Search results for "Randomized"
showing 10 items of 2323 documents
12-month follow-up analysis of a multicenter, randomized, prospective trial in de novo liver transplant recipients (LIS2T) comparing cyclosporine mic…
2006
The LIS2T study was an open-label, multicenter study in which recipients of a primary liver transplant were randomized to cyclosporine microemulsion (CsA-ME) (Neoral) (n = 250) (monitoring of blood concentration at 2 hours postdose) C2 or tacrolimus (n = 245) (monitoring of trough drug blood level [predose]) C0 to compare efficacy and safety at 3 and 6 months and to evaluate patient status at 12 months. All patients received steroids with or without azathioprine. At 12 months, 85% of CsA-ME patients and 86% of tacrolimus patients survived with a functioning graft (P not significant). Efficacy was similar in deceased- and living-donor recipients. Significantly fewer hepatitis C–positive pati…
Renal Function at Two Years in Liver Transplant Patients Receiving Everolimus: Results of a Randomized, Multicenter Study
2013
In a 24-month prospective, randomized, multicenter, open-label study, de novo liver transplant patients were randomized at 30 days to everolimus (EVR) + Reduced tacrolimus (TAC; n = 245), TAC Control (n = 243) or TAC Elimination (n = 231). Randomization to TAC Elimination was stopped prematurely due to a significantly higher rate of treated biopsy-proven acute rejection (tBPAR). The incidence of the primary efficacy endpoint, composite efficacy failure rate of tBPAR, graft loss or death postrandomization was similar with EVR + Reduced TAC (10.3%) or TAC Control (12.5%) at month 24 (difference -2.2%, 97.5% confidence interval [CI] -8.8%, 4.4%). BPAR was less frequent in the EVR + Reduced TAC…
Corticosteroid-free immunosuppression in liver transplantation: a meta-analysis and meta-regression of outcomes.
2009
To examine the impact of steroid withdrawal from the immunosuppression protocols in liver transplantation. The electronic databases Medline, Embase, Pubmed and the Cochrane Library were searched. Meta-analysis pooled the effects of outcomes of a total of 2590 patients enrolled into 21 randomized controlled trials (RCTs), using classic and modern meta-analytic methods. Meta-analysis of RCTs addressing patients transplanted for any indication showed no differences between corticosteroid-free immunosuppression and steroid-based protocols in most of the analyzed outcomes. More importantly, steroid-free cohorts appeared to benefit in terms of de novo diabetes mellitus development [R.R = 1.86 (1.…
Assessing the effectiveness of a game‐based phonics intervention for first and second grade English language learners in India: A randomized controll…
2021
Background In 2018, it was found that only a quarter of Grade 3 children in India were reading at grade level. A growing demand for English education has further limited children's literacy achievement. Despite a strong evidence base in favour of using systematic phonics for building English literacy skills, many teachers in India continue to use rote-methods of literacy instruction. Objectives We aimed to examine the efficacy of GraphoLearn (GL) English Rime, a computer-assisted reading intervention, in improving the foundational literacy skills of 1st and 2nd grade students who were attending an English medium school in India. Methods A total of 136 students across 6 classrooms were rando…
Arc crossing minimization in graphs with GRASP
2001
Graphs are commonly used to represent information in many fields of science and engineering. Automatic drawing tools generate comprehensible graphs from data, taking into account a variety of properties, enabling users to see important relationships in the data. The goal of limiting the number of arc crossings is a well-admitted criterion for a good drawing. In this paper, we present a Greedy Randomized Adaptive Search Procedure (GRASP) for the problem of minimizing arc crossings in graphs. Computational experiments with 200 graphs with up to 350 vertices are presented to assess the merit of the method. We show that simple heuristics are very fast but result in inferior solutions, while hig…
