scholarly journals Protocol Violation

2020 ◽  
Author(s):  
Keyword(s):  
Protocol Violation

Assessment of Response to Induction Therapy and Its Influence on 5-Year Failure-Free Survival in Group III Rhabdomyosarcoma: The Intergroup Rhabdomyosarcoma Study-IV Experience—A Report From the Soft Tissue Sarcoma Committee of the Children's Oncology Group

2007 ◽  
Vol 25 (31) ◽  
pp. 4909-4913 ◽  
Author(s):  
Megan Burke ◽  
James R. Anderson ◽  
Simon C. Kao ◽  
David Rodeberg ◽  
Stephen J. Qualman ◽  
...  
Keyword(s):  
Induction Chemotherapy ◽  
Induction Therapy ◽  
Response Rate ◽  
Initial Response ◽  
Complete Response ◽  
Local Institutions ◽  
Protocol Violation ◽  
Free Survival ◽  
Entire Cohort ◽  
Group Iii

Purpose Initial response to induction chemotherapy predicts failure-free survival (FFS) in osteosarcoma and Ewing's sarcoma. For Intergroup Rhabdomyosarcoma Study (IRS) IV patients with group III rhabdomyosarcoma, we assessed whether reported response assessed by anatomic imaging at week 8 predicted FFS. Patients and Methods We studied 444 group III patients who received induction therapy, had response assessed at week 8 by anatomic imaging, and continued with protocol therapy. Induction chemotherapy was generally followed by radiation therapy (RT) starting after week 9. Response to induction therapy was determined at weeks 0 and 8. Local institutions coded response. Results Response rate for the entire cohort at week 8 was 77% (95% CI, 73% to 81%; complete response [CR], 21%; partial response [PR], 56%) but response had no influence on FFS (P = .57). Two hundred seventy-two patients received standard-timing RT at week 9 and thus only chemotherapy during induction. Response rate was 81% (95% CI, 76% to 86%; CR, 22%; PR, 59%). In these patients, response did not influence FFS except for those with alveolar histology. One hundred thirty-two other patients received chemotherapy and RT during induction (up-front RT). Response rate was 65% (95% CI, 57% to 73%; CR, 12%; PR, 53%), but response had no influence on FFS (P = .69). Forty patients received no RT at all (protocol violation) and response to induction therapy had no effect on FFS. Conclusion In IRS-IV, response rate to induction therapy was 77% in group III patients, was independent of histology, and had no influence on FFS overall.

Re- and Demineralization Characteristics of Enamel Depending on Baseline Mineral Loss and Lesion Depth in situ

2016 ◽  
Vol 50 (2) ◽  
pp. 141-150 ◽  
Author(s):  
Richard J. Wierichs ◽  
Julian Lausch ◽  
Hendrik Meyer-Lueckel ◽  
Marcella Esteves-Oliveira
Keyword(s):  
Negative Control ◽  
Pronounced Change ◽  
Protocol Violation ◽  
Lesion Depth ◽  
Treatment Groups ◽  
Before And After ◽  
Double Blinded ◽  
Bovine Enamel ◽  
Mineral Loss

Objectives: The aim of this double-blinded, randomized, cross-over in situ study was to evaluate the re- and demineralization characteristics of sound enamel as well as lowly and highly demineralized caries-like enamel lesions after the application of different fluoride compounds. Methods: In each of three experimental legs of 4 weeks, 21 participants wore intraoral mandibular appliances containing 4 bovine enamel specimens (2 lowly and 2 highly demineralized). Each specimen included one sound enamel and either one lowly demineralized (7 days, pH 4.95) or one highly demineralized (21 days, pH 4.95) lesion, and was positioned 1 mm below the acrylic under a plastic mesh. The three randomly allocated treatments (application only) included the following dentifrices: (1) 1,100 ppm F as NaF, (2) 1,100 ppm F as SnF2 and (3) 0 ppm F (fluoride-free) as negative control. Differences in integrated mineral loss (ΔΔZ) and lesion depth (ΔLD) were calculated between values before and after the in situ period using transversal microradiography. Results: Of the 21 participants, 6 did not complete the study and 2 were excluded due to protocol violation. Irrespectively of the treatment, higher baseline mineral loss and lesion depth led to a less pronounced change in mineral loss and lesion depth. Except for ΔΔZ of the dentifrice with 0 ppm F, sound surfaces showed significantly higher ΔΔZ and ΔLD values compared with lowly and highly demineralized lesions (p < 0.05, t test). Conclusion: Re- and demineralization characteristics of enamel depended directly on baseline mineral loss and lesion depth. Treatment groups should therefore be well balanced with respect to baseline mineral loss and lesion depth.

