26-week randomised parallel-group: Topics by WorldWideScience.org

Selegiline Transdermal System (STS) as an Aid for Smoking Cessation.

SummaryBackgroundInnovative prevention strategies for HIV-1 transmission are urgently needed. PRO2000 vaginal gel was efficacious against HIV-1 transmission in studies...Full Text Available

2010-10-16

The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: reanalysis of efficacy criteria.

INTRODUCTION: This study examined the efficacy and safety of selegiline transdermal system (STS) and brief repeated behavioral intervention (BRBI) for smoking cessation in heavy smokers. We hypothesized that the quit rate of subjects who received STS and BRBI would be significantly greater than that of those who received placebo patch and BRBI. METHODS: This was a double-blind, placebo-controlled parallel-group study in which 246 men and women were randomized to receive either STS (n = 121) or placebo patch (n =125) for 9 weeks. Recruitment targeted heavy smokers, defined as individuals with self-reported use of ?15 cigarettes/day in the 30 days prior to enrollment, who had smoked cigarettes for the past 5 years, and had an expired CO level ?9 ppm during screening. RESULTS: Although STS was well tolerated, the overall results indicated that STS with BRBI was not more effective than placebo plus BRBI for smoking cessation (p = .58). Conclusions: The results are ...

2011-08-16

Efficacy and safety of certolizumab pegol in an unselected crohn's disease population: 26-week data of the FACTS II survey

This is an independent reanalysis of a randomised, placebo-controlled parallel-group study on the efficacy and tolerability of a special butterbur root extract (Petadolex) for the prophylaxis of migraine. The original protocol and analysis had a number of major shortcomings. In order to follow regulatory requirements, an independent reanalysis of the original data was performed. Following a 4-week baseline phase, 33 patients were randomised to treatment with two capsules 25 mg butterbur twice a day and 27 to placebo. The mean attack frequency per month decreased from 3.4 at baseline to 1.8 after 3 months (p = 0.0024) in the verum group and from 2.9 to 2.6 in the placebo group (n.s.). The responder rate (improvement of migraine frequency > or =50%) was 45% in the verum group and 15% in the placebo group. Butterbur was well tolerated. This small trial indicates that butterbur may be effective in the prophylaxis of ...

2004-01-28

British Library Electronic Table of Contents (United Kingdom)

AbstractBackground: Certolizumab pegol (Cimzia, CZP) was approved for the treatment of Crohn's disease (CD) patients in 2007 in Switzerland as the first country worldwide. This prospective phase IV study aimed to evaluate the efficacy and safety of CZP over 26 weeks in a multicenter cohort of practice-based patients. Methods: Evaluation questionnaires at baseline, week 6, and week 26 were completed by gastroenterologists in hospitals and private practices. Adverse events were evaluated according to World Health Organization (WHO) guidelines. Results: Sixty patients (38F/22M) were included; 53% had complicated disease (stricturing or penetrating), 45% had undergone prior CD-related surgery. All patients had prior exposure to systemic steroids, 96% to immunomodulators, 73% to infliximab, and...

2011-01-01

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

Randomised Controlled Trial PFC Versus CKS Total Knee Prostheses

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,...Full Text Available

2007-01-01

A plantar flexion device exercise programme for patients with peripheral arterial disease: a randomised prospective feasibility study.

Osteoarthritis, Knee

2007-08-08

Cardiovascular Safety of Degarelix: Results From a 12-Month, Comparative, Randomized, Open Label, Parallel Group Phase III Trial in Patients With Prostate Cancer

PMID:21820543

2010-10-23

Is the operative delivery rate in low-risk women dependent on the level of birth care? A randomised controlled trial

PurposeWe assessed the cardiovascular safety profile of degarelix, a new gonadotropin-releasing hormone antagonist.Materials...Full Text Available

2010-12-01

Crotaline snake bite in the Ecuadorian Amazon: randomised double blind comparative trial of three South American polyspecific antivenoms

ObjectiveTo investigate possible differences in operative delivery rate among low-risk women, randomised to an alongside midwifery-led unit or to standard obstetric units within...Full Text Available

2011-10-01

Comparison of a minimally invasive procedure versus standard microscopic discotomy: a prospective randomised controlled clinical trial

Objective To compare the efficacy and safety of three polyspecific antivenoms for bites by pit vipers.Design Randomised double blind comparative trial of three antivenoms.Setting...Full Text Available

2004-11-13

Short-term inhibition of ADP-induced platelet aggregation by clopidogrel ameliorates radiation-induced toxicity in rat small intestine.

A Prospective randomised controlled study was done to determine statistical difference between the standard microsurgical discotomy (MC) and a minimally invasive microscopic procedure for disc prolapse...Full Text Available

2009-07-01

Mediation of bone ingrowth in porous hydroxyapatite bone graft substitutes.

Endothelial dysfunction and increased platelet aggregation may be involved in the pathogenesis of normal tissue radiation toxicity. This study assessed clopidogrel, an inhibitor of ADP-induced platelet aggregation, as a modulator of intestinal radiation injury (radiation enteropathy). Rat small intestine was exposed to 21 Gy X-radiation. Clopidogrel (20 mg/kg/day) or vehicle was administered from 2 days before to 10 days after irradiation. Structural radiation injury, neutrophil infiltration, smooth muscle cell proliferation, collagen content, and TGF-beta1 expression were assessed 2 weeks (early phase) and 26 weeks (delayed phase) after irradiation, using quantitative histology and immunohistochemistry, morphometry, and real-time fluorogenic probe RT-PCR. Irradiated intestine exhibited significant histopathologic injury, reduced mucosal surface area, vascular sclerosis, intestinal wall fibrosis, increased collagen content, and increased ...

2002-01-01

Low birthweight infants and total parenteral nutrition immediately after birth. II. Randomised study of biochemical tolerance of intravenous glucose, amino acids, and lipid.

