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Biomedical subjects

A Leach

Publications and source records attributed to A Leach.

At least 19 recordsLinked to original sources
PubMed2007

Safety and immunogenicity of the RTS,S/AS02A candidate malaria vaccine in children aged 1-4 in Mozambique.

BACKGROUND: The development of a malaria vaccine remains a public health priority for sub-Saharan Africa. RTS,S/AS02A candidate malaria vaccine has been shown to be safe and immunogenic in previous studies in adults and staggered dose-escalation studies in children in The Gambia. However, genetic features and the intensity of malaria transmission may modify the safety and immune response of a vaccine. OBJECTIVE: We carried out a phase I, double-blind randomized controlled trial in 60 children aged 1-4 in Mozambique to evaluate the safety, reactogenicity and immunogenicity of the paediatric vaccine dose (fixed 25 microg RTS,S in 0.25 ml) of RTS,S/AS02A, prior to undertaking a planned larger phase IIb proof-of-concept of efficacy study in the same population. METHOD: Children were randomized to receive either RTS,S/AS02A or Engerix-B vaccine. Monitoring of safety and reactogenicity included detailed clinical and laboratory analyses and assessment of adverse events (AEs). RESULTS: The RTS,S/AS02A was found to be safe and well tolerated. Serious adverse events were balanced between both groups and none was related to vaccination. The frequency of adverse events reported with RTS, S/AS02A was comparable to previous studies in children. Grade 3 AEs were infrequent (one case of pain, one of fever in each group and some swelling greater than 20 mm in diameter), transient and resolved without sequelae. RTS,S/AS02A was highly immunogenic for anti-circumsporozoite protein antibody response and induced a strong anti-hepatitis-B surface antigen response.

Alanine Transaminase↗
PubMed2004

A paralleling device and ethylene vinyl acetate baffles for use with mandibular distraction osteogenesis: technical note.

A novel method for planning the placement of intra-oral lengthening devices using a paralleling device is described and illustrated with a case report. Simple radiographic measurements and study models are all that is required to construct a simple acrylic splint with guides, which allows accurate positioning of the distractors at surgery. The construction of ethylene vinyl acetate (EVA) baffles to prevent trauma to the labial mucosa from the intra-oral link arms is a technique that enhances patient comfort during distraction of the mandible. The case report demonstrates the application of the surgical planning technique and the use of EVA baffles for a patient with an overjet of 21.5 mm.

Acrylic Resins↗
PubMed2003

The subjective experience of early postoperative pain following retrobulbar anaesthesia for enucleation and primary orbital implant.

INTRODUCTION: We performed a prospective audit of the level of postoperative pain experienced by patients following enucleation with insertion of a primary orbital implant after preincisional regional retrobulbar anaesthesia using bupivacaine 0.75% with 1:100,000 adrenaline. MATERIALS AND METHODS: An 11-point numerical ranking box scale was used to measure the subjective experience of postoperative pain following enucleation with insertion of a primary orbital implant in 40 patients with uveal melanoma. Surgery was performed under general anaesthesia with a supplementary peroperative retrobulbar injection of bupivacaine 0.75%/adrenaline 1:100,000. Pain scores were measured for the first 8 hours following administration of the block. RESULTS: The sample included 19 female and 21 male patients with a mean age of 66.7 years (31-87). At four hours post block, 80% were still pain free with 17% experiencing only mild to moderate pain (BS-11 = 1-4). Thirty-four (85%), twenty-eight (70%) and twenty-seven (67%) patients remained pain free at 2, 3 and 4 hours, respectively with no additional analgesia. The remainder scored BS-11 of 1-4 in 92% of cases. Twenty percent required supplementary analgesia (paracetemol in 78% cases) by 5 hours and 57% by 8 hours. BS-11 at 8 hours were 0 in 50%, 1-4 in 22% and 5-10 in 10% of patients (17% asleep). No complications using this technique were recorded. DISCUSSION: Using a preincisional retrobulbar injection of bupivacaine with adrenaline, BS-11 pain scores remained low with no or minimal additional analgesia for up to 4 hours post surgery. In combination with oral analgesia, effective pain control was provided in most cases for up to 8 hours post block.

Adult↗
PubMed2001

A case of difficult pain in a patient with chronic renal failure and calciphylaxis.

A difficult pain occurred in a man with chronic renal failure as a result of the underlying condition of calciphylaxis. In this condition, calcification of small and medium-sized arteries occurs, which may result in ischemia and gangrene. In general, the prognosis is poor, with mortality rates ranging from 23-63%. Pain associated with this condition has been previously reported. In this report, the pain occurred in the lower limbs and penis, and was associated with local necrosis. The pain was observed to be significantly worse on dialysis. A multiprofessional approach to care ultimately resulted in good symptom control.

