... 3 randomized clinical trials, and 1 open-label prospective study ... non-immune travellers to Sub-Saharan Africa: multicentre, randomised, double ...

Objectives To examine the effectiveness of cytological surveillance in primary care compared with immediate referral for colposcopic examination in women with low grade abnormal results on cervical cytology tests.Design Multicentre individually randomised controlled trial.Setting NHS cervical screening programmes in Grampian, Tayside, ...

Objectives To compare the effectiveness of punch biopsy and selective recall for treatment versus a policy of immediate treatment by large loop excision in the management of women with low grade abnormal cervical cytology referred for colposcopy.Design Multicentre individually randomised controlled trial, nested within the NHS cervical ...

BackgroundPregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted. These babies are at high risk of milk intolerance and necrotising enterocolitis, as well as post-natal growth failure, and there is no clinical consensus about how best to feed them. Policies of both early milk ...

flow. However, these effects have not been established in a large randomised controlled trial, and use of dopamine remains controversial. We have done a multicentre, randomised, double-blind, placebo assigned a continuous intravenous infusion of low-dose dopamine (2 g kg 1 min 1 ) or placebo administered

BackgroundA hypoxic-ischaemic insult occurring around the time of birth may result in an encephalopathic state characterised by the need for resuscitation at birth, neurological depression, seizures and electroencephalographic abnormalities. There is an increasing risk of death or neurodevelopmental abnormalities with more severe encephalopathy. Current ...

The SEAS study is a prospective national, multicentre, multidisciplinary, cohort study in which the cardiac abnormalities following aneurysmal subarachnoid haemorrhage are studied. Incidence, clinical implications and predictive variables of cardiac abnormalities following aneurysmal subarachnoid haemorrhage will be studied. Cardiac ...

BackgroundChildhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a ...

PURPOSE: In a register study, the risk of anastomotic leakage correlated to the choice of circular stapling device with a 4% difference between the two brands used. Based on those data, a randomised multicentre study was started to explore the risk of an anastomotic leakage based upon the surgical device. METHODS: Patients above 18�years with a rectal ...

BackgroundColorectal cancer (CRC) is the third most commonly diagnosed cancer and the second highest cause of cancer death in the UK. Most cases occur in people over 50 years and CRC often co-exists with other lifestyle related disorders including obesity, type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). These diseases share risk factors related to the metabolic syndrome including ...

Background:?(v) integrins are involved in angiogenesis and melanoma tumourigenesis. Intetumumab (CNTO 95) is a fully human anti-?(v)-integrin monoclonal antibody.Methods:In a multicentre, randomised, phase II study, stage IV melanoma patients were randomised 1?:?1?:?1?:?1 to 1000?mg?m(-2) dacarbazine+placebo (n=32), 1000?mg?m(-2) ...

BackgroundPatients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients ...

A multicentre pilot trial to assess the feasibility of undertaking a full-scale national trial of treatment for mild to moderate hypertension has been performed and is being continued. By February 1977 over 1800 patients had entered the trial and some have been under observation for three years. The results so far show that the definitive trial is administratively and ...

Commentary on: Hutton EK, Hannah ME, Ross SJ, et al.. The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies. BJOG 2011;118:564-77. PMID:21949255

PDF corresponds to the article as it appeared upon acceptance. Fully formatted PDF and full text (HTML) versions will be made available soon. Study Protocol. ECSSIT- Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU ...

Osteoarthritis; Post-Traumatic Arthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis; Perthes Disease

Objective To determine for how long after a first unprovoked seizure a driver must be seizure-free before the risk of recurrence in the next 12 months falls below 20%, enabling them to regain their driving licence.Design Randomised controlled trial: Multicentre study of early Epilepsy and Single Seizures (MESS).Setting UK hospital outpatient clinics from 1 ...

Objective To assess which of three triage strategies for women with borderline abnormal cervical smear results in the best psychosocial outcomes.Design Pragmatic, non-blinded, multicentre, randomised controlled trial.Setting 18 family planning clinics across Australia, covering both urban and rural areas, between January 2004 and ...

BackgroundControlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now.Methods900 patients ...

Objective To estimate the cost effectiveness of alternative methods of managing low grade cervical cytological abnormalities detected at routine screening.Design Cost analysis within multicentre individually randomised controlled trial.Setting Grampian, Tayside, and Nottingham.Participants 4201 women with low grade ...