Previous investigations have shown that both the early biological response and the mechanical properties of a porous hydroxyapatite bone graft substitute are highly sensitive to its pore structure. The objective of this study was to evaluate whether the pore structure continued to influence bone integration in the medium to long term. Two screened batches of porous hydroxyapatite (PHA) designated as batch A and batch B, with porosities of approximately 60 and 80%, respectively, were selected for this study and implanted for periods of 5, 13, and 26 weeks into the lower femur of New Zealand White rabbits. Histomorphometric analysis of the absolute volume of bone ingrowth within batch A and B implants from 5 to 26 weeks showed that the absolute volume of bone ingrowth was consistently lower in batch A (10-21%), compared to batch B implants (24-31%). However, when the volume of bone ingrowth was normalised ...

2004-01-01

Laparoscopic examination of the reproductive organs in women treated for infertility; Laparoskopowa ocena narzadow plciowych u kobiet leczonych z powodu nieplodnosci

This randomised study aimed to compare the biochemical tolerance of three parenteral regimens administered during the first 48 hours of life. Twenty nine infants were randomised to either: (a) glucose...Full Text Available

1995-07-01

Adalimumab treatment in Crohn's disease does not induce early changes in regulatory T cells

The authors discuss 84 cases of laparoscopic examination of women with primary or secondary infertility. The patients qualified for this examination had undergone at least 26 weeks of conventional treatment with no effect. In 7 cases the reproductive organ was found to be in order, with fallopian tubes fully patent. In 43 cases tubar inpatency was found (using hysterosalpingographic examination). The remaining patients suffered from other reproductive organ disorders. Therefore, the laparoscopic examination made detailed recognition of the causes of infertility possible and thus helped to establish the proper treatment. Additionally, in some cases it enabled the immediate removal of the source of infertility. (author)

1993-12-31

British Library Electronic Table of Contents (United Kingdom)

Abstract Objective. Anti-TNF-a antibodies has been suggested to modulate regulatory T cell (Treg) percentages in rheumatoid arthritis, but results from studies of Crohn's disease (CD) are conflicting. We investigated dynamic changes of circulating Tregs in CD during treatment with the anti-TNF-a-antibody adalimumab (Humira, Abbott Laboratories A/S, Emdrupvej 28C, DK-2100 Copenhagen). Material and methods. Blood samples from 26 CD patients were analysed using flow cytometry before and 1 and 26 weeks after initiation of adalimumab treatment to determine the percentage of Tregs among CD4++ T cells. Results. In spite of a significant decline in disease activity scores and biochemical markers of inflammation, during the first week of treatment, we did not observe early modulating effects of ada...

2011-01-01

Randomised, placebo-controlled trial to evaluate co-trimoxazole to reduce mortality and morbidity in HIV-infected post-natal women in Zambia (TOPAZ)

PMID:20417857

2010-04-24

British Library Electronic Table of Contents (United Kingdom)

Summary Objective- To evaluate the role of prophylactic trimethoprim-sulfamethoxazole (co-trimoxazole) antibacterial prophylaxis in reducing morbidity and mortality in HIV-infected post-natal women in southern Africa. Methods- Double-blind placebo-controlled trial. HIV-infected women with WHO stage 2 or 3 HIV disease who had recently delivered in the Department of Obstetrics and Gynaecology at the University Teaching Hospital, Lusaka, Zambia were randomised to receive daily co-trimoxazole (cotox) or matched placebo daily for the duration of the trial. Participants were followed up for a minimum of 1-year. Primary outcome measures were mortality from any cause or hospital admission and serious adverse events. Results- Of 600 women randomised, follow-up information was available from 355 (18...

2011-01-01

Post-operative hilotherapy in SMAS-based facelift surgery: A prospective, randomised, controlled trial

British Library Electronic Table of Contents (United Kingdom)

Background: Ecchymosis, oedema, haematoma and pain after SMAS-based facelift surgery are all the direct result of the physical trauma of surgery and subsequent inflammatory response. Hilotherapy is a novel form of cryotherapy that purports to minimise these events through single-use face masks circulating cooled, sterile water. This study was performed to assess the validity of Hilotherapy in this population of patients. Methods: Over 14 weeks fifty consecutive patients were randomised to post-operative facial cooling with Hilotherapy or management with standard dressings alone, while fifteen subsequent, consecutive patients were randomised to cooling of one side of the face but not the other. Assessment of ecchymosis, oedema, haematoma and pain was performed independently by clinical staf...

2011-01-01

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Chloroquine for influenza prevention: a randomised, double-blind, placebo controlled trial

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Background: Chloroquine has in-vitro activity against influenza and could be an ideal candidate for worldwide prevention of influenza in the period between onset of a pandemic with a virulent influenza strain and the development and widespread dissemination of an effective vaccine. We aimed to assess the efficacy of such an intervention. Methods: In this randomised, double-blind, placebo-controlled trial done at a single centre in Singapore, we randomly assigned (1:1) healthy adults to receive chloroquine phosphate (500 mg/day for 1 week, then once a week to complete 12 weeks) or matching placebo by use of a computer-generated randomisation list. Participants filled an online symptom diary every week, supplemented by daily diaries and self-administered nasal swabs when unwell. Haemagglutin...

2011-01-01

Trial of early nifedipine in acute myocardial infarction: the Trent study.

