Search results for "Placebo-controlled study"

Epidural anesthesia: Simulated intravascular test dose with S(+) ketamine, lidocaine and adrenaline. A prospective, randomized, double blind and plac…

2015

Abstract Objective The use of a test dose in epidural anesthesia is a safety recommendation. However, specificity and sensitivity of the drugs used with this indication have not been conclusive. The main objective of this study was to compare the effectiveness and the adverse effects of a simulated intravascular test dose of adrenaline, lidocaine and S(+)-ketamine. Material and methods A prospective, randomized, double blinded, placebo controlled study was designed. ASA I patients scheduled for elective surgery were included. These were randomized to the following study groups: S(+)-ketamine 0.5 mg kg −1 (S+K group), 5% lidocaine 1.5 mg kg −1 (L5% group), adrenaline 15 μg (ADR group), and p…

Repercussions of intraalveolar placement of combination of 0.2% chlorhexidine & 10 Mg metronidazole gel on the occurrence of dry sockets- A randomize…

2017

BACKGROUND To evaluate the effects of intraalveolar placement of gel containing 0.2% chlorhexidine and 10gm of metronidazole on the incidence of alveolar osteitis. MATERIAL AND METHODS A total of 300 impacted third molars were extracted in 150 patients enrolled in this trial. In each subject a socket was randomly selected and packed to the crest of alveolar ridge with the gel. The contralateral socket was packed with placebo dressing. The occurrence of dry socket was assessed during 3rd and 5th postoperative days .The data was analysed using a meta analytical program. STUDY DESIGN Double blind, prospective, placebo controlled trial. RESULTS The combination of metronidazole + chlorhexidine g…

A multi-national, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of BMN 110 treatment for mucopolysaccharidos…

2013

Lapatinib in combination with ECF/x in EGFR1 positive first-line metastatic gastric cancer (GC): A phase II randomized placebo controlled trial (EORT…

2012

TPS4140 Background: Survival of HER2+ metastatic GC is prolonged by trastuzumab when administered with CF/X (VanCutsem, ASCO 2009). Lapatinib inhibits both EGFR1 and HER2, is active in HER2+ GC lines, and has shown clinical activity in uncontrolled phase II GC trials. A phase III trial of lapatinib with X + oxaliplatin in HER2+ (FISH) GC is closed to recruitment. Additional unaddressed questions include the efficacy and safety of lapatinib with ECF/X (epirubicin + cisplatin + 5-FU or capecitabine (X), which is a preferred chemotherapy (CT) regimen in GC), and its activity in patients (pts) with discordant FISH or IHC HER2 status or EGFR1+. Methods: This is a phase II, randomized, double- b…

GM-CSF in a Double-Blind Randomized Placebo-Controlled Trial in Therapy of Adult Patients with De Novo Acute Myeloid Leukemia

1994

Despite the fact that 60%–70% of patients with de novo acute myeloblastic leukemia (AML) achieve a complete remission (CR) of the disease only about 20%–30% of the patients remain in long term remission and are probably cured [1,2]. These rather disappointing long-term results argue in favor of an even more intensive induction and post-remission therapy. This intention is, however, at time limited by therapy associated toxicity. Especially haematotoxicity seems to be the limiting factor in that patients with profound neutropenia are at high risk of developing fatal infectious complications [3]. In this context haematopoietic growth factors, such as granulocyte-macrophage colony-stimulating …

ONCE-DAILY INDACATEROL PROVIDES SUPERIOR BRONCHODILATION, HEALTH STATUS AND CLINICAL OUTCOMES COMPARED WITH SALMETEROL IN PATIENTS WITH CHRONIC OBSTR…

2009

Moving from the Oslerian paradigm to the postgenomic era: Are asthma and COPD outdated terms?

2016

In the majority of cases, asthma and chronic obstructive pulmonary disease (COPD) are two clearly distinct disease entities. However, in some patients there may be significant overlap between the two conditions. This constitutes an important area of concern because these patients are generally excluded from randomised controlled trials (mostly because of smoking history in the case of asthma or because of significant bronchodilator reversibility in the case of COPD). As a result, their pathobiology, prognosis and response to therapy are largely unknown. This may lead to suboptimal management and can limit the development of more personalised therapeutic options. Emerging genetic and molecul…

Cancer prevention with aspirin in hereditary colorectal cancer (Lynch syndrome), 10-year follow-up and registry-based 20-year data in the CAPP2 study…

2020

BACKGROUND: Lynch syndrome is associated with an increased risk of colorectal cancer and with a broader spectrum of cancers, especially endometrial cancer. In 2011, our group reported long-term cancer outcomes (mean follow-up 55·7 months [SD 31·4]) for participants with Lynch syndrome enrolled into a randomised trial of daily aspirin versus placebo. This report completes the planned 10-year follow-up to allow a longer-term assessment of the effect of taking regular aspirin in this high-risk population.METHODS: In the double-blind, randomised CAPP2 trial, 861 patients from 43 international centres worldwide (707 [82%] from Europe, 112 [13%] from Australasia, 38 [4%] from Africa, and four [&l…

Impact of probiotic Saccharomyces boulardii on the gut microbiome composition in HIV-treated patients: A double-blind, randomised, placebo-controlled…

2017

Dysbalance in gut microbiota has been linked to increased microbial translocation, leading to chronic inflammation in HIV-patients, even under effective HAART. Moreover, microbial translocation is associated with insufficient reconstitution of CD4+T cells, and contributes to the pathogenesis of immunologic non-response. In a double-blind, randomised, placebo-controlled trial, we recently showed that, compared to placebo, 12 weeks treatment with probiotic Saccharomyces boulardii significantly reduced plasma levels of bacterial translocation (Lipopolysaccharide-binding protein or LBP) and systemic inflammation (IL-6) in 44 HIV virologically suppressed patients, half of whom (n = 22) had immun…

Effects of Caffeine as an Adjuvant to Morphine in Advanced Cancer Patients

2001

Psychomotor abnormalities are one of the complications of opioid therapy in advanced cancer patients. Caffeine has potential properties to counteract the central effects of morphine. Twelve patients receiving stable doses of slow release morphine with adequate pain relief were scheduled for this double-blind placebo-controlled crossover trial. The treatment consisted of an intravenous dose of 1/6 of the daily morphine dose, using an intravenous/oral conversion ratio of 1:3. The dose calculated was administered in 5 minutes. Patients were randomly divided to received in a double-blind manner an infusion of 200 mg of caffeine or saline solution intravenously over one hour. A crossover took pl…