Calciphylaxis↗
PubMed2001

Update on orthognathic surgery.

This article gives an account of contemporary methods in orthognathic surgery, highlighting which patients are appropriate for such surgery. In order to make the case relevant, a single patient is tracked through her orthodontic treatment, surgery and final outcome.

Female↗
PubMed2000

Antibiotics for persistent nasal discharge (rhinosinusitis) in children.

BACKGROUND: Nasal discharge (rhinosinusitis) is the result of inflammation of the mucosa of the upper respiratory tract, and is usually due to either infection or allergy. OBJECTIVES: To determine the effectiveness of antibiotics versus placebo or standard therapy in treating children with persistent nasal discharge (>10 days). SEARCH STRATEGY: The Cochrane Controlled Trials Register, MEDLINE, EMBASE, and bibliographies of relevant articles were searched. Authors and pharmaceutical companies were contacted. Date of most recent searches: March 2000. SELECTION CRITERIA: All randomized controlled trials that compared antibiotics versus placebo or standard therapy (decongestants or nasal saline drops). Trials which included the use of other medications were included if all participants were allowed equal access to such medications or if the additional or alternative therapies were regarded as ineffective. Trials that only combined or compared antibiotics with surgery, or sinus puncture and lavage, were not included in the review. DATA COLLECTION AND ANALYSIS: Data were extracted by a single reviewer for the following outcomes: clinical failure, failure to improve, clinical improvement, time to resolution, complications, side-effects and bacteriologic failure. For the dichotomous outcome variables of each individual study, proportional and absolute risk reductions were calculated using a modified intention-to-treat analysis. The summary weighted risk ratio and 95% confidence interval (fixed effects model) were calculated using the inverse of the variance of each study result for weighting (Cochrane statistical package, REVMAN version 4.3). MAIN RESULTS: A total of five studies involving 401 children compared antibiotics with placebo or standard therapy. Only one of the seven outcomes (clinical failure) was reported in all studies. Around 45% of children did not have a clinical success documented when reviewed 2-6 weeks after randomization. The control event rate varied from to 47-71% (mean 56%). The risk ratio estimated using a fixed effects model was 0.72 (95% CI 0.59, 0.89). The estimated effect size was consistent in four of the five studies. REVIEWER'S CONCLUSIONS: For children with persistent nasal discharge or older children with radiographically confirmed sinusitis, the available evidence suggests that antibiotics given for 10 days will reduce the probability of persistence in the short to medium-term. The benefits appear to be modest and around six children must be treated in order to achieve one additional cure. No long term benefits have been documented. These conclusions are based on a small number of small randomized controlled trials and additional larger well-designed studies are indicated.

Adolescent↗
PubMed2000

Season of birth is not associated with delayed childhood mortality in Upper River Division, The Gambia.

There is evidence that season of birth may predict adult mortality from infectious diseases in rural Gambia. Using data collected over a five-year period from the rural, eastern region of the Gambia, we examined whether the season of birth influences mortality in childhood. 26 894 births and 3776 deaths among children under the age of five years were recorded in this region during the period 1989-1993. The estimated 1-4 year population was 95 355. In children aged 1-4 years, the mortality rate per 1000 per year was 16.1 (95% CI 14.9, 17.2) for those born in the 'harvest' season (January to June), which was not significantly different from the rate of 17.9 (95% CI 16.7, 19.0) recorded for those born in the 'hungry' season (July to December) (age-stratified Mantel-Haenszel mortality ratio 0. 91, 95% CI 0.83, 1.01; p = 0.08). Nearly all deaths of 1-4 year olds were attributed to infectious diseases, with malaria accounting for over 40%. None of the cause-specific child mortality rates differed significantly according to the season of birth. These data suggest that beyond infancy, when it is easier to separate the effect of season on cause of death from that of the season of birth, there is no marked difference in the rate of death between Gambian children born in the harvest season and those born in the hungry season.

Birth Rate↗
PubMed1999

Preparation for a pneumococcal vaccine trial in The Gambia: individual or community randomisation?

In preparation for a large phase-3 trial of pneumococcal polysaccharide/conjugate vaccine among infants in The Gambia, the relative merits of community and individual randomisation were considered. The impact of vaccination might be enhanced in a community randomised trial if there was a substantial 'herd' effect. This might occur if those vaccinated comprise a substantial proportion of potential transmitters of infection. However, there are few data on the sources of pneumococcal infections in The Gambia and with the high degree of mobility of people in The Gambia, it seems unlikely that any herd effect would be strong. In the absence of a herd effect, a community-randomised trial would have lower power for the mortality end-points compared to an individually randomised trial of the same size. In addition, a community-randomised trial might not provide sufficient control against potential confounders and blinding might be difficult to sustain if the vaccine has a strong effect. An individually randomised trial seems a better strategy under the conditions prevailing in The Gambia.