The Effects on Saturated Fat Purchases of Providing Internet Shoppers with Purchase- Specific Dietary Advice: A Randomised Trial

Over 30 months 9292 consecutive patients admitted to nine coronary care units with suspected myocardial infarction were considered for admission to a randomised double blind study comparing the effect...Full Text Available

1986-11-08

The CORONIS Trial. International study of caesarean section surgical techniques: a randomised fractional, factorial trial

Objectives:The supermarket industry now services many customers through online food shopping over the Internet. The Internet shopping process offers a novel opportunity...Full Text Available

Shoulder adhesive capsulitis: systematic review of randomised trials using multiple corticosteroid injections

BackgroundCaesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years – about 20–25% in...Full Text Available

Self-management of fatigue in rheumatoid arthritis: a randomised controlled trial of group cognitive-behavioural therapy

BackgroundAdhesive capsulitis is a common, painful, and disabling condition that has been managed with corticosteroid injections for over 50 years. There is debate over the use of...Full Text Available

2007-08-01

Reduction in blood pressure with a low sodium, high potassium, high magnesium salt in older subjects with mild to moderate hypertension.

ObjectivesTo investigate the effect of group cognitive behavioural therapy (CBT) for fatigue self-management, compared with groups receiving fatigue information alone, on fatigue...Full Text Available

Randomised trial of telephone intervention in chronic heart failure: DIAL trial

OBJECTIVE--To examine the effect of a reduced sodium and increased potassium and magnesium intake on blood pressure. DESIGN--Randomised double blind placebo controlled trial. SETTING--General population...Full Text Available

1994-08-13

Randomised controlled trial of disclosure of emotionally important events in somatisation in primary care

Objective To determine whether a centralised telephone intervention reduces the incidence of death or admission for worsening heart failure in outpatients with chronic heart failure.Design...Full Text Available

2005-08-20

No Effect of a Homeopathic Preparation on Neonatal Calf Diarrhoea in a Randomised Double-Blind, Placebo-Controlled Clinical Trial

ObjectiveTo test whether a disclosure intervention improves subjective health and reduces medical consumption and sick leave in somatising patients in general practice.DesignNon-blind...Full Text Available

2001-07-14

Low dose subcutaneous adrenaline to prevent acute adverse reactions to antivenom serum in people bitten by snakes: randomised, placebo controlled trial

A double-blind, placebo-controlled clinical trial of a homeopathic treatment of neonatal calf diarrhoea was performed using 44 calves in 12 dairy herds. Calves with spontaneously derived diarrhoea were...Full Text Available

2003-01-01

Long-term impact of acyclovir suppressive therapy on genital and plasma HIV RNA in Tanzanian women: a randomised controlled trial

ObjectiveTo assess the efficacy and safety of low dose adrenaline injected subcutaneously to prevent acute adverse reactions to polyspecific antivenom serum in patients admitted...Full Text Available

1999-04-17

Enhancing return-to-work in cancer patients, development of an intervention and design of a randomised controlled trial

BackgroundHerpes simplex virus (HSV) suppressive therapy reduces genital and plasma HIV-1 RNA over periods up to three months but the longer-term effect is unknown.Full Text Available

2010-05-01

Efficacy and cost-effectiveness of a physiotherapy program for chronic rotator cuff pathology: A protocol for a randomised, double-blind, placebo-controlled trial

BackgroundCompared to healthy controls, cancer patients have a higher risk of unemployment, which has negative social and economic impacts on the patients and on society at large....Full Text Available

Effects of calcium supplementation on bone density in healthy children: meta-analysis of randomised controlled trials

BackgroundChronic rotator cuff pathology (CRCP) is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there...Full Text Available

Effect of lowering blood pressure on cardiovascular events and mortality in patients on dialysis: a systematic review and meta-analysis of randomised controlled trials

Objectives To assess the effectiveness of calcium supplementation for improving bone mineral density in healthy children and to determine if any effect is modified by other factors and...Full Text Available

2006-10-14

Comparison of injection techniques for shoulder pain: results of a double blind, randomised study.

SummaryBackgroundPatients undergoing dialysis have a substantially increased risk of cardiovascular mortality and morbidity. Although several trials have shown the...Full Text Available

2009-03-21

Chronic lymphatic leukaemia and engine exhausts, fresh wood, and DDT: a case-referent study.

Seventy seven patients with soft tissue shoulder lesions including adhesive capsulitis and disorders of the rotator cuff and acromioclavicular joint were admitted to a trial comparing two different...Full Text Available

1983-11-05

Bereavement help-seeking following an 'expected' death: a cross-sectional randomised face-to-face population survey

The effect of potential risk factors for chronic lymphatic leukaemia was evaluated in a case-referent study encompassing 111 cases and 431 randomised referents, all alive. Information on exposure was...Full Text Available

1988-01-01

A randomised clinical trial of intrapartum fetal monitoring with computer analysis and alerts versus previously available monitoring

BackgroundThis study examines the prevalence and nature of bereavement help-seeking among the population who experienced an "expected" death in the five years before their survey...Full Text Available

A prospective randomised study on the long-term effect of lumbar fusion on adjacent disc degeneration

BackgroundIntrapartum fetal hypoxia remains an important cause of death and permanent handicap and in a significant proportion of cases there is evidence of suboptimal care related...Full Text Available

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A novel school-based intervention to improve nutrition knowledge in children: cluster randomised controlled trial

The existence and importance of an accelerated adjacent segment disc degeneration (ASD) after lumbar fusion have previously not been demonstrated by RCTs. The objectives of this study were, to determine...Full Text Available

2009-08-01

A Randomised Placebo-Controlled Trial of a Traditional Chinese Herbal Formula in the Treatment of Primary Dysmenorrhoea

BackgroundImproving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a...Full Text Available

A Prospective, Randomised, Controlled Trial Comparing Wound Dressings Used in Hip and Knee Surgery: Aquacel and Tegaderm Versus Cutiplast

BackgroundMost traditional Chinese herbal formulas consist of at least four herbs. Four-Agents-Decoction (Si Wu Tang) is a documented eight hundred year old formula containing four...Full Text Available

Oral intake of purple passion fruit peel extract reduces pain and stiffness and improves physical function in adult patients with knee osteoarthritis

INTRODUCTIONCutiplast (absorbent perforated dressing with adhesive border; Smith & Nephew) is commonly used following orthopaedic operation, but complications of its use...Full Text Available

2006-01-01

British Library Electronic Table of Contents (United Kingdom)

Knee osteoarthritis (OA) is a common degenerative joint disorder and a major cause of pain and disability. The hypothesis tested in this study was that the passion fruit peel extract (PFP), a flavonoid-rich dietary supplement, would reduce symptoms due to knee OA. Thirty-three OA patients were enrolled in a randomized, double-blind, placebo-controlled trial with parallel-group design. Patients received either placebo or PFP pills (150 mg, daily) in a double-blinded fashion for 2 months. The OA clinical symptoms were evaluated monthly with Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index. In the PFP group, there was a significant improvement in total WOMAC score and WOMAC subscale score of physical function after 30 days and pain after 60 days. At 60 days, reductions o...

