Communications and Follow-Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Closing Conference, Final Report, and

2005 ◽  
pp. 49-52
Keyword(s):  
Final Report

scholarly journals CTNI-14. A 3-ARM, PHASE IIA TRIAL OF SAFETY & EFFICACY OF OLINVACIMAB, A MONOCLONAL ANTIBODY TO VEGFR2 IN PATIENTS WITH RECURRENT GLIOBLASTOMA MULTIFORME WITH IMAGING AND PK/PD ASSESSMENTS: FINAL REPORT

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii44-ii45
Author(s):  
Lawrence Cher ◽  
Anna Nowak ◽  
George Iatropoulos ◽  
Samantha Bowyer ◽  
Hui Gan ◽  
...  
Keyword(s):  
Recurrent Glioblastoma ◽  
Final Report ◽  
Recurrent Glioblastoma Multiforme ◽  
Open Label ◽  
Impaired Wound Healing ◽  
Significant Difference ◽  
Angiogenic Effect ◽  
Vegf Pathway ◽  
Recurrent Gbm

Abstract The VEGF pathway remains an important target in GBM given its vascularity and autocrine VEGF signalling. Olinvacimab (TTAC-0001) is a fully humanised VEGFR2 Mab that binds and inhibits the receptor. This report assesses the safety, dosing schedules and efficacy of Olinvacimab in recurrent GBM. We conducted a two-site, 3 arm, open-label study of Olinvacimab in recurrent GBM. Eligible patients were ≥18 years with RANO-measurable lesion, KPS ≥ 80, and had completed chemoradiotherapy without prior bevacizumab therapy. We assessed three arms, 8 mg/kg and 12mg/kg weekly for 3 of every 4 weeks, and 12 mg/kg weekly. Three patients were treated in arms 1 and 2 and 6 in arm 3. Safety assessments were performed prior to dose escalation. The main toxicity was development of grade 1 (67%) and 2 (8%%) cutaneous haemangiomas. Common toxicities seen with other VEGF directed therapies, including hypertension, impaired wound healing, and proteinuria were not seen in this cohort. Efficacy was assessed by MRI using RANO criteria. 6 month PFS was 17%, with disease control in 25%, with steroid dose reduction. The longest response was 15 months. On DCE MRI, there was no significant difference in perfusion parameters between baseline and 1st follow-up MRI comparing those with SD and PD. However, 6 of 12 patients showed decreased Ktrans > 20 % of baseline, consistent with an anti-angiogenic effect of Olinvacimab. Pharmacokinetics showed a decreased clearance rate and increased half-life of Olinvacimab compared to the prior Phase I study. Pharmacodynamic studies showed significantly higher levels of angiogenic markers, particularly VEGF-A in those treated at 12mg/kg vs arm 1. VEGF-A, C and D levels were elevated in patients with SD compared to those with PD. Conclusion: Olinvacimab was well tolerated with a different toxicity profile to other VEGFR directed therapies. There were promising responses in 25% of patients.

scholarly journals Ten-year analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial

2020 ◽  
Vol 132 (3) ◽  
pp. 771-776 ◽  
Author(s):  
Robert F. Spetzler ◽  
Cameron G. McDougall ◽  
Joseph M. Zabramski ◽  
Felipe C. Albuquerque ◽  
Nancy K. Hills ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Artery Aneurysm ◽  
Ruptured Aneurysm ◽  
Outcome Analysis ◽  
Final Report ◽  
Clinical Trial Registration ◽  
Poor Outcome ◽  
Significant Difference ◽  
Saccular Aneurysms