BackgroundPatients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher levels of dependency care after surgery. We propose a pragmatic multi-centre randomised controlled trial of level of dependency and ...

Clonality of multicentric breast cancer has traditionally been difficult to assess. We aimed to assess this using analysis of TP53 status (expression and mutation status). These results were then incorporated into an analysis of prognostic factors in multicentric tumours in a 10-year follow up study. Clonal status of multicentric ...

Backgroundlaminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been ...

BackgroundComprising of both organisational and patient level components, collaborative care is a potentially powerful intervention for improving depression treatment in UK primary Care. However, as previous models have been developed and evaluated in the United States, it is necessary to establish the effect of collaborative care in the UK in order to determine whether this innovative treatment ...

First-trimester chorion villus sampling has the advantage over second-trimester amniocentesis of allowing earlier prenatal diagnosis of various genetic and cytogenetic disorders in the fetus (and therefore earlier termination in affected pregnancies) but the relative safety and diagnostic accuracy remain unclear. Between 1985 and 1989, 3248 women seeking prenatal diagnosis, principally because of ...

ObjectiveTo investigate whether acupuncture is effective for the induction of labour in post-term pregnancies.DesignA double-blind multicentre randomised controlled study.SettingsAarhus University Hospital and Herning Regional Hospital, Denmark.PopulationOne hundred and twenty-five healthy women with uneventful pregnancies at gestational week ...

AbstractA systematic review revealed three small randomised controlled trials of yoga for low back pain, all of which showed effects on back pain that favoured the yoga group. To build on these studies a larger trial, with longer term follow-up, and a number of different yoga teachers delivering the intervention is required. This study protocol describes the details of a ...

BackgroundAmyotrophic lateral sclerosis (ALS) is defined as a disease of the motor neurones, although several studies indicate involvement of the sensory nervous system.AimTo evaluate the sensory nerve conduction studies (NCS) in 88 patients with ALS as part of a European multicentre study.MethodsSeven European clinical neurophysiologists examined consecutive series of ALS ...

BackgroundBased on data from large multicentre US trials, the National Institute for Health and Clinical Excellence (NICE) is advocating a stepped-care model for the management of depression, with �case management� or �collaborative care� for selected patients in primary care.AimTo conduct a pilot study examining the use of graduate mental health workers case managing ...

BackgroundLow back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60�70% of adults are believed to have suffered this problem at some time. Nevertheless, few ...

While radiotherapy is proceeding, tumour cells may proliferate. The use of small individual doses reduces late morbidity. Continuous hyperfractionated accelerated radiation therapy (CHART), which reduces overall treatment from 6-7 weeks to 12 days and gives 36 small fractions, has now been tested in multicentre randomised controlled clinical trials. The ...

Chronic caudal stomatitis with alveolar/buccal mucositis in calicivirus-positive cats is the most severe presentation of feline chronic gingivostomatitis. Refractory cases are helped by antibiotic and anti-inflammatory treatments often including glucocorticoids. In order to evaluate the comparative efficacy of oromucosal administration of recombinant feline interferon omega (rFeIFN-?) versus oral ...

Inosine-pranobex (methisoprinol, isoprinosine; INPX) is the p-acetamidobenzoic salt of N,N-dimethylamino-2-propanol and inosine in a 3:1 molar ratio. In early studies, INPX was found to partially inhibit human immunodeficiency virus (HIV) and to increase the immunocompetence of HIV-infected subjects in vitro. We report the results of a randomised, ...

1. Potential therapies for ischaemic stroke include agents to reduce oedema, to improve cerebral perfusion, to reduce excitotoxic damage, to minimise free-radical induced injury and to reduce complications such as deep venous thrombosis. 2. Of the anti-oedema drugs, steroids are ineffective and possibly dangerous; intravenous glycerol is unproven. 3. Haemodilution to reduce whole blood viscosity ...

This paper explains the rationale behind the intervention used for a large multi-centred randomised controlled trial for men following transurethral resection of prostate or radical prostatectomy. It shows the content of the protocol used and explains why this particular protocol of pelvic floor muscle exercises and urge suppression techniques was chosen ...

BACKGROUND: The acute respiratory distress syndrome (ARDS) is a common cause of respiratory failure in critically ill patients. Experimental studies suggest that treatment with beta agonists may be helpful in ARDS. The Beta Agonist Lung Injury TrIal (BALTI-2) is a multicentre, pragmatic, randomised, double-blind, placebo-controlled clinical trial which ...