2010-01-01

Iopentol in cardioangiography

Efficiency study of different photovoltaic plant connection schemes under dynamic shading

Iopentol (350 mg I/ml) has been compared with iohixol (350 mg I/ml) in a double-blind randomized parallel group trial with 32 and 35 patients receiving iopentol and iohexol, respectively. Coronary angiography and left ventriculography were performed, and the mean total volume injected was 124 ml of iopentol and 135 ml of iohexol . There were no statistically significant differences regarding changes in heart rate and frequency of adverse advents, which were the primary parameters, between the two groups of patients. Blood pressure and ECG parameters revealed only minor fluctuations which were of no clinical relevance. The visualization of the coronary arteries and the left ventricle were the same with both contrast media, as was the diagnostic quality. The results support the use of iopentol in cardioangiography. (author). 1 ref.; 5 tabs.

Diagnostic quality in hysterosalpingography

An important growth in the power of the photovoltaic systems connected to a grid has recently been observed. In spite of the advances in module technology, the problems in the system design increased, especially regarding the surface of the earth they occupy. In this work we propose a complete model for plant simulation with different wiring diagrams and under dynamic shading. Results obtained from simulations showed that the configuration with the lowest performance was that of only one serial-parallel group, whereas the highest efficiency corresponded to a design of groups of modules in parallel connected then in series. In general, a higher efficiency was obtained diminishing the quantity of modules in series and increasing their number in parallel. The simulation model proposed allows exploring different alternatives of wiring modules and finding the most efficient configurations for photovoltaic plants of medium and high power. (author)

2010-06-15

The management of wounds following primary lower limb arthroplasty: a prospective, randomised study comparing hydrofibre and central pad dressings

Purpose: To compare the diagnostic quality and adverse events of the water-soluble, non-ionic, iso-osmolar, dimeric contrast media iodixanol and iotrolan in hysterosalpingography (HSG). Material and Methods: One hundred and twenty patients participated in a double-blind randomized parallel-group phase-III study. Questionnaires and patient interviews were used. Diagnostic quality was assessed using a visual analogue scale and the quality in specific regions was rated using a categorical scale. Results: Overall diagnostic quality was equal for the two groups. There was no statistically significant difference between the two groups in diagnostic quality in the specific regions of interest. No differences between the contrast media were found with regard to adverse events. Conclusion: Both contrast media provided images of high diagnostic quality in HSG. (orig.)

1998-11-01

British Library Electronic Table of Contents (United Kingdom)

Abuzakuk T, Coward P, Shenava Y, Kumar VS, Skinner JA. The management of wounds following primary lower limb arthroplasty: a prospective, randomised study comparing hydrofibre and central pad dressings. Abstract Wound care following lower limb arthroplasty has not been subject to in-depth clinical research, primarily because such wounds usually heal without complication. However, when prosthetic implants are used, serious wound problems can be disastrous (Whitehouse et al. Infect Control Hosp Epidemiol 2002;23:183-9; Lindwell OM. Clin Orthop Relat Res 1986;211:91-103). We report the results of a prospective, randomised, controlled trial comparing a hydrofibre (Aquacel) and central pad (Mepore) dressing in the management of acute wounds following primary total hip or knee arthroplasty left ...

2006-01-01

Cost-effectiveness of educational outreach to primary care nurses to increase tuberculosis case detection and improve respiratory care: economic evaluation alongside a randomised trial

British Library Electronic Table of Contents (United Kingdom)

Summary Objective To evaluate the cost-effectiveness of an educational outreach intervention to improve primary respiratory care by South African nurses. Methods Cost-effectiveness analysis alongside a pragmatic cluster randomised controlled trial, with individual patient data. The intervention, the Practical Approach to Lung Health in South Africa (PALSA), comprised educational outreach based on syndromic clinical practice guidelines for tuberculosis, asthma, chronic obstructive pulmonary disease, pneumonia and other respiratory diseases. The study included 1999 patients aged 15 or over with cough or difficult breathing, attending 40 primary care clinics staffed by nurses in the Free State province. They were interviewed at first presentation, and 1856 (93%) were interviewed 3 months late...

2010-01-01

Adalimumab sustains steroid-free remission after 3-years of therapy for Crohn-s disease

British Library Electronic Table of Contents (United Kingdom)

Summary Background- Treatments that achieve sustainable steroid-free clinical remission in Crohn-s disease are needed; however, long-term steroid-sparing efficacy data are limited. Aim- To evaluate steroid-sparing efficacy and the impact of steroid discontinuation on adverse events during treatment of Crohn's disease with adalimumab in the phase III randomised, double-blind 1-year CHARM trial and for an additional 2-years in its open-label extension ADHERE. Methods- Steroid-free remission and response and steroid-sparing (-50% steroid dose reduction) remission rates were evaluated over 3-years in patients who were taking corticosteroids at CHARM baseline. Results- Of 778 patients randomised in CHARM (including those who did not achieve clinical response to open-label induction therapy), 31...