OBJECTIVEThe authors present the 10-year results of the Barrow Ruptured Aneurysm Trial (BRAT) for saccular aneurysms. The 1-, 3-, and 6-year results of the trial have been previously reported, as have the 6-year results with respect to saccular aneurysms. This final report comparing the safety and efficacy of clipping versus coiling is limited to an analysis of those patients presenting with subarachnoid hemorrhage (SAH) from a ruptured saccular aneurysm.METHODSIn the study, 362 patients had saccular aneurysms and were randomized equally to the clipping and the coiling cohorts (181 each). The primary outcome analysis was based on the assigned treatment group; poor outcome was defined as a modified Rankin Scale (mRS) score > 2 and was independently adjudicated. The extent of aneurysm obliteration was adjudicated by a nontreating neuroradiologist.RESULTSThere was no statistically significant difference in poor outcome (mRS score > 2) or deaths between these 2 treatment arms during the 10 years of follow-up. Of 178 clip-assigned patients with saccular aneurysms, 1 (< 1%) was crossed over to coiling, and 64 (36%) of the 178 coil-assigned patients were crossed over to clipping. After the initial hospitalization, 2 of 241 (0.8%) clipped saccular aneurysms and 23 of 115 (20%) coiled saccular aneurysms required retreatment (p < 0.001). At the 10-year follow-up, 93% (50/54) of the clipped aneurysms were completely obliterated, compared with only 22% (5/23) of the coiled aneurysms (p < 0.001). Two patients had documented rebleeding, both died, and both were in the assigned and treated coiled cohort (2/83); no patient in the clipped cohort (0/175) died (p = 0.04). In 1 of these 2 patients, the hemorrhage was not from the target aneurysm but from an incidental basilar artery aneurysm, which was coiled at the same time.CONCLUSIONSThere was no significant difference in clinical outcomes between the 2 assigned treatment groups as measured by mRS outcomes or deaths. Clinical outcomes in the patients with posterior circulation aneurysms were better in the coiling group at 1 year, but after 1 year this difference was no longer statistically significant. Rates of complete aneurysm obliteration and rates of retreatment favored patients who actually underwent clipping compared with those who underwent coiling.Clinical trial registration no.: NCT01593267 (clinicaltrials.gov)

scholarly journals Adaptation of Radiology Software to Improve Cardiology Results Reporting

2017 ◽  
Vol 08 (03) ◽  
pp. 936-944
Author(s):  
Kendra Ward ◽  
Barbara Deal ◽  
Jeffrey Anderson ◽  
Sabrina Tsao ◽  
Gregory Webster
Keyword(s):  
Pediatric Cardiology ◽  
Outcome Variable ◽  
Final Report ◽  
Post Intervention ◽  
Primary Outcome Variable ◽  
Holter Monitor ◽  
Scanning Time ◽  
Improve Result ◽  
Results Reporting

Summary Objective: Twenty-four hour ambulatory electrocardiograms (“Holter” monitors) are a key diagnostic test in cardiology. Commercial electronic medical record (EMR) tools have not been designed for pediatric Holter monitor reporting and paper-based methods are inefficient. Methods: Our tertiary pediatric hospital adapted a radiology EMR tool to a cardiology workflow in order to report Holter monitor results. A retrospective review was performed at 4 time points: prior to intervention, immediately post-intervention, at 6 months and at 12 months post-intervention. The primary outcome variable was time to reporting of Holter findings. Results: Holter reports were reviewed on 527 studies (patient ages: 1 day to 42 years). The time between the date the patient returned the Holter monitor until the date the referring physician received a final report improved from 19.8 days to 1.5 days (p<0.001). This result was durable over the next 12 months of follow-up. Physician interpretation time improved from 2.1 days to 0.6 days (p=0.01). Transcriptionist time and result scanning time were eliminated (removing 1.9 days and 14 days from the workflow, respectively). Conclusion: EMR systems are not typically designed for pediatric cardiology, but existing systems can be adapted, yielding important gains for patient care. In specialties like pediatric cardiology, there is insufficient volume nationally to drive development of commercial systems. This study demonstrates the general principle that creative adaptation of EMR systems can improve result reporting in pediatric cardiology and likely in other cardiology practices.Citation: Webster G, Ward K, Deal BJ, Anderson JB, Tsao S. Adaptation of Radiology Software to Improve Cardiology Results Reporting. Appl Clin Inform 2017; 8: 936–944 https://doi.org/10.4338/ACI-2017-03-RA-0051

scholarly journals VOICES: the value of 6-month clinical evaluation in stroke. The protocol for a planned qualitative study to ascertain the value of stroke follow-up to people affected by stroke

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006384 ◽  
Author(s):  
Colin Jenkins ◽  
Fiona Price
Keyword(s):  
Narrative Analysis ◽  
Care Pathway ◽  
Scientific Journal ◽  
Unmet Need ◽  
Stroke Care ◽  
Final Report ◽  
Stroke Survivors ◽  
Post Discharge ◽  
Semistructured Interviews