scholarly journals 54 Acute Blood Pressure Lowering in Spontaneous Acute Intra-cerebral Haemorrhage: A Re-audit in a Tertiary Referral Stroke Centre

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii17-iii65
Author(s):  
Erica Walsh ◽  
John McCabe ◽  
Sean Murphy ◽  
Dearbhla Kelly ◽  
Emer Nicholson ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Retrospective Chart Review ◽  
Heart Association ◽  
Cerebral Haemorrhage ◽  
Successful Implementation ◽  
Protocol Violation ◽  
Pressure Lowering ◽  
Haematoma Expansion ◽  
The Mean ◽  
Stroke Centre

Abstract Background Acute blood pressure (BP) lowering to a target of <150mmHg systolic improves outcomes in patients with acute spontaneous intra-cerebral haemorrhage (sICH). It is thought that the beneficial effect of BP-lowering in sICH is time-sensitive and mediated through the prevention of haematoma expansion. The American Heart Association guidelines state that BP lowering to <150 mmHg or lower is safe and can improve functional outcome. Our aim was to re-evaluate the performance of clinicians in meeting target SBP levels of <150mmHg in patients with acute sICH within 1 hour of presentation, following the introduction of a BP-lowering protocol in our centre. Methods We undertook a retrospective chart review of consecutive patients with an acute sICH admitted to our centre between September 2017 and May 2018. Any patient who did not receive active medical management from the outset of presentation due to immediate initiation of palliative measures were excluded. The time from presentation to target BP and BP measured at 1 hour were recorded. Any protocol violations were also documented Results 11 patients were included (mean age 77.5years, 55% female). The mean BP at presentation and 1 hour was 186/93mmHg and 161/93mmHg respectively. The median and mean times from presentation to first achieved target BP was 129 and 120minutes respectively. At least 1 protocol violation occurred in 66.6% of cases. The most common protocol violation was the failure to escalate to an intravenous infusion of a BP-lowering agent in a timely manner when bolus therapy had failed. Conclusion An introduction of a BP protocol for patients with an acute sICH did not improve performance on achieving rapid SBP-lowering to target levels of <150mmHg. Strategies to improve awareness of this protocol are required to improve adherence and its successful implementation.

Low-Dose Radiation Is Sufficient for the Noninvolved Extended-Field Treatment in Favorable Early-Stage Hodgkin’s Disease: Long-Term Results of a Randomized Trial of Radiotherapy Alone

2001 ◽  
Vol 19 (11) ◽  
pp. 2905-2914 ◽  
Author(s):  
Eckhart Dühmke ◽  
Jeremy Franklin ◽  
Michael Pfreundschuh ◽  
Susanne Sehlen ◽  
Norman Willich ◽  
...  
Keyword(s):  
Hodgkin's Disease ◽  
Early Stage ◽  
Hodgkin’S Disease ◽  
Survival Rates ◽  
Long Term Results ◽  
Good Survival ◽  
Protocol Violation ◽  
Extended Field ◽  
Splenic Disease

