Search results for "Interim"
showing 10 items of 95 documents
Early discharge and home treatment of patients with low-risk pulmonary embolism with the oral factor Xa inhibitor rivaroxaban: an international multi…
2020
Abstract Aims To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. Methods and results We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was sympto…
Single shot spinal anaesthesia with hypobaric bupivacaine for hip fracture repair surgery in the elderly. Randomized, double blinded comparison of 3.…
2014
Arterial hypotension is the most frequent adverse effect of subarachnoid anaesthesia in the elderly sustaining a femoral proximal fracture. Decreasing the local anaesthetic dose reduces the incidence of hypotension but shortens sensory block duration that could be insufficient in some surgical procedures. Sensory block duration could be prolonged using hypobaric local anaesthetics. We evaluated whether low hypobaric bupivacaine doses were adequate for this type of surgery while maintaining the haemodynamic stability.A prospective, randomized, double blinded study was designed. Patients over 65 years old, sustaining traumatic hip fracture, were assigned to one of two groups: B0.5 group, hypo…
Early switch to oral anticoagulation in patients with acute intermediate-risk pulmonary embolism (PEITHO-2) : a multinational, multicentre, single-ar…
2021
BACKGROUND: Current guidelines recommend a risk-adjusted treatment strategy for the management of acute pulmonary embolism. This is a particular patient category for whom optimal treatment (anticoagulant treatment, reperfusion strategies, and duration of hospitalisation) is currently unknown. We investigated whether treatment of acute intermediate-risk pulmonary embolism with parenteral anticoagulation for a short period of 72 h, followed by a switch to a direct oral anticoagulant (dabigatran), is effective and safe. METHODS: We did a multinational, multicentre, single-arm, phase 4 trial at 42 hospitals in Austria, Belgium, France, Germany, Italy, Netherlands, Romania, Slovenia, and Spain. …
Complete long-term survival data from a trial of adjuvant chemotherapy vs control after radical cystectomy for locally advanced bladder cancer.
2005
OBJECTIVES To report the long-term follow-up of patients with locally advanced bladder cancer treated with either adjuvant combined chemotherapy with methotrexate, vinblastine, doxorubicin/epirubicin, and cisplatin (MVAC/MVEC) or no additional treatment after radical cystectomy, to examine various survival endpoints and factors associated with long-term survival. PATIENTS AND METHODS Between May 1987 and December 1990, 49 patients undergoing radical cystectomy for locally advanced bladder cancer were randomized to observation only or adjuvant systemic chemotherapy with three cycles of MVAC/MVEC (methotrexate 30 mg/m2 on day 1, 15 and 22; vinblastine 3 mg/m2 on day 2, 15 and 22; doxorubicin …
EP46* First pass effect and associated clot characteristics in the EXCELLENT registry – Interim analysis
2021
Introduction EXCELLENT (NCT03685578) is a prospective, single-arm, multicenter, real-world international registry of mechanical thrombectomy (MT) for stroke with the EmboTrap device as first line treatment. The study entails thrombus analysis of specimens collected with each MT pass. Aim of the Study To compare rates of mRS 0–2 at 90 days and clot characteristics in subjects with and without first pass effect (FPE). Methods FPE was defined as mTICI 2c/3 after one pass and non-FPE as mTICI 2c/3 after >1 pass as adjudicated by an independent core lab. Clot analysis was performed by independent central labs blinded to clinical data. mRS at 90 days was scored by investigators blinded to procedu…
Matched-pairs analysis of outcomes with bortezomib, melphalan, and prednisone (VMP) treatment for previously untreated multiple myeloma (MM) using lo…
2015
(95% CI: 58-88%), respectively. A formal interim analysis of the Day 90 CR rate was conducted when 65 patients were evaluable, and at that time the Mel only arm was determined to be superior. The study was, therefore, stopped early by the Institutional DSMB. However, with a longer follow up Bu-Mel ultimately resulted in better PFS. Conclusions: Bu-Mel was associated with a significantly lower day 90 CR rate and a significantly higher rate of grade 3-4 non-hematologic toxicity, compared to Mel. However, after a median follow up of 15.7 months, PFS was significantly longer in the Bu-Mel arm. Figure 1 PFS from Day 90 by Treatment Arm
Allogeneic Stem Cell Transplant Versus Tandem High-Dose Melphalan for Front-Line Treatment of Deletion 13q14 Myeloma – An Interim Analysis of the Ger…
2009
Abstract Abstract 51 Background Allogeneic stem cell transplantation (allo SCT), a treatment modality based on transfer of immunocompetent donor lymphocytes offers curative potential to subjects with a variety of hematological cancers. In multiple myeloma (MM), high-dose melphalan followed by autologous stem cell transplantation (auto SCT) is adopted as a standard of care. However, it remains palliative since virtually all patients (pts) relapse and renders allo SCT an option of interest. Deletion of chromosome 13q14 (13q-) in MM has been shown to negatively impact prognosis. Therefore, improvement of therapy for 13q- pts is highly desirable. Patients and methods A prospective two-arm multi…
‘Stars’ or ‘professionals’: the imagined vocation and exclusive knowledge of translators in Israel
2010
Amb l’examen de la professionalització suspesa de l’ocupació traductora a Israel, aquest article estudia dos tipus de discursos d’autopresentació i estratègies d’estatus: d’una banda, els dels traductors literaris, i de l’altra, els dels traductors tècnics, subtituladors i traductors literaris que no pertanyen a l’elit. L’anàlisi del primer grup es fonamenta en diversos centenars d’articles retrat i altres reportatges en els mitjans de comunicació, que situen en primer pla 23 traductors reconeguts, mentre que la del segon grup es basa en resultats provisionals d’entrevistes obertes amb 22 treballadors de la traducció no pertanyents a l’elit (seleccionats a partir d’una mostra més àmplia reu…
Subcutaneous trastuzumab therapy for HER2-positive early breast cancer in the routine clinical practice: First interim analysis of the National Non-I…
2016
581Background: In 2013 a subcutaneous (SC) formulation of trastuzumab (T) was approved based on non-inferiority to intravenous (IV) T as proven in the HannaH trial. So far no data from the routine ...
Quality of Life Analysis of TORCH, a Randomized Trial Testing First-Line Erlotinib Followed by Second-Line Cisplatin/Gemcitabine Chemotherapy in Adva…
2012
INTRODUCTION:: The TORCH (Tarceva or Chemotherapy) trial randomized patients with advanced non-small-cell lung cancer to first-line erlotinib followed by second-line cisplatin/gemcitabine versus. standard inverse sequence. The trial, designed to test noninferiority in overall survival, was stopped at interim analysis because of inferior survival in the experimental arm. Quality of life (QoL), a secondary outcome, is reported here. METHODS:: QoL was assessed at baseline and every 3 weeks during first-line, using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 and QLQ-lung cancer specific module (LC13). Mean changes from baseline within arms …