2011-01-01

Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

Support and Assessment for Fall Emergency Referrals (SAFER 1) trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial

BackgroundDue to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments...Full Text Available

Patterns of soil-transmitted helminth infection and impact of four-monthly albendazole treatments in preschool children from semi-urban communities in Nigeria: a double-blind placebo-controlled randomised trial

BackgroundMany emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital...Full Text Available

Methods for economic evaluation of a factorial-design cluster randomised controlled trial of a nutrition supplement and an exercise programme among healthy older people living in Santiago, Chile: the CENEX study

BackgroundChildren aged between one and five years are particularly vulnerable to disease caused by soil-transmitted helminths (STH). Periodic deworming has been shown to improve...Full Text Available

Efficacy of a heat inactivated hepatitis B vaccine in male homosexuals: outcome of a placebo controlled double blind trial.

BackgroundIn an effort to promote healthy ageing and preserve health and function, the government of Chile has formulated a package of actions into the Programme for Complementary...Full Text Available

A comparison of the acute haemodynamic effects of nisoldipine and nifedipine during treatment with atenolol in patients with coronary artery disease.

The efficacy of a heat inactivated hepatitis B virus vaccine, containing 3 micrograms hepatitis B surface antigen (HBsAg), was studied in a high risk group of 800 susceptible homosexual men by a randomised...Full Text Available

1983-04-23

Iodixanol in cerebral computed tomography: a randomized, double-blind, phase-III, parallel study with iodixanol and iohexol

1. The acute haemodynamic effects of intravenous nisoldipine (1, 2, 4 microg kg(-1)) and nifedipine (2.5, 5, 10 microg kg(-1)) were compared in a randomised, within-patient crossover study. Fifteen...Full Text Available

1993-10-01

Injection-associated pain in femoral arteriography: A European multicenter study comparing safety, tolerability, and efficacy of iodixanol and iopromide

Iodixanol is a new nonionic dimer, isotonic with blood at all clinically relevant concentrations. Iodixanol (270 mg I/ml) was compared in a double-blind, randomized, parallel-group, phase-III study to the monomeric nonionic iohexol (300 mg I/ml) for evaluation of safety, tolerability and radiographic efficacy during cerebral CT. One hundred adult patients scheduled to undergo contrast-enhanced cerebral CT were randomly allocated to receive either iodixanol or iohexol. All completed the trial. Safety was evaluated by recording discomfort and other adverse events, tolerance by assessing intensity and incidence of discomfort. Radiographic efficacy was assessed from the diagnostic information and the radiographic density. No serious adverse events occurred. One patient (2 %) in the iodixanol group and one patient (2 %) in the iohexol group experienced a transient reddening at the neck and lower neck-line, respectively. Both contrast agents were well tolerated. One ...

1999-09-01

A randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of nebivolol, a novel beta-blocker, in patients with mild to moderate hypertension.

Purpose. To evaluate injection-associated pain, safety, and efficacy with the isotonic contrast medium iodixanol (Visipaque 270 mg I/ml) compared with iopromide (Ultravist 300 mg I/ml) in femoral arteriography. Methods. A multicenter, double-blind, randomized, parallel-group clinical investigation was carried out in 54 hospitals in Europe. Of the patients evaluated, 1225 received iodixanol and 1227 iopromide in conventional and/or digital subtraction angiography. Results. The iodixanol group reported statistically significantly less injection-associated pain (0.9%) than the iopromide group (9.5%) (p<0.001). Further, 4.1% in the iodixanol group experienced pain and/or severe heat sensation vs 19.8% in the iopromide group (p<0.001). In the iodixanol group, 1.8% of the patients experienced contrast-related adverse events vs 2.4% in the iopromide group (p=NS). Overall diagnostic information was optimal for 94.1% in the iodixanol group and 95.3% in the iopromide ...

1997-07-01

The management of wounds following primary lower limb arthroplasty: a prospective, randomised study comparing hydrofibre and central pad dressings

This double-blind, multicenter, randomized placebo-controlled study evaluated the antihypertensive efficacy and safety of nebivolol, a selective beta1-adrenoreceptor blocker with vasodilating effects, in patients with mild to moderate hypertension (sitting diastolic blood pressure [SiDBP] > or =95 mm Hg and < or =109 mm Hg). A total of 909 patients were randomized to receive placebo or nebivolol 1.25, 2.5, 5, 10, 20, or 40 mg once daily for up to 84 days. The primary end point was the change in trough SiDBP from baseline to study end. Nebivolol significantly reduced trough SiDBP (8.0-11.2 mm Hg compared with 2.9 mm Hg with placebo; P<.001) and trough sitting systolic blood pressure (a 4.4-9.5-mm Hg decrease compared with a 2.2-mm Hg increase [corrected] with placebo; P< or =.002). The overall adverse event experience was similar in the nebivolol (46.1%) and placebo (40.7%) groups (P=.273). Once-daily nebivolol is an effective antihypertensive in mild to moderate ...

2007-09-01

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British Library Electronic Table of Contents (United Kingdom)

Abuzakuk T, Coward P, Shenava Y, Kumar VS, Skinner JA. The management of wounds following primary lower limb arthroplasty: a prospective, randomised study comparing hydrofibre and central pad dressings. Pris en charge des plaies apres arthroplastie primaire du member inferieur: une etude randomisee prospective comparant hydrofibre et pansements central pad La prise en charge des plaies apres arthroplastie du member inferieur n'a pas fait l'objet de recherches approfondies, essentiellement car ces plaies cicatrisent habituellement sans complications. Cependant, lorsque des implants prothetiques sont utilizes, les serieux problemes de plaies peuvent devenir desastreux. Nous rapportons les resultants d'une etude prospective, randomisee, controlee comparant un hydrofibre et un pasnement centra...