Objective To determine the relative benefits and risks of laparoscopic fundoplication surgery as an alternative to long term drug treatment for chronic gastro-oesophageal reflux disease (GORD).Design Multicentre, pragmatic randomised trial (with parallel preference groups).Setting 21 hospitals in the United Kingdom.Participants 357 ...

In this study, the efficacy and safety of a treatment with the combination imidacloprid 10 %/ moxidectin 1.0 % spot-on (Advocate(�) spot-on for small cats and ferrets) was tested in 39 ferrets naturally infested with ear mites (Otodectes cynotis). The study was performed as a multicentre, non-randomised, non-controlled (all study animals were treated) ...

BACKGROUND: Eribulin inhibits microtubule dynamics via a mechanism distinct from that of other tubulin-targeting drugs, inducing cell-cycle arrest and tumour regression in preclinical models. We assessed the activity and safety of eribulin in four strata of patients with different types of soft-tissue sarcoma. METHODS: In this non-randomised multicentre ...

(MYCER) cells with E2 for 2 days produced multiple karyotypic abnormalities, including marked aneuploidy(MYCER) cells treated with E2 displayed aneuploidy (B), double minute chromosomes (D), and dicentric chromosomes, but when treated with E2 exhibited marked aneuploidy (C) and multicentric chromosomes (F). Table 2

OBJECTIVE: To assess the diagnostic yield of different sampling devices used in cervical screening. DESIGN: Meta-analysis of randomised and quasi-randomised studies. SETTING: All randomised and quasi-randomised studies comparing the yield of cytological or histological abnormalities when two or ...

Objective To determine if the macrolide clarithromycin affects mortality and cardiovascular morbidity in patients with stable coronary heart disease.Design Centrally randomised multicentre trial. All parties at all stages were blinded. Analyses were by intention to treat.Setting Five Copenhagen University cardiology departments and a coordinating ...

The long-term efficacy and safety of sodium valproate and carbamazepine in adult outpatients with newly diagnosed primary generalised or partial and secondarily generalised seizures were compared in a randomised, open, multicentre study at 22 neurology outpatient clinics. Patients were randomised to oral sodium valproate (Epilim EC ...

BackgroundThe success rate of IVF treatment is low. A recent systematic review and meta-analysis found that the outcome of IVF treatment could be improved in patients who have experienced recurrent implantation failure if an outpatient hysteroscopy (OH) is performed before starting the new treatment cycle. However, the trials were of variable quality, leading to a call for a large and high-quality ...

149 previously untreated patients with Parkinson's disease were recruited over a three year period and randomly allocated to either low dose levodopa-carbidopa (< or = 600/150 mg/day) or low dose bromocriptine (< or = 30 mg/day). A five year follow up is reported on the 126 patients who completed the dose titration and who have not developed features of atypical Parkinsonism. ...

Background: Aggressive challenging behaviour in people with intellectual disability (ID) is frequently treated with antipsychotic drugs, despite a limited evidence base. Method: A multi-centre randomised controlled trial was undertaken to investigate the efficacy, adverse effects and costs of two commonly prescribed antipsychotic drugs (risperidone and ...

Objective To compare standard management of keeping wounds dry and covered with allowing wounds to be uncovered and wet in the first 48 hours after minor skin excision.Design Prospective, randomised controlled, multicentre trial testing for equivalence of infection rates.Setting Primary care in regional centre, Queensland, Australia.Participants 857 ...

BackgroundNeonatal respiratory distress syndrome, as a consequence of preterm birth, is a major cause of early mortality and morbidity during infancy and childhood. Survivors of preterm birth continue to remain at considerable risk of both chronic lung disease and long-term neurological handicap. Progesterone is involved in the maintenance of uterine quiescence through modulation of the ...

BackgroundUrinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of ...

BackgroundBreast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor ...

Following the diagnostic indications of the Guidelines for the diagnosis and therapy of juvenile headache, we present the results of a prospective, multicentre study of headache patients aimed at evaluating the utility of neuroradiologic testing in the diagnosis of headache. A total of 6535 subjects up to age 18 were studied, and 1485 underwent neuroimaging testing based on ...

