 12-week follow up and achieve target cholesterol levels at the 6-month follow up, these results were not statistically significant. Only one small trial involving 36 patients compared brief structured intervention and extensive intervention for dietary modification and demonstrated a significant reduction in the percentage of energy obtained from fat and saturated fat intake among participants receiving extensive intervention. However, no difference in fish, fruit and vegetable intake between the groups was evident. Six trials involving 2020 patients compared brief structured intervention versus usual care for smoking cessation. There was no difference in the smoking cessation rates at the 3- and 6-week follow up, however, there was evidence of a benefit of brief structured interventions for smoking cessation at the 3-, 6- and 12-month follow up. In the only trial that and compared brief structured intervention and extensive intervention for smoking cessation in 254 participants there was no clear difference of a likelihood of smoking cessation between the two groups. In the seven trials that compared brief structured intervention and usual care for multiple risk factor modification there was evidence of a benefit of the intervention on behavioural changes such as fat intake, weight loss and consequently on reduction in the body mass index, smoking cessation and physical activity among the participants. The findings concerning the effect on blood pressure, blood glucose levels and the lipid profile, however, remain inconclusive. Conclusions, There is suggestive but inconclusive evidence from the trials of a benefit in the use of brief interventions for risk factor modification in patients with coronary heart disease. This review, however, supports the concept that brief interventions for patients with coronary heart disease can have beneficial effects on risk factor modification and consequently on progression of coronary heart disease. Further trials using larger sample sizes need to be undertaken to demonstrate the benefits of brief structured intervention targeted at the modification of single or multiple risk factors. [source] International validation of a health-related quality of life questionnaire in patients with erosive gastro-oesophageal reflux diseaseALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2009G. HOLTMANN Summary Background, Although erosive gastro-oesophageal reflux disease (GERD) is a highly prevalent condition, there is no specific, valid, reliable and sensitive questionnaire that allows evaluating treatment-induced changes in health-related quality of life (HRQoL). Aim, To design a self-administered questionnaire, the GERD Analyzer (GERDyzer), for use in clinical studies. Methods, The GERDyzer comprises 10 dimensions each illustrated by pictogram-like drawings, simplifying communication with the patients. Self-assessment is performed by 100 mm Visual Analogue Scales. For validation, a 5-week clinical trial involving 395 patients (per-protocol) with oesophagitis was conducted. Patients were treated with pantoprazole (40 mg o.d.) for 28 days. Psychometric analyses included internal consistency, test,retest reliability, responsiveness and construct validity. Results, Factor analysis showed consistency of the dimensions and no reduction was necessary. Validation of GERDyzer indicated high internal consistency (Cronbach's , = 0.95) and test,retest reliability (intraclass correlation coefficient =0.91). Responsiveness of the total score expressed by nonparametric effect size was 1.38. Comparison of scores with other questionnaires resulted in logical correlation levels depending on the respected concepts measured. Conclusions, GERDyzer proved to be highly valid, reproducible and responsive. It allows reliably assessing treatment-induced changes in HRQoL in erosive GERD. [source] Efficacy of Enalapril for Prevention of Congestive Heart Failure in Dogs with Myxomatous Valve Disease and Asymptomatic Mitral RegurgitationJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 1 2002Clarence Kvart We evaluated the long-term effect of early angiotensin-converting enzyme (ACE) inhibition (enalapril maleate) as monotherapy to postpone or prevent congestive heart failure (CHF) in asymptomatic dogs with mitral regurgitation (MR) attributable to myxomatous valvular disease (MVD) in a prospective, randomized, double-blinded, placebo-controlled multicenter trial involving 14 