2006-01-01

Multicentre, randomised, controlled study of the impact of continuous sub-cutaneous glucose monitoring (GlucoDay) on glycaemic control in type 1 and type 2 diabetes patients

British Library Electronic Table of Contents (United Kingdom)

ResumeObjectif determiner dans une etude randomisee l'impact d'un enregistrement continu du glucose sous-cutane pendant 48 heures sur le controle glycemique trois mois plus tard chez des patients presentant un diabete de type 1 (DT1) ou de type 2 (DT2). Methodes Quarante-huit patients avec un mauvais equilibre glycemique (HbA1c : 8-10,5 %) ont beneficie d'un enregistrement continu du glucose sous-cutane pendant 48 heures avec le systeme GlucoDay (A. Menarini Diagnostics) et ont ete randomises en deux groupes : ajustement de traitement en fonction de l'autosurveillance glycemique capillaire (groupe ASG) ou du profil d'enregistrement continu du glucose sous-cutane (groupe CGM). Le dosage d'HbA1c et le port du GlucoDay ont ete renouveles trois mois plus tard. Resultats Trente-quatre patients ...

2009-01-01

An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial

British Library Electronic Table of Contents (United Kingdom)

Summary Background Treatment of localised renal cell carcinoma consists of partial or radical nephrectomy. A substantial proportion of patients are at risk for recurrence because no effective adjuvant therapy exists. We investigated the use of an autologous, tumour-derived heat-shock protein (glycoprotein 96)-peptide complex (HSPPC-96; vitespen) as adjuvant treatment in patients at high risk of recurrence after resection of locally advanced renal cell carcinoma. Methods In this open-label trial, patients were randomly assigned to receive either vitespen (n=409) or observation alone (n=409) after nephrectomy. Randomisation was done in a one to one ratio by a computer-generated pseudo-random number generator, with a block size of four, and was stratified by performance score, lymph node stat...

2008-01-01

Cellular Sources of Transforming Growth Factor-? Isoforms in Early and Chronic Radiation Enteropathy

Conservative treatment options for carpal tunnel syndrome: a systematic review of randomised controlled trials.

The three mammalian transforming growth factor (TGF)-? isoforms (TGF-?1, TGF-?2, and TGF-?3) differ in their putative roles in radiation-induced fibrosis in intestine and other organs. Furthermore, tissue specificity of TGF-? action may result from temporal or spatial changes in production and/or activation. The present study examined shifts in the cell types expressing TGF-? mRNA relative to TGF-? immunoreactivity and histopathological injury during radiation enteropathy development. A 4-cm loop of rat small intestine was locally exposed to 0, 12, or 21-Gy single doses of x-irradiation. Sham-irradiated and irradiated intestine were procured 2 and 26 weeks after irradiation. Cells expressing the TGF-?1, TGF-?2, or TGF-?3 transcripts were identified by in situ hybridization with digoxigenin-labeled riboprobes. Intestinal wall TGF-? immunoreactivity was measured using computerized image analysis, and structural radiation injury was assessed by ...

1998-11-01

The role of insulin therapy and glucose normalisation in patients with acute coronary syndrome

Carpal tunnel syndrome (CTS) is a common disorder, for which various conservative treatment options are available. The objective of this study is to determine the efficacy of the various conservative treatment options for relieving the symptoms of CTS. Computer-aided searches of MEDLINE (1/1966 to 3/2000), EMBASE (1/1988 to 2/2000) and the Cochrane Controlled Trials Register (2000, issue 1) were conducted, together with reference checking. Included were randomised controlled trials evaluating the efficacy of conservative treatment options in a study population of CTS patients, with a full report published in English, German, French or Dutch. Two reviewers independently selected the studies. Fourteen randomised controlled trials were included in the review. Assessment of methodological quality and data-extraction was independently performed by two reviewers. A rating system, based on the number of studies and their methodological quality and ...

2002-03-01

British Library Electronic Table of Contents (United Kingdom)

Patients with acute myocardial infarction (AMI) and diabetes mellitus, as well as patients admitted with elevated blood glucose without known diabetes, have impaired outcome. Therefore intensive glucose-lowering therapy with insulin (IGL) has been proposed in diabetic or hyperglycaemic patients and has been shown to improve survival and reduce incidence of adverse events. The current manuscript provides an overview of randomised controlled trials investigating the effect of IGL. Furthermore, systematic glucose?insulin?potassium infusion (GIK) has been studied to improve outcome after AMI. In spite of positive findings in some early studies, GIK did not show any beneficial effects in recent clinical trials and thus this concept has been abandoned. While IGL targeted to achieve normoglycaemi...

2011-01-01

Penile rehabilitation therapy following radical prostatectomy

British Library Electronic Table of Contents (United Kingdom)

Purpose. To compare erectile function (EF) recovery of patients treated by early penile rehabilitation therapy (PRT) with sildenafil and with control group. Method. Forty men treated by bilateral nerve sparing radical prostatectomy (NSRP) and with a normal pre-operative EF were enrolled. Fourteen days after surgery, they were randomised to a flexible-dose sildenafil group and to a control group. The International Index of Erectile Function (IIEF) questionnaire was completed before surgery and at 3, 6, 12 and 24 weeks after NSRP. Results. In the group treated, the mean IIEF score before surgery was 26.2 and 14.1, 16.2, 22.5 and 25.2 at 3, 6, 12 and 24 weeks after NSRP, respectively. In the control group, the respective scores were 26.5 and 12.4, 15.8, 15.3 and 17.4. There was a significant ...

2010-01-01

Cochrane Review: Polysaccharide vaccines for preventing serogroup A meningococcal meningitis

British Library Electronic Table of Contents (United Kingdom)

AbstractBackground Randomised controlled trials (RCTs) in the 1970s and early 1980s showed the polysaccharide serogroup A vaccine (SgAV) prevented serogroup A meningococcal meningitis (SGAMM). Subsequent non-RCTs suggested significant variations in the age-specific duration of protection among children. Objectives To determine the protective effect, duration of protection, age-specific effects and the effect of booster doses in children of the SgAV against SGAMM. Search strategy We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, issue 2) which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE (January 1950 to May Week 3, 2010) and EMBASE (January 1974 to May 2010). Selection criteria We included RCTs. Non-RCTs ...