AbstractLymphosarcoma, a common canine hematopoietic neoplasm, occurs in multicentric, alimentary, mediastinal, and extranodal forms. Alimentary lymphoma accounts for approximately 5% of cases and is less easily diagnosed than the more common multicentric form. Chemotherapy is often effective, but recent therapeutic advances hold great promise for success ...

BackgroundThere is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time.The aims of this randomised trial are to assess whether elective birth at 37 weeks ...

BackgroundSecuring and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on ...

BackgroundClavicle fractures account for around 4% of all fractures and up to 44% of fractures of the shoulder girdle. Fractures of the middle third (or mid-shaft) account for approximately 80% of all clavicle fractures. Management of this group of fractures is often challenging and the outcome can be unsatisfactory. In particular it is not clear whether surgery produces better outcomes than ...

Aims:? Efficacy of antimuscarinic therapy for overactive bladder (OAB) has been demonstrated; however, the durability of its effects is unknown. The study was conducted to evaluate symptom change and retreatment rate after discontinuation of antimuscarinic therapy. Also, we tried to find risk factors for retreatment. Methods:? This was a prospective, randomised, open-label, ...

ObjectiveTo determine whether spa therapy, plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment, in the management of knee osteoarthritis.MethodsLarge multicentre randomised prospective clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria, attending ...

BackgroundMedical management of thyroid eye disease remains controversial due to a paucity of high quality evidence on long-term treatment outcomes. Glucocorticoids are known to be effective initially but have significant side-effects with long-term use and recrudescence can occur on cessation. Current evidence is conflicting on the efficacy of radiotherapy and non-steroid systemic ...

BACKGROUND & AIMS: The evidence in support of Early Enteral Nutrition (EEN) after upper gastrointestinal surgery is inconclusive. The aim of this study was to determine if EEN improved clinical outcomes and shortened length of hospital stay. METHODS: Open, prospective multicentre randomised controlled trial within a regional UK Cancer Network. One ...

BackgroundOpen transthoracic oesophagectomy is the standard treatment for infracarinal resectable oesophageal carcinomas, although it is associated with high mortality and morbidity rates of 2 to 10% and 30 to 50%, respectively, for both the abdominal and thoracic approaches. The worldwide popularity of laparoscopic techniques is based on promising results, including lower postoperative morbidity ...

BACKGROUND: Disease management programs have been shown to improve health outcomes in high risk individuals in many but not all health care systems. METHODS: Young @ Heart is a multi-centre, randomised controlled study of a nurse-led, home-based intervention (HBI) program vs. usual care (UC) in privately insured patients in Australia aged ?45years ...

Aims and methods:In this double-blind, double-dummy, randomised, parallel group, multicentre study, the efficacy of dosing and re-dosing of a fixed combination of indomethacin, prochlorperazine and caffeine (Indoprocaf) was compared with encapsulated sumatriptan in the acute treatment of two migraine attacks. Additionally, in the group taking Indoprocaf, ...

ObjectiveTo examine the effects of antenatal education focussing on natural childbirth preparation with psychoprophylactic training versus standard antenatal education on the use of epidural analgesia, experience of childbirth and parental stress in first-time mothers and fathers.DesignRandomised controlled multicentre trial.SettingFifteen antenatal ...

Objectives To compare the effectiveness of an early switch to oral antibiotics with the standard 7 day course of intravenous antibiotics in severe community acquired pneumonia. Design Multicentre randomised controlled trial. Setting Five teaching ...

Whether breast milk influences later neurodevelopment has been explored in non-randomised studies, potentially confounded by social and demographic differences between feed groups. Here in a strictly randomised prospective multicentre trial, Bayley psychomotor and mental development indices (PDI and MDI) were assessed at 18 months ...

BackgroundDepression Care for People with Lung Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3 Trial) will test its ...

BackgroundWithin the spectrum of spontaneous intracerebral haemorrhage there are some patients with large or space occupying haemorrhage who require surgery for neurological deterioration and others with small haematomas who should be managed conservatively. There is equipoise about the management of patients between these two extremes. In particular there is some evidence that patients with lobar ...

BACKGROUND AND PURPOSE: To test the design and feasibility of a very large randomised controlled trial assessing the efficacy and safety of antithrombotic therapy started within 48 hours of symptom onset in patients with suspected acute ischaemic stroke. DESIGN: Randomised controlled multicentre open study, with a 3 x 2 factorial ...