centers in Scandinavia. Two hundred twenty-nine Cavalier King Charles (CKC) Spaniels with MR attributable to MVD but no signs of CHF were randomly allocated to treatment with enalapril 0.25,0.5 mg daily (n = 116) or to placebo groups (n = 113). Each dog was evaluated by physical examination, electrocardiography, and thoracic radiography at entry and every 12 months (±30 days). The number of dogs developing heart failure was similar in the treatment and placebo groups (n = 50 [43%] and n = 48 [42%], respectively; P= .99). The estimated means, adjusted for censored observations, for the period from initiation of therapy to heart failure were 1,150 ± 50 days for dogs in the treatment group and 1,130 ± 50 days for dogs in the placebo group (P= .85). When absence or presence of cardiomegaly at the entrance of the trial was considered, there were still no differences between the treatment and placebo groups (P= .98 and .51, respectively). Multivariate analysis showed that enalapril had no significant effect on the time from initiation of therapy to heart failure (P= .86). Long-term treatment with enalapril in asymptomatic dogs with MVD and MR did not delay the onset of heart failure regardless of whether or not cardiomegaly was present at initiation of the study. [source] Trial of nurse-run asthma clinics based in general practice versus usual medical careRESPIROLOGY, Issue 3 2004Louis S. PILOTTO Objective: The aim of this study was to assess the ability of nurse-run asthma clinics based in general practice compared with usual medical care to produce at least a moderate improvement in the quality of life of adults with asthma. Methodology: A randomized controlled trial involving 80 asthma clinic and 90 usual medical care asthma participants, aged 18 years and older was conducted in 11 general practices in Adelaide. The main outcome measure was the St George's respiratory questionnaire (SGRQ), from which quality-of-life scores were used to assess therapeutic benefit. Lung function measurements and health services utilization data were also collected. Results: One hundred and fifty-three participants (90%) were reviewed at follow up after 6,9 months. There was little difference between groups in baseline measures or for the 6-month follow-up, outcomes,, including, the, mean, difference, in, total, SGRQ, scores, (,0.5,, 95%, confidence, interval, (CI) ,4.0, 2.9) and the mean difference in percentage predicted FEV1 (2.3%, 95% CI ,0.7, 5.3 pre-bronchodilator; 0.4%, 95% CI ,5.1, 5.9 post-bronchodilator). Trends in health services utilization were noted. Conclusions: Nurse-run asthma clinics based in general practice and usual medical care were similar in their effects on quality of life and lung function in adults. These findings cannot be generalized to hospital outpatients and other clinics that manage more severe asthmatic patients. [source] Randomised comparison of Pentax AirwayScope and Glidescope for tracheal intubation in patients with normal airway anatomyANAESTHESIA, Issue 10 2009W. H. L. Teoh Summary We compared intubating characteristics of the Pentax AirwayScope and Glidescope in a randomised controlled trial involving 140 patients. We found significantly shorter intubation times with mean (SD) 21.3 (12.3) vs 30.2 (13.2) s, lower intubating difficulty scores 4.4 (10.4) vs 12.8 (16.3) p < 0.001, and better grade 1 laryngeal views with the Pentax AirwayScope (95.7 vs 81.4%, p = 0.015). Significantly more optimisation manoeuvres were needed to successfully intubate with the Glidescope, with significant inability to align the tip of the tracheal tube with the glottic opening with the Glidescope in 9 (13%) vs no patients, p = 0.013. There was more mucosal bleeding (4 (5.7%) vs 1 (1.4%), p = 0.366), more lip bleeding (3 (4.3%) vs 1 (1.4%), p = 0.620) and significantly more postoperative sorethroat, 13 (18.6%) vs 0, p < 0.001 associated with the Glidescope. [source] Nutrient utilization and manure P excretion in growing pigs fed corn-barley-soybean based diets supplemented with microbial phytaseANIMAL SCIENCE JOURNAL, Issue 1 2009Adewale EMIOLA ABSTRACT The effect of high levels of microbial phytase supplementation in diets for growing pigs was studied in a 2-week performance and nutrient digestibility trial involving 28 growing pigs weighing 16.4 ± 1.06 (mean ± SD) kg. Seven corn-barley-soybean meal-based diets consisting of a positive control (PC) formulated to meet or exceed NRC nutrient