2011-01-01

A prospective randomised open label study to evaluate the potential of a new silver alginate/carboxymethylcellulose antimicrobial wound dressing to promote wound healing

British Library Electronic Table of Contents (United Kingdom)

The aim of this study was to observe both the clinical signs and symptoms of wounds at risk of infection, that is critically colonised (biofilm infected) and antimicrobial-performance of an ionic silver alginate/carboxymethylcellulose (SACMC) dressing, in comparison with a non silver calcium alginate fibre (AF) dressing, on chronic venous leg and pressure ulcers. Thirty-six patients with venous or pressure ulcers, considered clinically to be critically colonised (biofilm infected), were randomly chosen to receive either an SACMC dressing or a non silver calcium AF dressing. The efficacy of each wound dressing was evaluated over a 4-week period. The primary study endpoints were prevention of infection and progression to wound healing. The SACMC group showed a statistically significant (P = ...

2010-01-01

Pioglitazone does not affect vascular or inflammatory responses after endotoxemia in humans.

Long-term antidyskinetic efficacy of amantadine in Parkinson's disease.

PPARgamma agonists have been proposed to exert more than metabolic benefits, particularly by anti-inflammatory mechanisms. We hypothesized that pioglitazone might modulate inflammatory and vascular responses to lipopolysaccharide (LPS). In a placebo-controlled parallel-group study in 18 healthy male subjects, the E. coli endotoxin model of inflammation (20 IU/kg i. v.) was employed to test the effect of 60 mg pioglitazone over nine days on inflammatory cytokines. Macrovascular function and microvascular blood flow were assessed by brachial artery ultrasound and retinal blood flow parameters, respectively. Pioglitazone increased brachial artery diameter by 5.6% but had no effect on other outcome parameters under resting conditions. LPS increased cytokine levels to peak concentrations of 91.3+/-22.5 ng/ml (IL-6), 261.4+/-60.0 ng/ml (TNFalpha), and 524.5+/-15.3 ng/ml (VCAM-1). The endotoxin caused microvascular vasodilation and increased retinal white blood cell flux, ...

2008-05-21

Iodixanol in cerebral computed tomography: a randomized, double-blind, phase-III, parallel study with iodixanol and iohexol

Several randomized placebo-controlled trials have consistently shown antidyskinetic effects of amantadine in levodopa treated patients with advanced Parkinson's disease (PD). However, all of these were of short duration and there have been claims that the effect of amantadine on levodopa induced dyskinesias (LID's) wear off after about 9 months of treatment. This randomized placebo-controlled parallel-group study was performed to assess the long-term antidyskinetic effect of amantadine in 32 PD patients, who after having been on stable amantadine therapy for LID over at least one year- were switched in a double blind manner to amantadine or placebo and followed for 3 weeks. Dyskinesia duration and intensity were assessed by UPDRS IV items 32 and 33 as well as by patient's diaries. The primary outcome was the score change of UPDRS IV items 32 + 33 between baseline and 3 weeks after treatment as well as the between treatment group comparison of the score change of ...

2010-07-30

Effects of felbamate on the pharmacokinetics of a low-dose combination oral contraceptive.

1999-09-01

Effect of inhaled beclomethasone dipropionate on isocapnic hyperventilation with cold air in asthmatics, measured with forced oscillation technique.

The effects of felbamate on the pharmacokinetics of a low-dose combination oral contraceptive containing 30 micrograms ethinyl estradiol and 75 micrograms gestodene were assessed in a randomized, double-blind, placebo-controlled parallel-group study in healthy premenopausal female volunteers established in a regimen of oral contraceptive use. They received either placebo or 2400 mg/day felbamate from midcycle (day 15) to midcycle (day 14) of two consecutive oral contraceptive cycles (months 1 and 2). Pharmacokinetic assessments of ethinyl estradiol and gestodene were performed on day 14 of both cycles. To determine whether ovulation occurred, plasma progesterone and urinary luteinizing hormone levels were measured, and diaries recording vaginal bleeding were kept. Felbamate treatment resulted in a significant 42% decrease in gestodene area under the plasma concentration-time curve (0 to 24 hours) (p = 0.018) compared with baseline, whereas a minor but not ...

1995-11-01

Comparison of gadobenate dimeglumine (Gd-BOPTA) with gadopentetate dimeglumine (Gd-DTPA) for enhanced MR imaging of brain and spine tumours in children

Isocapnic hyperventilation with cold air (IHCA) is a reliable technique for assessing indirect bronchial hyperresponsiveness in patients with asthma. Impedance measurement of the respiratory system by the forced pseudorandom noise oscillation technique is a sensitive technique to assess changes in bronchial tone after IHCA. The aim of this study was to evaluate the effect of 6 weeks of treatment with beclomethasone dipropionate, 1,000 microg x day-1, on IHCA in asthmatic patients, measured with both forced oscillation technique and flow-volume recordings. Forty patients with mild asthma were included in this double-blind, placebo-controlled parallel-group study. Stratification on the basis of sex was performed to overcome differences in airway diameter. At entry and every 2 weeks during the treatment period, IHCA was performed and patient diaries were evaluated. Characteristic changes in forced oscillation parameters after IHCA were observed in all patients. After ...

1997-03-01

Adiponectin concentrations increase during acute FFA elevation in humans treated with rosiglitazone.