IntroductionThe National Clinical Guidelines for Stroke recommend ‘routine follow-up of patients 6 months post discharge’. The Sentinel Stroke National Audit Programme sets a standard of 6 months postadmission follow-up, capturing data on process and outcomes. There appears to be no convincing model of stroke follow-up at 6 months, and despite evidence of unmet need in almost 50% of stroke survivors 1–5 years after their stroke, little work focuses on the first 12 months of recovery. By listening to the living experiences of stroke, the research aims to tailor the stroke care pathway to the needs of those affected.Methods and analysisA focus group of six stroke survivors and carers will be invited to identify appropriate interview questions about the value of follow-up at 6 months, ensuring that this study has its genesis in the participant experience. A pilot study of four stroke survivors will ascertain the feasibility of the method. Thirty stroke survivors from the follow-up clinic will be invited to take part in semistructured interviews. Raw data, in the form of digital recordings of the interviews, will be transcribed. Interview transcriptions will be checked by the participant for accuracy prior to analysis using NVivo software. Literal and reflective narrative analysis will be used to code transcribed text to examine shared themes and reflect on content.Ethics and disseminationStudy documentation has been reviewed by the Coventry and Warwickshire Research Ethics Committee; the chief investigator met with the committee to scrutinise the study and justify its methodology. The committee has approved this study. A copy of the final report will be given to participants, the Stroke Association, the local Clinical Commissioning Group and participants’ general practitioners. It is intended to disseminate the results locally by presentation to the Trust board, at academic conferences and by publication in a peer-reviewed scientific journal.

Capturing skill in estimating training development effort: A follow-up final report

1988 ◽  
Vol 27 (9) ◽  
pp. 40-44
Author(s):  
Robert J. Casey ◽  
Roseann Mikos ◽  
Dennis J. Sullivan ◽  
Jeanne M. Hebein
Keyword(s):  
Final Report ◽  
Development Effort ◽  
Training Development

scholarly journals Zpráva o výsledcích Světové konference ke vzdělání pro udržitelný rozvoj uzavírající Dekádu UNESCO pro vzdělávání pro UR

Envigogika ◽  
2014 ◽  
Vol 9 (2) ◽  
Author(s):  
Jana Dlouhá
Keyword(s):  
Sustainable Development ◽  
Czech Republic ◽  
Education For Sustainable Development ◽  
Final Report ◽  
World Conference ◽  
The Czech Republic ◽  
Global Action ◽  
Action Programme

The article presents the results of the UNESCO World Conference on Education for Sustainable Development held in Nagoya, Japan, on 10-12 November 2014. The aim of the Conference was primarily to review the results of the Decade – the final report of the Decade, Shaping the Future We Want, was introduced in which the role of education as a tool for the overall transition towards sustainability was stressed. The Global Action Programme as a follow-up to the Decade was also introduced; commitment to implement it was accepted in the Aichi-Nagoya Declaration. The options for the Czech Republic to become involved in these international activities are briefly reviewed.

scholarly journals Capaian standar proses implementasi kurikulum 2013 (studi kasus pada SMA 1, SMA 2 dan SMA 5 sebagai sekolah piloting Kota Balikpapan)

2017 ◽  
Vol 5 (2) ◽  
pp. 130
Author(s):  
C Asmudi
Keyword(s):  
Learning Outcomes ◽  
Lesson Plan ◽  
Research Result ◽  
Study Data ◽  
Final Report ◽  
Assessment Of Learning ◽  
Principles Of Learning ◽  
Academic Interests ◽  
Data Subject

<p><em>This study aims to reveal: (1) process standard achievement (2) obstacles faced by schools (3) strategy to overcome obstacles in the implementation of Curriculum 2013. The method used in this research is qualitative method with observation approach, interview and document study. Data subject; Principals, Vice facility and Curriculum, subject teachers, students and parent representatives. Research result; (1) Principles of learning, (2) Learning Planning, (3) Lesson Plan, covering Introduction, core activities and closing (4) assessment of learning outcomes done with three domains, attitudes, knowledge, and skills of achievement are, (a) SMA N 5; 87.55 (b) SMA N 2; 88.88 and (c) SMA N 1; 94.44, (5) Supervision of learning outcomes is done in four steps; (a) Monitoring, this activity is carried out by the principal and supervisor of the supervisor in each school, (b) supervision of teachers in the class conducted by Subject supervisors, using the instrument, the results of class supervision prepared semester final report, the result of the average teacher is 7.8. Teachers with less than 70 supervision scores, follow-up step by giving specific guidance and priority supervision entry. Implications of implementation of process standards as piloting school drivers improve SKS program as a follow-up channel of optimization of learning process standards in channelling students' academic interests and talents accordingly with its characteristics.</em></p>