requirements; a negative control (NC) with non-phytate P reduced by 0.1% unit from NRC requirement and fed without or with 500 or 1000 U/kg; a doubled negative control (DNC) with no added inorganic P and fed without or with 2000 or 4000 U/kg. Chromic oxide was added as an indigestible marker and all diets were fed as mash. Pigs fed the PC diet had a higher P digestibility compared with those fed the NC (P < 0.02) and the DNC (P < 0.001) diets. Supplementing the NC diet with pyhtase tended to improve P digestibility (P < 0.10). However, addition of phytase to the DNC diet resulted in linear (P < 0.001) and quadratic (P < 0.03) increases in P digestibility with an overall improvement of 8% and 121% at 4000 phytase U/kg of diet, respectively, compared with the PC and DNC diets. Apparent total tract digestibility of N, OM and DM were higher (P < 0.05) in the PC diet compared with the DNC diet, but not the NC diet (P < 0.10). No effect of phytase addition to NC was observed on Ca, N, DM and OM digestibility. Phytase addition to the DNC diet resulted in a linear increase (P < 0.05) in N, DM and OM digestibility but not Ca. Increasing the levels of phytase supplementation in the NC and the DNC diets linearly decreased fecal P (P < 0.05) content by 45 and 42%, respectively. Adding phytase at 1000 or 4000 U/kg increased P retention (P < 0.05) by 14.3 or 15.6% units, respectively, compared with the PC diet. Urinary P excretion was higher in the group fed the PC diet compared with those fed the NC and DNC diets (P < 0.05). The results of this study show that complete removal of inorganic P from growing pig diets coupled with phytase supplementation improves digestibility and retention of P and N, thus reducing manure P excretion without any negative effect on pig performance. [source] Expert testimony in recovered memory trials: Effects on mock jurors' opinions, deliberations and verdictsAPPLIED COGNITIVE PSYCHOLOGY, Issue 4 2010Julie A. Buck The current study examined the impact of adversarial expert testimony on deliberations and verdicts in a mock trial involving recovered memories of child sexual abuse. Participants (N,=,238) were randomly assigned to one of the six conditions in a 2 (Defense Expert: absent or present),×,3 (Plaintiff Expert: absent, general or specific/therapist) factorial design. After reading the mock trial transcript, participants completed a questionnaire and deliberated to reach a jury verdict. The defense expert's statements effectively reduced the number of pro-plaintiff verdicts and the plaintiff's credibility. These effects were not mitigated by the plaintiff experts, suggesting that the plaintiff experts may only confirm jurors' prior pro-repression beliefs. Copyright © 2009 John Wiley & Sons, Ltd. [source] Efficacy of methotrexate treatment in patients with probable rheumatoid arthritis: A double-blind, randomized, placebo-controlled trialARTHRITIS & RHEUMATISM, Issue 5 2007Henrike van Dongen Objective To determine whether patients with undifferentiated arthritis (UA; inflammatory, nontraumatic arthritis that cannot be diagnosed using current classification criteria) benefit from treatment with methotrexate (MTX). Methods The PRObable rheumatoid arthritis: Methotrexate versus Placebo Treatment (PROMPT) study was a double-blind, placebo-controlled, randomized, multicenter trial involving 110 patients with UA who fulfilled the American College of Rheumatology (ACR) 1958 criteria for probable RA. Treatment started with MTX (15 mg/week) or placebo tablets, and every 3 months the dosage was increased if the Disease Activity Score was >2.4. After 12 months, the study medication was tapered and discontinued. Patients were followed up for 30 months. When a patient fulfilled the ACR criteria for RA (primary end point), the study medication was changed to MTX. Joint damage was scored on radiographs of the hands and feet. Results In 22 of the 55 patients (40%) in the MTX group, UA progressed to RA compared with 29 of 55 patients (53%) in the placebo group. However, in the MTX group, patients fulfilled the ACR criteria for RA at a later time point than in the placebo group (P = 0.04), and fewer patients showed radiographic progression over 18 months (P = 0.046). Conclusion This study provides evidence for the efficacy of MTX treatment in postponing the diagnosis of RA, as defined by the ACR 1987 criteria, and retarding radiographic joint damage in UA patients. [source] | ||||||||||