BackgroundVenous thromboembolism (VTE) occurs when blood clots in the leg, pelvic or other deep vein (deep vein thrombosis) with or without transport of the thrombus into the pulmonary arterial circulation (pulmonary embolus). VTE is common in patients with cancer and is increased by surgery, chemotherapy, radiotherapy and disease progression. Low molecular weight heparin (LMWH) is routinely used ...

AIM: To assess pathological and radiological prognostic factors for cancers detected by screening within a multi-centre RCT trial of mammographic screening of younger women. METHOD: The survival of 232 women with screen detected invasive cancer was ascertained. Data on invasive cancer size, histological grade, nodal status, vascular invasion, mammographic spiculation, comedo ...

Currently the use of forceps, brushes or needles during flexible bronchoscopy are the standard tools when diagnosing endobronchial malignancies. The new biopsy technique of cryobiopsy appears to provide better diagnostic samples. The aim of this study was to evaluate cryobiopsy over conventional endobronchial sampling. A total of 600 patients in 8 centres with suspected endobronchial tumours were ...

BackgroundThe Acute Respiratory Distress Syndrome (ARDS) is a common cause of respiratory failure in critically ill patients. Experimental studies suggest that treatment with beta agonists may be helpful in ARDS. The Beta Agonist Lung Injury TrIal (BALTI-2) is a multicentre, pragmatic, randomised, double-blind, placebo-controlled clinical trial which aims ...

Many factors have effect on the enhanced recovery after colon surgery. Not only the technical skill but the perioperative events needed to be optimized by the pre- and postoperative issues. Articles were obtained with search for keywords in Medline electronic database and evidences have been ranked according to the recommendation of the Oxford Evidence-Based Medicine Centre. ...

The management of stroke and transient ischaemic attacks (TIAs) has changed greatly in the last two decades. The importance of good blood pressure control is the hallmark of stroke prevention. Large multicentre trials have proven beyond doubt the value of aspirin in TIAs, warfarin in patients with atrial fibrillation and embolic cerebrovascular symptoms, and carotid ...

The efficacies of two regimens for the treatment of acute clinical mastitis were compared in a randomised multi-centre field trial in Norway, using 657 cows. The purpose was to determine whether repeated intramuscular injections of penicillin G for three days were more effective than a single injection, when given in combination with intramammary treatment ...

The present study compares the efficacy and safety of betahistine dihydrochloride to that of a placebo in recurrent vertigo resulting from Meniere's disease (MD) or in paroxysmal positional vertigo (PPV) of probable vascular origin. The design was double-blind, multicentre and parallel-group randomised. Eleven Italian centres enrolled 144 patients: 75 of ...

ENDIT ("European Nicotinamide Diabetes Intervention Trial") is a large placebo-controlled randomised clinical trial that aimed at studying the efficacy of nicotinamide in the prevention of type 1 diabetes mellitus among first-degree relatives of type 1 diabetic patients with positive islet cell antibodies (ICA). The results presented at the last congress of the European ...

Glaucoma is a condition affecting one or both eyes with raised intraocular pressure (IOP). IOP should be reduced to prevent progression of visual field loss. This study investigates the cost-effectiveness of bimatoprost compared with latanoprost as first-line monotherapies in the treatment of glaucoma in Austria, Finland and France. On the basis of a single multicentre, ...

Influenza vaccines remain largely underused. A promising alternative to current intramuscular vaccines is a trivalent inactivated influenza vaccine (TIV) delivered using a microinjection system to offer a less invasive and possibly more acceptable vaccination. A phase II, multicentre, randomised open-label study in 978 healthy adults (18-57 years) ...

The EORTC Lymphoma Cooperative Group and the Pierre and Marie Curie Group conducted a multicentre randomised trial on clinical stages IIIB-IV Hodgkin's disease from 1981-1986. Two hundred seven patients were registered and 192 randomised. Actuarial survival at five years for the whole group was 68%. Induction chemotherapy with eight ...

Endometrial cancer is a hormone-dependent disease and therefore an adjuvant hormonal therapy might improve the outcome in the early stages of the disease. Between 1983 and 1989, we conducted a randomised trial of 388 patients who received either medroxyprogesterone acetate (MPA) (n=133) or tamoxifen (n=121) orally for 2 years, or were observed only (n=134) after surgical ...

