Lancet
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Optimum duration of anticoagulation for deep-vein thrombosis and pulmonary embolism. Research Committee of the British Thoracic Society.
The optimum duration of anticoagulation therapy for deep-vein thrombosis (DVT) and pulmonary embolism (PE) is not clear. We have carried out a multicentre comparison of 4 weeks' and 3 months' anticoagulation in patients admitted to hospital with acute DVT, PE, or both. Of 712 patients enrolled, 358 were assigned 4 weeks' treatment and 354 3 months'. ⋯ By contrast, among medical patients the rate was 12.8%, with a clear difference in favour of 3 months' treatment. If venous thromboembolism arises after surgery, 4 weeks of anticoagulation should be adequate. In other settings, patients with new DVT, PE, or both, who do not have a persisting underlying cause or risk factor should receive anticoagulants for 3 months.
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Randomized Controlled Trial Clinical Trial
Placebo-controlled trial of prednisolone in children intubated for croup.
Many studies have attempted to find out whether steroid treatment is beneficial in children with croup, but the results have been inconclusive. We have done a prospective placebo-controlled study of the effect of prednisolone on two clinical endpoints--the duration of intubation and the need for reintubation. ⋯ The median duration of intubation was 138 (95% CI 118-160) h in children who received placebo and 98 (85-113) h in the prednisolone group. Steroid therapy reduces the duration of intubation and the need for reintubation in children intubated for croup.
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Randomized Controlled Trial Clinical Trial
Safety and immunogenicity of single-dose live oral cholera vaccine CVD 103-HgR in 5-9-year-old Indonesian children.
Oral vaccines offer great promise as public-health measures to prevent disease in less-developed countries. CVD 103-HgR, a genetically engineered, attenuated, Vibrio cholerae O1 strain has proved effective in industrialised countries. We have assessed the safety, immunogenicity, and excretion of this live cholera vaccine in children in north Jakarta, Indonesia. 412 children aged 5-9 years received single doses of 5 x 10(6), 5 x 10(7), 5 x 10(8), 5 x 10(9), or 1 x 10(10) colony forming units (CFU) of CVD 103-HgR or placebo (5 x 10(8) inactivated Escherichia coli K-12) with buffer. ⋯ By contrast, a single 5 x 10(9) CFU dose of vaccine resulted in high rates (75% and 87%) of seroconversion with two different batches of vaccine. A batch prepared with a centrifugation step gave significantly higher geometric mean titres (16-fold increase over baseline) than did a batch in which there was a filtration step between fermentation and lyophilisation (10-fold increase over baseline). At a 5 x 10(9) CFU dose, CVD 103-HgR is well tolerated and highly immunogenic in Indonesian children and should therefore be further investigated for use as a one-dose live oral cholera vaccine in developing countries.
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Randomized Controlled Trial Comparative Study Clinical Trial
Randomised trial of cardiotocography alone or with ST waveform analysis for intrapartum monitoring.
It is possible to record the fetal electrocardiographic waveform (ECG) from the scalp electrode used in labour for detection of fetal heart rate. Animal and observational studies of changes in the ST waveform of the ECG during hypoxia suggest that a combination of heart rate and ST waveform analysis might improve the predictive value of intrapartum monitoring. In a randomised trial, we have studied intervention rates and neonatal outcome for high-risk labours monitored either by conventional cardiotocography (CTG) or by ST waveform analysis plus CTG. 1200 women with pregnancy of at least 34 weeks' gestation were assigned to the groups when the decision to apply a fetal scalp electrode was made. ⋯ The review of recordings showed that the reduction in intervention rate was among cases with CTG patterns classified as normal or intermediate, whereas there was no difference in intervention rates among cases with abnormal recordings. Our findings confirm that ST waveform analysis discriminates CTG changes in labour and that our protocol for interpretation is safe. Further randomised studies are warranted.
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Randomized Controlled Trial Comparative Study Clinical Trial
Ondansetron + dexamethasone vs metoclopramide + dexamethasone + diphenhydramine in prevention of cisplatin-induced emesis. Italian Group For Antiemetic Research.
Ondansetron, a selective serotonin-receptor antagonist, is an effective antiemetic for patients receiving high-dose cisplatin chemotherapy. However, no comparison has been made between a combination of a serotonin antagonist and dexamethasone, which also has antiemetic properties, with currently available antiemetic regimens. 289 consecutive cancer patients receiving cisplatin chemotherapy (much greater than 50 mg/m2) were randomised to receive one of the following intravenous antiemetic regimens: ondansetron 0.15 mg/kg, before and after cisplatin, + dexamethasone 20 mg before cisplatin (treatment A) or metoclopramide 3 mg/kg, before and after cisplatin, + dexamethasone + diphenhydramine 50 mg before cisplatin (treatment B). From day 2 to day 4, all patients received oral metoclopramide and intramuscular dexamethasone. 267 patients (136 receiving treatment A and 131 treatment (B) were available for analysis. ⋯ Patients receiving treatment B noted significantly more sedation than patients receiving treatment A (11.8% vs 2.1%; p less than 0.005). Extrapyramidal reactions were present only with treatment B (2.7%). Ondansetron + dexamethasone is more effective and better tolerated than metoclopramide + dexamethasone + diphenhydramine in the prevention of cisplatin-induced nausea and emesis.