PURPOSE: To show that radiotherapy (RT) dose to the noninvolved extended field (EF) can be reduced without loss of efficacy in patients with early-stage Hodgkin’s disease (HD). PATIENTS AND METHODS: During 1988 to 1994, pathologically staged patients with stage I or II disease who were without risk factors (large mediastinal mass, extranodal lesions, massive splenic disease, elevated erythrocyte sedimentation rate, or three or more involved areas) were recruited from various centers. All patients received 40 Gy total fractionated dose to the involved field areas but were randomly assigned to receive either 40 Gy (arm A) or 30 Gy (arm B) total fractionated dose for the clinically noninvolved EF. No chemotherapy was given. RT films were prospectively reviewed for protocol violations and recurrences retrospectively related to the applied RT. RESULTS: Of 382 recruited patients, 376 were eligible for randomized comparison, 190 in arm A and 186 in arm B. Complete remission was attained in 98% of patients in each arm. With a median follow-up of 86 months, 7-year relapse-free survival (RFS) rates were 78% (arm A) and 83% (arm B) (P = .093). The upper 95% confidence limit for the possible inferiority of arm B in RFS was 4%. Corresponding overall survival rates were 91% (arm A) and 96% (arm B) (P = .16). The most common causes of death (n = 27) were cardiorespiratory disease/pulmonary embolisms (seven), second malignancy (six), and HD (five). Protocol violation was associated with significantly poorer RFS. Nonirradiated nodes were involved in 42 of 52 reviewed relapses, infield areas in 18, marginal areas in 17, and extranodal sites in 16. CONCLUSION: EF-RT alone attains good survival rates in favorable early-stage HD. The 30-Gy dose is adequate for clinically noninvolved areas. Protocol violation worsens the subsequent prognosis. Relapse patterns suggest that systemic therapy can reduce the 20% long-term relapse rate.

Integrating clinical pharmacy services into patient care in an early-phase clinical trial clinic.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18228-e18228
Author(s):  
Dazhi Liu ◽  
Thu Oanh Dang ◽  
Stephen Harnicar ◽  
Katherine Kargus ◽  
Lauren A Evans ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supportive Care ◽  
Clinical Pharmacist ◽  
Early Phase ◽  
Treatment Options ◽  
Cancer Center ◽  
Protocol Violation ◽  
Patients With Cancer ◽  
The Impact

e18228 Background: Early phase clinical trials have broadened treatment options for patients with cancer. Expert management of these new therapies is essential to positive patient outcomes. At Memorial Sloan Kettering Cancer Center, the Developmental Therapeutic Center (DTC) satisfies this need. Oncology clinical pharmacists collaborate with other healthcare professionals to maximize the benefits of drug therapy and minimize toxicities. The purpose of this project is to describe the interventions from a clinical pharmacist assigned to the DTC. Methods: A clinical pharmacist joined DTC to serve adult patients with cancer undergoing clinical trials. The clinical pharmacist acted as a liaison between pharmacy team and medical team, and sees patients during their trial eligibility screening and follow-up visits. The interventions were documented by the clinical pharmacist in patients’ medical charts and email communications. All interventions during 1 month were retrospectively collected and categorized into supportive care optimization, protocol violation prevention, and operational. Results: The oncology clinical pharmacist was involved in 115 patient visits for trial eligibility screening or protocol follow-up. A total of 769 interventions were addressed including supportive care optimization (40.2%), protocol violation prevention (24.7%), and operational (35.1%). Conclusions: The oncology clinical pharmacist is actively engaged in many aspects of cancer care at the early phase trial clinic. Our results demonstrate the vital role of an oncology clinical pharmacist. The impact of these categorized intervention areas would require a formal outcome and cost-saving analysis. [Table: see text]

scholarly journals Clinical care or protocol violation?

Lab Animal ◽  
2009 ◽  
Vol 38 (1) ◽  
pp. 6-6
Author(s):  
Jerald Silverman
Keyword(s):  
Clinical Care ◽  
Protocol Violation

scholarly journals Pig Surgery: Can Reduction Be a Protocol Violation?