We present a very rare case of simultaneous thymic carcinoids with similar size, one of which showed spontaneous regression. A 68-year-old man was admitted to the hospital because of two similar abnormal masses at his anterior mediastinum on chest computed tomography, one of which had decreased from 25 to 16 mm in diameter. A total thymectomy was performed and the pathologic ...

BackgroundA recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy consultation on daily functioning in older people with mild or moderate dementia and their ...

Please cite this paper as: Suwannachat B, Laopaiboon M, Tonmat S, Siriwachirachai T, Teerapong S, Winiyakul N, Thinkhamrop J, Lumbiganon P. Rapid versus stepwise application of negative pressure in vacuum extraction-assisted vaginal delivery: a multicentre randomised controlled non-inferiority trial. BJOG 2011; DOI: 10.1111/j.1471-0528.2011.02992.x. ...

BackgroundStress urinary incontinence is a common condition affecting approximately 20% of adult women causing substantial individual (quality of life) and economic (119 million Euro/year spent on incontinence pads in the Netherlands) burden. Pelvic floor muscle training (PFMT) is regarded as first line treatment, but only 15-25% of women will be completely cured. Approximately 65% will report ...

ObjectiveTo compare tension-free vaginal tape with colposuspension as primary treatment for stress incontinence.DesignMulticentred randomised comparative trial.SettingGynaecology or urology departments in 14 centres in the United Kingdom and Eire, including university teaching hospitals and district general hospitals.Participants344 women with urodynamic ...

BackgroundMedication can be effective but can also be harmful and even cause hospital admissions. Medication review or pharmacotherapy review has often been proposed as a solution to prevent these admissions and to improve the effectiveness and safety of pharmacotherapy. However, most published randomised controlled trials on pharmacotherapy reviews showed no or little effect ...

BackgroundDupuytren's disease is a progressive fibroproliferative disorder which can result in fixed flexion contractures of digits and impaired hand function. Standard treatment involves surgical release or excision followed by post-operative hand therapy and splinting, however the evidence supporting night splinting is of low quality and equivocal.MethodsA multi-centre, ...

ABSTRACT: BACKGROUND: Gestational hypertension (GH) and pre-eclampsia (PE) can result in severe complications such as eclampsia, placental abruption, syndrome of Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) and ultimately even neonatal or maternal death. We recently showed that in women with GH or mild PE at term induction of labour reduces both high risk situations for mothers as ...

BackgroundGestational hypertension (GH) and pre-eclampsia (PE) can result in severe complications such as eclampsia, placental abruption, syndrome of Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) and ultimately even neonatal or maternal death. We recently showed that in women with GH or mild PE at term induction of labour reduces both high risk situations for mothers as well as the ...

BackgroundAlthough the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to ...

BackgroundCoronary heart disease (CHD) and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI) and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL), decrease medication adherence and appropriate utilisation of ...

In spite of the progresses of knowledge and care, pressure sores continue to be a clinically relevant problem. A double blind randomised controlled trial was organised to assess the efficacy of triticum vulgaris (Fitostimoline) vs placebo in the re-epithelisation of superficial pressure sores. Patients with stage NPUAP II or superficial pressure sores, with an expected ...

BackgroundIn unipolar, and bipolar affective disorders, there is a high risk of relapse that increases as the number of episodes increases. Naturalistic follow-up studies suggest that the progressive development of the diseases is not prevented with the present treatment modalities. It is not known whether centralised and specialised secondary care intervention initiated early after the onset of ...

The AZURE trial is an ongoing phase III, academic, multi-centre, randomised trial designed to evaluate the role of zoledronic acid (ZOL) in the adjuvant therapy of women with stage II/III breast cancer. Here, we report the safety and tolerability profile of ZOL in this setting. Eligible patients received (neo)adjuvant chemotherapy and/or endocrine therapy ...

BackgroundStandard coronary artery bypass graft surgery uses a single internal mammary artery and supplemental vein or radial artery grafts. Several observational studies have suggested a survival benefit with two internal mammary artery grafts compared to a single internal mammary artery graft, but this has not been tested in a randomised trial. The Arterial Revascularisation ...

OBJECTIVE: to provide insight into pregnant women's experiences of participating in a large multi-centre randomised trial. DESIGN: qualitative semi-structured interviews. SETTING: six UK maternity units. PARTICIPANTS: women recruited to the Magpie Trial. The Magpie Trial was a trial of prophylactic anticonvulsants for women with severe pre-eclampsia. ...