Bacterial Vaccines↗
PubMed1999

An evaluation of the informed consent procedure used during a trial of a Haemophilus influenzae type B conjugate vaccine undertaken in The Gambia, West Africa.

It has recently been debated whether it is possible or desirable to have one internationally recognised standard of "informed consent" or whether research ethics should be adapted to the culture and educational level of the study population. This study examined the attitudes of the Gambian people to consent to medical research, and evaluated the informed consent process used in a major efficacy trial of a Haemophilus influenzae vaccine. Consent was requested after parents had received a verbal explanation and an information sheet which described the vaccine trial in a local language. A semi-structured interview was conducted with 137 acceptors and 52 refusers. Certain points of knowledge were recalled well by the acceptors; 90% knew the purpose of the vaccine was to prevent disease, but the placebo control design was understood by only 10%. The prime motive for consenting was to receive the HIB vaccine (93%) and that for refusing was that the vaccine was experimental (35%) and might have unknown side effects (29%). Although parents took advice from researchers (50%), health workers (24%), friends (16%) and family (12%), in all cases the decision was made by one of the child's parents. Only 1% of parents sought the opinion of traditional or religious leaders. The principles of informed consent, that it should be free, autonomous and informed were affirmed by this community. Therefore, in The Gambia, the international code of informed consent is appropriate.

Adult↗
PubMed1999

Streptococcus pneumoniae antibiotic resistance in Northern Territory children in day care.

BACKGROUND: There is evidence that the rapid rise in Streptococcus pneumoniae (SP) antimicrobial resistance seen in other countries may have commenced in Australia. Streptococcus pneumoniae carriage and resistance levels are described for urban Northern Territory children in day care. METHODS: A prospective cohort study was conducted of 250 children in nine Darwin day care centres between 24 March and 15 September 1997. Each fortnight nasopharyngeal swabs were collected from children, and parents were interviewed about medications administered. RESULTS: Streptococcus pneumoniae was detected in 52% (1028/1974) of all nasopharyngeal swabs. Streptococcus pneumoniae was isolated from 92% (231/250) of children at some time. Penicillin resistance was found in 30% (312/1028) of isolates using a screening test. Of these, 256 (82%) had resistance confirmed by E-test. Two hundred and one (20% of all isolates) had intermediate penicillin resistance and 55 (5% of all isolates) had high level resistance. Ceftriaxone resistance was found in 19% of children's first isolates. Resistance to other antibiotics was also common: co-trimoxazole 45%, erythromycin 17%, tetracycline 17% and chloramphenicol 13%. A total of 17% (172/1028) of the isolates were multiresistant. The average fortnightly proportion of children given antibiotics was 16% (405/2476). CONCLUSION: Levels of intermediate and high level penicillin resistance in this day care population are consistent with previous data from the Northern Territory, and considerably higher than the rest of Australia. The national trend of increasing pencillin resistance is likely to continue.

Australia↗
PubMed1999

Neonatal mortality in a rural area of The Gambia.

Childhood mortality in Upper River Division, The Gambia is high, 99 per 1000 mid-year population, and 27% of deaths occur is the neonatal period. The aims of the present study were to describe patterns of neonatal death and to identify risk factors. Cause of death was investigated using a neonatal post-mortem questionnaire, and a population-based, matched case-control study was conducted to identify potential risk factors. The neonatal mortality rate in Upper River Division was 39 per 1000 live births (95% CI 36.8-41.2). The rates in the early and late neonatal periods were 21.0 (19.4-22.6) and 18.0 (16.5-19.5), respectively. Infection accounted for 57% of all deaths. In the early neonatal period, 30% of deaths were due to prematurity. Only 55% of babies who died presented for treatment and 84% died at home. Risk factors for neonatal death were primiparity (OR 2.18), previous stillbirth (OR 3.19), prolonged labour (OR 2.80) and pre-lacteal feeding (OR 3.38). A protective effect was seen in association with delivery by a trained traditional birth attendant (OR 0.34) and the application of shea nut butter, a traditional medicine, to the cord stump (OR 0.07). This study has identified the need to understand the reasons underlying the widespread use of pre-lacteal feeds and the barriers to health service use in this community in order to plan effective interventions.

Case-Control Studies↗
PubMed1999

Paravertebral block in the management of liver capsule pain after blunt trauma.

We present a case of liver capsule pain after blunt abdominal trauma. The patient was unable to tolerate patient-controlled i.v. opioids, and epidural infusion of local anaesthetic was considered undesirable because of the potential risk of complications. Pain was managed successfully with paravertebral infusion of local anaesthetic at the right T10 level. Innervation of the liver and possible mechanisms of visceral pain processing are discussed.

Adult↗