Sixty-three subjects, aged 6 months to 16 years, who were enrolled in a prospective, fully blinded, randomized parallel-group phase III clinical trial, received 0.1 mmol/kg doses of either Gd-BOPTA (n=29) or Gd-DTPA (n=34). The MR images were acquired before and within 10 min of contrast agent injection. The primary objective was to compare the difference from pre-dose to post-dose lesion visualization between Gd-BOPTA and Gd-DTPA. Lesion visualization was determined as the sum of individual scores for three criteria of lesion morphological characteristics (lesion border delineation, internal morphology, and contrast enhancement), each assessed qualitatively using 4-point scales. Quantitative evaluation compared changes in lesion-to-background (LBR) and contrast-to-noise (CNR) ratios and per cent enhancement. Monitoring for adverse events and evaluation of vital signs and laboratory values was performed. Pre-dose to post-dose changes in lesion visualization were ...

2005-05-01

A randomised controlled trial of intervention site radiotherapy in malignant pleural mesothelioma

The adipocytokine adiponectin is released by adipocytes upon activation of the peroxisome proliferator-activated receptor gamma (PPAR gamma). PPAR gamma has binding sites for thiazolidinediones and free fatty acids (FFAs). To evaluate if adiponectin serum concentrations are synergistically regulated by FFAs and thiazolidinediones IN VIVO plasma FFAs were acutely elevated in healthy subjects pre-treated with rosiglitazone or placebo. Sixteen healthy male subjects (23-37 years) were included in this double-blind, randomized, placebo-controlled parallel-group study. Rosiglitazone 8 mg or placebo was administered daily for 21 days. On the last day plasma FFA concentrations were increased by an intravenous triglyceride/heparin infusion. Blood for determination of adiponectin, C-reactive protein (CRP), leptin, resistin, FFAs, glucose, and insulin was drawn at baseline and on day 21 before and after 5 hours of triglyceride/heparin infusion. Adiponectin concentrations ...

2007-10-01

A prospective randomised open label study to evaluate the potential of a new silver alginate/carboxymethylcellulose antimicrobial wound dressing to promote wound healing.

Background and purpose: To assess the effectiveness of radiotherapy in preventing tumour seeding after chest drain or pleural biopsy in patients with malignant mesothelioma and to determine, if tract metastases appear, whether they are tender or troublesome to patients. Patients and methods: Patients with a histological diagnosis of pleural mesothelioma and an invasive procedure within the preceding 21 days were stratified by age, performance status and treatment centre. Randomisation was performed between immediate drain site radiotherapy 21 Gy in three fractions (XRT arm) or best supportive care (BSC) with follow-up to 12 months. Patients were asked to complete questionnaires on treatment toxicity and on symptoms from any tract metastases detected. Results: Sixty-one patients were recruited from two centres between 1998 and 2004; 56 men, 5 women, median age 70. 31 were allocated to drain site radiotherapy. Seven patients developed tract metastases associated with ...

2007-07-01

Prevention of panic attacks and panic disorder in COPD.

2010-05-31

Incredible Years Parent Training Support for Nursery Staff Working within a Disadvantaged Flying Start Area in Wales: A Feasibility Study

This study examined whether cognitive behavioural therapy (CBT) could prevent the development or worsening of panic-spectrum psychopathology and anxiety symptoms in chronic obstructive pulmonary disease (COPD). 41 patients with COPD, who had undergone pulmonary rehabilitation, were randomised to either a four-session CBT intervention condition (n = 21) or a routine care condition (n = 20). Assessments were at baseline, post-intervention, and at 6-, 12- and 18-month follow-ups. Primary outcomes were the rates of panic attacks, panic disorder and anxiety symptoms. Secondary outcomes were depressive symptoms, catastrophic cognitions about breathing difficulties, disease-specific quality of life and hospital admission rates. There were no significant differences between the groups on outcome measures at baseline. By the 18-month follow-up assessment, 12 (60%) routine care group participants had experienced at least one panic attack in the previous 6 months, with two ...

2009-09-09

Combining iodine-131 Lipiodol therapy with low-dose cisplatin as a radiosensitiser: preliminary results in hepatocellular carcinoma

Parenting programmes are effective interventions for preventing and treating conduct problems in young children. Up to 20% of children in disadvantaged areas have conduct disorder. Recent government initiatives such as targeting early years services to designated disadvantaged Flying Start areas in Wales have resulted in increased nursery-care provision for pre-schoolers, yet little has been done to equip nursery staff with effective child behaviour management strategies. The purpose of this non-randomised trial platform study was to establish the feasibility of delivery and the effectiveness of the new Incredible Years Toddler Parent Programme in supporting nursery staff in managing difficult behaviour in the nursery. The Parent Programme is a 12-session (a two-hour session/week) course for carers/parents of children aged one to three years old, which encourages carers to: establish positive relationships with children through play and child-centred activities; ...

2010-12-01

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CT colonography: optimisation, diagnostic performance and patient acceptability of reduced-laxative regimens using barium-based faecal tagging

A prospective pilot trial was performed in 20 patients randomised to receive either {sup 131}I-Lipiodol therapy alone (n=10) or {sup 131}I-Lipiodol combined with a short low-dose cisplatin infusion (n=10), the aim being to evaluate the possible positive influence of a radiosensitiser on toxicity and tumour response. An activity of 1,354-2,128 MBq (mean 1,824 MBq) [36.6-57.5 mCi (mean 49.3 mCi)] {sup 131}I-labelled Lipiodol was administered by selective instillation in the hepatic artery. Cisplatin was given in a dose of 30 mg/m{sup 2} at day -1 and day +6 (day 0: {sup 131}I-Lipiodol). The primary endpoint of this trial was toxicity of therapy; points of secondary interest were tumour response and survival at 6 months. With the use of cisplatin we found a higher percentage of stable or diminished tumour size (90%, vs 40% without). A benefit in group survival at 6 months was not evident. Low-grade stomatitis in one patient and minor changes in peripheral blood count ...

2002-07-01