Objective To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache.Design Three armed randomised controlled multicentre trial.Setting 28 outpatient centres in Germany.Participants 270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type ...

BackgroundBronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG).The evidence to determine the optimum route of hydration ...

Objectives: evaluation of the effectiveness of a new structured diabetes teaching and treatment programme (DTTP) with specific didactical approaches and topics for geriatric patients with diabetes mellitus.Design: a prospective randomised controlled multi-centre trial.Setting and participants: a total of 155 geriatric patients were randomly admitted to ...

ObjectivesTo evaluate the effectiveness and cost effectiveness of an intensive home visiting programme in improving outcomes for vulnerable families.DesignMulticentre randomised controlled trial in which eligible women were allocated to receive home visiting (n?=?67) or standard services (n?=?64). Incremental cost analysis.Setting40 general practitioner ...

Objective To assess whether vaccination against human papillomavirus (HPV) increases the risk of miscarriage.Design Pooled analysis of two multicentre, phase three masked randomised controlled trialsSetting Multicentre trials in several continents and in Costa Rica.Participants 26?130 women aged 15-25 at enrolment; 3599 pregnancies ...

Controversial results of surgical treatment after induction chemotherapy, especially in relation to the extent of resection, have previously been reported. Mortality and morbidity were studied in the surgical arm of the European Organisation for Research and Treatment of Cancer (EORTC) 08941 trial. EORTC 08941 is a multicentre, prospective, randomised, ...

OBJECTIVES�Pramipexole, a non-ergot dopamine D2/D3 receptor agonist, was investigated as an add on drug in advanced parkinsonian patients with motor fluctuations to assess efficacy, safety, and tolerance.?METHODS�Seventy eight patients of either sex with advanced Parkinson's disease and treatment complications such as motor fluctuations were enrolled into a double blind, placebo controlled, ...

A multicentred, randomised, blind study was started in 1978 to compare propranolol or hyaluronidase with placebo in patients with acute myocardial infarction admitted within 18 hours of onset of symptoms. Patients were randomised to group A and received hyaluronidase, propranolol, or placebo, or, if propranolol was contraindicated, to ...

Objective To determine whether fluoroscopic guidance improves outcomes of injections for greater trochanteric pain syndrome.Design Multicentre double blind randomised controlled study.Setting Three academic and military treatment facilities in the United States and Germany.Participants 65 patients with a clinical diagnosis of greater trochanteric pain ...

BackgroundChronic cough is common and is associated with significant economic and human costs. While cough can be a problematic symptom without serious consequences, it could also reflect a serious underlying illness. Evidence shows that the management of chronic cough in children needs to be improved. Our study tests the hypothesis that the management of chronic cough in children with an ...

BackgroundAllergic rhinitis is one of the most common health complaints worldwide. Complementary and alternative medical approaches have been employed to relieve allergic rhinitis symptoms and to avoid the side effects of conventional medication. Acupuncture has been widely used to treat patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient. Our objective ...

Aim: To evaluate the safety and efficacy of bimatoprost 0.03% once daily or twice daily compared with timolol 0.5% twice daily in patients with glaucoma or ocular hypertension.Methods: Multicentre, double masked, randomised, parallel group, 3 month trial comparing bimatoprost once daily (n=240), bimatoprost twice daily (n=240), and timolol twice daily ...

OBJECTIVE: to study women's and men's satisfaction with two models of antenatal education: natural childbirth preparation with psychoprophylaxis, and standard antenatal education including preparation for childbirth and parenthood but no psychoprophylaxis. DESIGN: randomised controlled multicentre trial. SETTING: 15 antenatal clinics in Sweden between ...

ObjectivesTo assess the efficacy of the interleukin 1 receptor antagonist anakinra in systemic-onset juvenile idiopathic arthritis (SJIA).MethodsA multicentre, randomised, double-blind, placebo-controlled trial was conducted. The primary objective was to compare the efficacy of a 1-month treatment with anakinra (2 mg/kg subcutaneous daily, maximum 100 mg) ...

In a non-randomised study in six centres in the UK, 24 patients with previously untreated small-cell lung cancer of limited extent were treated with a regimen of alternating chemotherapy and radiotherapy to assess response, toxicity, and the feasibility of applying such a regimen on a multicentre basis in the UK. The intention was to give six courses of ...