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23\04\2012 - Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes

Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial Background Intensive basal-bolus insuli...
26\03\2012 - Intermittent preventive therapy for malaria with monthly artemether—lumefantrine for the post-discharge management of severe anaemia in children aged 4—59 months in southern Malawi

Intermittent preventive therapy for malaria with monthly artemether—lumefantrine for the post-discharge management of severe anaemia in children aged 4—59 months in southern Malawi: a multicentre, randomised, placebo-controlled trial Background Young children with severe malari...
19\03\2012 - Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN)

Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study Background Erlotinib, docetaxel, and pemetrexed are approved for the second-l...
12\03\2012 - Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction

Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction: a randomised trial Background Intracoronary administration of an abciximab bolus during a primary percutaneous coronary intervention...
05\03\2012 - Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer

Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial Background Erlotinib has been shown to improve progression-free survival compar...
27\02\2012 - Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma

Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial Background We aimed to improve the outcomes for locoregionally advanced nasopharyngeal carcinoma by testing the feasibility and safety of...
20\02\2012 - Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO)

Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial Background The anti-HER2 monoclonal antibody trastuzumab and the tyrosine kinase inhibitor lapatinib have complementary mechanisms of action and synergistic an...
13\02\2012 - Intravenous aflibercept for treatment of recurrent symptomatic malignant ascites in patients with advanced ovarian cancer

Intravenous aflibercept for treatment of recurrent symptomatic malignant ascites in patients with advanced ovarian cancer: a phase 2, randomised, double-blind, placebo-controlled study Background Targeting of VEGF is a potential therapeutic option in patients with malignant ovarian ascite...
06\02\2012 - Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease

Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial Background The effects of constant-current deep brain stimulation (DBS) have not been studied in controlled trials in patients with Parkinson's disease. We a...
30\01\2012 - Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC)

Adjuvant capecitabine and oxaliplatin for gastric cancer after D2 gastrectomy (CLASSIC): a phase 3 open-label, randomised controlled trial Background D2 gastrectomy is recommended in US and European guidelines, and is preferred in east Asia, for patients with resectable gastric cancer. Ad...
23\01\2012 - Firategrast for relapsing remitting multiple sclerosis

Firategrast for relapsing remitting multiple sclerosis: a phase 2, randomised, double-blind, placebo-controlled trial Background Monoclonal antibody therapy against α4β-integrin is efficacious in patients with multiple sclerosis (MS) with some safety concerns. We assessed the saf...
16\01\2012 - Participation and yield of colonoscopy versus non-cathartic CT colonography in population-based screening for colorectal cancer

Participation and yield of colonoscopy versus non-cathartic CT colonography in population-based screening for colorectal cancer: a randomised controlled trial Background Screening for colorectal cancer is widely recommended, but the preferred strategy remains unidentified. We aimed to comp...
09\01\2012 - Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study)

Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial Background Conventional anticoagulant treatment for acute deep vein thrombosis (DVT) effectively prevent...
19\12\2011 - Long-term effect of aspirin on cancer risk in carriers of hereditary colorectal cancer

Long-term effect of aspirin on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial Background Observational studies report reduced colorectal cancer in regular aspirin consumers. Randomised controlled trials have shown reduced ris...
14\12\2011 - Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome

Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study Background Everolimus, an oral inhibitor of the mammalian target of rapamycin (mTOR), has ...
05\12\2011 - Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation in patients with multiple myeloma

Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation in patients with multiple myeloma (BMT CTN 0102): a phase 3 biological assignment trial Background Autologous haemopoietic stem-cell transplantation (HSCT) improves...
28\11\2011 - Cardiac stem cells in patients with ischaemic cardiomyopathy

Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial Background c-kit-positive, lineage-negative cardiac stem cells (CSCs) improve post-infarction left ventricular (LV) dysfunction when administered to animals. We undertook a p...
21\11\2011 - Pridopidine for the treatment of motor function in patients with Huntington's disease

Pridopidine for the treatment of motor function in patients with Huntington's disease (MermaiHD): a phase 3, randomised, double-blind, placebo-controlled trial Background Huntington's disease is a progressive neurodegenerative disorder, characterised by motor, cognitive, and behavioural de...
14\11\2011 - Effects of intensive glucose lowering on brain structure and function in people with type 2 diabetes

Effects of intensive glucose lowering on brain structure and function in people with type 2 diabetes (ACCORD MIND): a randomised open-label substudy Background People with type 2 diabetes are at risk of cognitive impairment and brain atrophy. We aimed to compare the effects on cognitive fu...
07\11\2011 - Phase 1—2 study of docetaxel plus aflibercept in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer

Phase 1—2 study of docetaxel plus aflibercept in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer Background Biologically targeted therapies have been postulated as a viable strategy to improve outcomes for women with ovarian cancer. We assessed the safety,...
31\10\2011 - Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging

Safety and efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial Background Dalcetrapib modulates cholesteryl ester transfer protein (CETP) activity to raise high-density lipoprotein cholesterol (HDL-C). ...
16\10\2011 - Sequential versus combination chemotherapy for the treatment of advanced colorectal cancer (FFCD 2000—05)

Sequential versus combination chemotherapy for the treatment of advanced colorectal cancer (FFCD 2000—05): an open-label, randomised, phase 3 trial Background The optimum use of cytotoxic drugs for advanced colorectal cancer has not been defined. Our aim was to investigate whether co...
09\10\2011 - Intraoperative MRI guidance and extent of resection in glioma surgery

Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial Background Intraoperative MRI is increasingly used in neurosurgery, although there is little evidence for its use. We aimed to assess efficacy of intraoperative MRI guidance on extent of re...
02\10\2011 - Relocating fat to treat obesity, diabetes

Relocating fat to treat obesity, diabetes: An Indo-Australian research team has found a novel way to deal with the modern metabolic disorders obesity and type 2 diabetes. They have transplanted body fat tissues of rats to chest and thigh regions thereby increasing the activity of fat tissue-secre...
25\09\2011 - Treatment of severe neurological deficits with IgG depletion through immunoadsorption in patients with Escherichia coli

Treatment of severe neurological deficits with IgG depletion through immunoadsorption in patients with Escherichia coli O104:H4-associated haemolytic uraemic syndrome: a prospective trial Background In May 2011, an outbreak of Shiga toxin-producing enterohaemorrhagic E coli O104:H4 in northe...
19\09\2011 - Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer

Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial Background Platinum-based doublet chemotherapy is recommended to treat advanced non-small-cell lung cancer (NSC...
12\09\2011 - Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide

Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial Background Asthma exacerbations during pregnancy are common and can be associated with substantial maternal and fetal morbidity. Treatment decision...
04\09\2011 - Early assessment of cancer outcomes in New York City firefighters after the 9\11 attacks

Early assessment of cancer outcomes in New York City firefighters after the 9/11 attacks: an observational cohort study Background The attacks on the World Trade Center (WTC) on Sept 11, 2001 (9/11) created the potential for occupational exposure to known and suspected carcinogens. We exami...
27\08\2011 - Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen

Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials Background As trials of 5 years of tamoxifen in early breast cancer mature, the relevance of hormone receptor measurements (and other patie...
20\08\2011 - The effects of the cardiac myosin activator, omecamtiv mecarbil, on cardiac function in systolic heart failure

The effects of the cardiac myosin activator, omecamtiv mecarbil, on cardiac function in systolic heart failure: a double-blind, placebo-controlled, crossover, dose-ranging phase 2 trial Background Many patients with heart failure remain symptomatic and have a poor prognosis despite existin...
13\08\2011 - Exon skipping and dystrophin restoration in patients with Duchenne muscular dystrophy after systemic phosphorodiamidate morpholino oligomer treatment

Exon skipping and dystrophin restoration in patients with Duchenne muscular dystrophy after systemic phosphorodiamidate morpholino oligomer treatment: an open-label, phase 2, dose-escalation study Background We report clinical safety and biochemical efficacy from a dose-ranging study of i...
06\08\2011 - Teplizumab for treatment of type 1 diabetes

Teplizumab for treatment of type 1 diabetes (Protégé study): 1-year results from a randomised, placebo-controlled trial Background Findings of small studies have suggested that short treatments with anti-CD3 monoclonal antibodies that are mutated to reduce Fc receptor binding ...
30\07\2011 - Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes

Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled trial Background The immunopathogenesis of type 1 diabetes mellitus is associated with T-cell autoimmunity. To be fully active, immune T cells need a co-s...
23\07\2011 - Prednisone versus tamoxifen in patients with idiopathic retroperitoneal fibrosis

Prednisone versus tamoxifen in patients with idiopathic retroperitoneal fibrosis: an open-label randomised controlled trial Background Glucocorticoids are the mainstay of treatment of idiopathic retroperitoneal fibrosis, but they often have substantial toxic effects. Several reports have su...
16\07\2011 - Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO)

Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO): a phase 3 randomised double-blind active-controlled trial Background Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for ...
09\07\2011 - Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes

Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: the Early ACTID randomised controlled trial Background Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus, but no large trials have c...
02\07\2011 - Outpatient versus inpatient treatment for patients with acute pulmonary embolism

Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial Background Although practice guidelines recommend outpatient care for selected, haemodynamically stable patients with pulmonary embolism, most t...
25\06\2011 - The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease

The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial Background Lowering LDL cholesterol with statin regimens reduces the risk of myocardial infarction, ...
18\06\2011 - Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer

Addition of cetuximab to oxaliplatin-based first-line combination chemotherapy for treatment of advanced colorectal cancer: results of the randomised phase 3 MRC COIN trial Background In the Medical Research Council (MRC) COIN trial, the epidermal growth factor receptor (EGFR)-targeted ant...
11\06\2011 - Dexamethasone and length of hospital stay in patients with community-acquired pneumonia

Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial Background Whether addition of corticosteroids to antibiotic treatment benefits patients with community-acquired pneumonia who are not in intensive ...
04\06\2011 - Effect of fibroblast growth factor NV1FGF on amputation and death

Effect of fibroblast growth factor NV1FGF on amputation and death: a randomised placebo-controlled trial of gene therapy in critical limb ischaemia Background Patients with critical limb ischaemia have a high rate of amputation and mortality. We tested the hypothesis that non-viral 1 fibro...
14\05\2011 - Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms

Hydrogel-coated coils versus bare platinum coils for the endovascular treatment of intracranial aneurysms (HELPS): a randomised controlled trial Background Coated coils for endovascular treatment of cerebral aneurysm were developed to reduce recurrence and retreatment rates, and have been ...
30\04\2011 - Injectable extended-release naltrexone for opioid dependence

Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial Background Opioid dependence is associated with low rates of treatment-seeking, poor adherence to treatment, frequent relapse, and major societal consequences. We a...
05\03\2011 - Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer

Denosumab versus zoledronic acid for treatment of bone metastases in men with castration-resistant prostate cancer: a randomised, double-blind study Background Bone metastases are a major burden in men with advanced prostate cancer. We compared denosumab, a human monoclonal antibody agains...
19\02\2011 - Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma

Use of beclomethasone dipropionate as rescue treatment for children with mild persistent asthma (TREXA): a randomised, double-blind, placebo-controlled trial Background Daily inhaled corticosteroids are an effective treatment for mild persistent asthma, but some children have exacerbations...
15\01\2011 - High-dose vitamin D3 during intensive-phase antimicrobial treatment of pulmonary tuberculosis

High-dose vitamin D3 during intensive-phase antimicrobial treatment of pulmonary tuberculosis: a double-blind randomised controlled trial Background Vitamin D was used to treat tuberculosis in the pre-antibiotic era, and its metabolites induce antimycobacterial immunity in vitro. Clinical tr...
04\12\2010 - Renal sympathetic denervation in patients with treatment-resistant hypertension

Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial Background Activation of renal sympathetic nerves is key to pathogenesis of essential hypertension. We aimed to assess effectiveness and safety of ca...
20\11\2010 - Long-term effect of aspirin on colorectal cancer incidence and mortality

Long-term effect of aspirin on colorectal cancer incidence and mortality: 20-year follow-up of five randomised trials Background High-dose aspirin (≥500 mg daily) reduces long-term incidence of colorectal cancer, but adverse effects might limit its potential for long-term prevention. The...
09\10\2010 - Oral sucrose as an analgesic drug for procedural pain in newborn infants

Oral sucrose as an analgesic drug for procedural pain in newborn infants: a randomised controlled trial Background Many infants admitted to hospital undergo repeated invasive procedures. Oral sucrose is frequently given to relieve procedural pain in neonates on the basis of its effect on be...
11\09\2010 - Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults

Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial Background Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to a...
07\08\2010 - Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes

Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial Background Hyperglycaemia is associated with increased risk of cardiovascular complications in people with type 2 diabetes. We investigated whether reduc...
10\07\2010 - Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer

Background After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compar...
01\06\2010 - Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer

Background Colorectal cancer is the third most common cancer worldwide and has a high mortality rate. We tested the hypothesis that only one flexible sigmoidoscopy screening between 55 and 64 years of age can substantially reduce colorectal cancer incidence and mortality. Methods This randomi...
11\04\2010 - Survival as a function of HbA1c in people with type 2 diabetes: a retrospective cohort study

Background Results of intervention studies in patients with type 2 diabetes have led to concerns about the safety of aiming for normal blood glucose concentrations. We assessed survival as a function of HbA1c in people with type 2 diabetes. Methods Two cohorts of patients aged 50 years and ol...

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