Lärm auf der Neugeborenen-Intensivstation: randomisierte Studie zum Einfluss eines Gehörschutzes auf intermittierende Hypoxien und Bradykardien
2015
Hintergrund: Atemregulationsstorungen Fruhgeborener, die mit Hypoxie und Bradykardie einhergehen, sind ein haufiges Problem mit unvollstandig verstandener Pathophysiologie. Unruhe des Kindes, z.T. durch Umgebungslarm ausgelost, ist moglicherweise ein Einflussfaktor. Wir wollten wissen, ob ein Gehorschutz die Haufigkeit von Hypoxien bei Fruhgeborenen mindestens halbiert. Patienten und Methoden: In einer randomisiert-kontrollierten Interventionsstudie mit Cross-Over Design wurde bei 31 Fruhgeborenen (14 mannlich; mittleres [min.-max.] Geburtsgewicht und Gestationsalter: 1 323 g [560–1 990] und 301/7 Wochen [255/7–330/7]) der Effekt eines Gehorschutzes auf die Haufigkeit von Sauerstoffentsatti…
Final results of OV16, a phase III randomized study of sequential cisplatin-topotecan and carboplatin-paclitaxel (CP) versus CP in first-line chemoth…
2013
5502 Background: Topotecan was evaluated in a novel combination regimen in comparison to standard therapy in front-line EOC. Methods: Women with newly diagnosed advanced EOC stages IIB-IV, ECOG performance status (PS) 0-1, age < 75, were randomized to either Arm 1: cycles 1 - 4: cisplatin 50 mg/m2 d1 plus topotecan 0.75 mg/m2 d1-5 IV; cycles 5 - 8: paclitaxel 175 mg/m2over 3 hrs d1 followed by carboplatin AUC5 day 1 or Arm 2: paclitaxel plus carboplatin as in Arm 1 for 8 cycles. The primary endpoint was progression free survival (PFS) and secondary endpoints included objective response, overall survival (OS), adverse event (AE) and Quality of Life (QoL). The sample size required 800 pts…
Outcome Prediction in Node-Negative Breast Cancer Based on ASCO-Recommended Biomarkers uPA/PAI-1 Using the Final 10-Year Analysis of the Randomized M…
2009
Abstract Background: Based on interim analysis of Chemo N0, the first prospective multicenter randomized clinical trial using biomarkers uPA/PAI-1 for risk stratification and chemotherapy selection in N0 breast cancer, uPA/PAI-1 are now recommended for routine use by ASCO and AGO guidelines. Final 10-year follow-up of Chemo N0 has validated the clinically relevant long-term prognostic and predictive impact of uPA/PAI-1 in N0 breast cancer. To quantify the clinical utility of this impact, outcomes in subgroups defined by these biomarkers were compared to predictions of Adjuvant Online™, the leading validated tool based on established clinical factors. Methods: In Chemo N0, patients (n=647, 1…
Optimizing prostate cancer screening; prospective randomized controlled study of the role of PSA and PCA3 testing in a sequential manner in an opport…
2014
Abstract Objectives To reduce unnecessary biopsies (Bx) in an opportunistic screening programme of prostate cancer. Material and methods We performed a prospective evaluation of PCA3 as a second-line biomarker in an opportunistic screening for prostate cancer (PCa). From September 2010 until September 2012, 2,366 men, aged 40–74 years and with >10 years life expectancy, were initially screened with PSA/digital rectal examination (DRE). Men with previous Bx or with recent urine infections were excluded. Men with abnormal DRE and/or PSA > 3 ng/ml were submitted for PCA3. All men with PCA3 ≥ 35 underwent an initial biopsy (IBx) —12cores—. Men with PCA3 .5 ng/ml at 4-6months or PSAv > .75 ng/…
[Evidence-based emergency medicine].
1999
„Evidence Based Emergency Medicine” (EBEM) ist ein Begriff, der im Zusammenhang mit Qualitatsmanagement immer haufiger verwendet wird. Er soll letztlich zum Ausdruck bringen, das Effektivitat und Effizienz von Methoden, Verfahren, Medikationen etc. – wo immer moglich – durch wissenschaftliche Beweise (erhoben in kontrollierten Studien oder abgeleitet aus Metaanalysen, aber auch beruhend auf „State of the Art Reviews”) belegt werden mussen, bevor sie in die arztliche Praxis umgesetzt werden.Wo dies nicht oder nicht mehr moglich ist, mus versucht werden, die zugrundeliegenden diagnostischen und therapeutischen Prinzipien im Nachhinein zu validieren. Nur so kann die Lucke zwischen Forschung ei…