Improved Outcome with Pulses of Vincristine and Steroids in Continuation Therapy of Children with Average Risk Acute Lymphoblastic Leukemia (ALL) and Non Hodgkin Lymphoma (NHL): Final Report of the EORTC Randomized Phase III Trial 58951

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 11-11 ◽  
Author(s):  
Barbara De Moerloose ◽  
Stefan Suciu ◽  
Yves Bertrand ◽  
Francoise Mazingue ◽  
Alain Robert ◽  
...  
Keyword(s):  
Lymphoblastic Leukemia ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Final Report ◽  
Average Risk ◽  
Childhood All ◽  
Non Hodgkin Lymphoma ◽  
Continuation Therapy ◽  
The Impact

Abstract Background: An overview of trials dating back to the ‘70s and ‘80s has shown that addition of vincristine (VCR)+prednisone/prednisolone pulses to continuation therapy of childhood ALL, i.e. 6-mercaptopurine (6-MP) + methotrexate (MTX), improved disease-free survival (DFS) (Lancet, 1996). However, a recent randomized intergroup trial (IGT) has shown that, when given to intermediate risk (age&lt;1 or &gt;=6 yrs or WBC&gt;20×109/L) patients (pts) treated according to the BFM protocol, VCR+dexamethasone (DEX) pulses in continuation therapy failed to improve DFS and overall survival (Lancet, 2007). Methods: In 12/1998, EORTC CLG started the randomized phase III 58951 trial addressing 3 questions: R1) the value of DEX vs PRED in induction; R2) the value of prolonged (24 injections) vs conventional (12 injections) duration of L-asparaginase (ASPA) courses during consolidation and late intensification; R3) for average risk (AR) pts only: the value of 6 (VCR+corticosteroid) pulses every 10 weeks during continuation therapy. The corticoid of the pulses was that assigned to the patient at R1: DEX (6 mg/sm/d) or prednisolone (PRED) (60 mg/sm/d) during 7 days. AR pts were defined by being neither low risk (hyperploidy &gt; 50 or DNI&gt;1.16, and WBC&lt;10×109/L and no extramedullary involvement) nor very high risk (Leukemia 2000). A total of 81 pts from the EORTC 58951 trial were included in the IGT study. Randomization was done centrally, and the main endpoint was DFS; secondary endpoints were OS and toxicity. Intent-to-treat analysis was used. Results: Between 6.1999 and 11.2004, 411 pts, ALL (N=384) and NHL (N=27), were randomized for the pulse question. In the Pulses group, 101 vs 101 pts were randomized for PRED vs DEX. At a median follow-up of 6.3 years, there were 19 vs 34 DFS events for the Pulses vs No Pulses comparison: BM (10 vs 16), CNS only (1 vs 4), other isolated (2 vs 3), BM+CNS (2 vs 5), BM+other (4 vs 4), death in CR (0 vs 2). The 6-year DFS rate from randomization was 90.6% (SE 2.1%) in the Pulses group and 82.8% (SE 2.8%) in the No Pulses group (hazard ratio (HR) = 0.54, 95% CI 0.32–0.94, 2-sided logrank p=0.027). The impact of pulses on DFS was similar in the PRED group (HR=0.56) and the DEX group (HR=0.59). In girls the treatment difference seemed to be more pronounced (HR=0.25, 99% CI 0.04–1.25; p=0.015) than in boys (HR=0.71, 99% CI 0.30–1.66; p=0.30), and also in those having been randomized to receive conventional duration of ASPA courses (HR=0.46, 99% CI 0.18–1.19; p=0.03) than in prolonged ASPA arm (HR=0.87, 99% CI 0.23–3.29; p=0.78). Grade 3–4 hepatic toxicity was lower in the Pulses group (30% vs 40%); incidence of grade 2–3 osteonecrosis was 4.4% (Pulses) vs 2% (No Pulses) and pancreatitis rate was 4.9% (Pulses) vs 2.9% (No Pulses). Conclusion: VCR+corticosteroid pulses, at long follow-up (median=6.3 yrs), significantly improved the DFS, particularly in pts having received conventional duration of ASPA. Pulses did not increase toxic effects. In future, for AR pts treated according to the BFM protocol, pulses should become a standard component of therapy.

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