Lab Animal ◽  
2004 ◽  
Vol 33 (6) ◽  
pp. 14-14
Author(s):  
Jerald Silverman
Keyword(s):  
Protocol Violation

Abstract 4038: Prediction of Outcome After Cardiac Arrest and Induced Hypothermia

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Hans Friberg ◽  
Malin Rundgren
Keyword(s):  
Cardiac Arrest ◽  
Treatment Option ◽  
Neurological Examination ◽  
Monitoring And Evaluation ◽  
Level Of Care ◽  
Induced Hypothermia ◽  
Prediction Of Outcome ◽  
Protocol Violation ◽  
Initial Rhythm ◽  
Late Recovery

Prediction of outcome in comatose survivors after cardiac arrest is difficult and is further complicated with the introduction of hypothermia as a treatment option, since sedation and intermittent use of paralyzers are mandated. Other means of prognostication, unaffected by pharmaceuticals, are warranted. We present data from a coma project, where the aim was to evaluate prognostic means by themselves or in combination. All patients included to hypothermia treatment after cardiac arrest, independent of the initial rhythm or the location of arrest, were included. A standardised protocol for monitoring and evaluation of neurological function and outcome was used (Fig 1 ). Patients were assessed at 72 h after normothermia, at which time a decision on level of care was taken. During a four-year period, 106 consecutive patients were included; 19 were excluded because of death prior to evaluation (15), protocol violation (3) and intracerebral bleeding (1). Of the remaining 87 patients, 50 patients regained consciousness within 72 h after normothermia and 37 patients were still in coma (GCS≤7). Among these 37 patients, 8 patients eventually regained consciousness, whereas 29 did not. Our 8 patients with a late recovery had a positive profile regarding aEEG (continuous pattern), NSE (<27 ug/L at 48 h) and SSEP (cortical response), whereas 27 of 29 patients with persisting coma had at least one other strong marker for a bad outcome. A decision on level of care after cardiac arrest should be based on a neurological examination (GCS≤7) and at least one other prognostic tool. This should be performed no earlier than 72 h after normothermia. Fig 1:

MODELLING OF AN INTRUSION DETECTION SYSTEM USING C4.5 MACHINE LEARNING ALGORITHM

2021 ◽  
Vol 4 (4) ◽  
pp. 454-459
Author(s):  
Oyenike Mary Olanrewaju ◽  
Faith Oluwatosin Echobu ◽  
Abubakar Mogaji
Keyword(s):  
Intrusion Detection ◽  
Security Policy ◽  
Learning Algorithm ◽  
Detection System ◽  
Knowledge Discovery In Databases ◽  
Protocol Violation ◽  
Detection Model ◽  
Software Applications ◽  
Detection Systems ◽  
Proposed Model

The increasing growth of wireless networking and new mobile computing devices has caused boundaries between trusted and malicious users to be blurred. The shift in security priorities from the network perimeter to information protection and user resources security is an open area for research which is concerned with the protection of user information’s confidentiality, integrity and availability. Intrusion detection systems are programs or software applications embedded in sophisticated devices to monitor the activities on networks or systems for security, policy or protocol violation or malicious activities detection. In this work, an intrusion detection model was proposed using C4.5 algorithm which was implemented with WEKA tool and RAPID MINER. The model showed good performance when trained and tested with validation techniques. Implementation of the proposed model was conducted on the Network Security Laboratory Knowledge Discovery in Databases (NSL-KDD) dataset, an improved version of KDD 99 dataset, which showed that the proposed model approach has an average detection rate of 99.62% and reduced false alarm rate of 0.38%.

Up-Front Window Trial of Gemtuzumab Ozogamicin (GO) in Previously Untreated Elderly Patients with AML: An EORTC Leukemia Group Study.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 877-877 ◽  
Author(s):  
Sergio Amadori ◽  
S. Suciu ◽  
R. Willemze ◽  
F. Mandelli ◽  
D. Selleslag ◽  
...  
Keyword(s):  
Complete Remission ◽  
Standard Dose ◽  
Single Agent ◽  
Disease Free Survival ◽  
Gemtuzumab Ozogamicin ◽  
Remission Induction ◽  
Significant Activity ◽  
Conventional Chemotherapy ◽  
Platelet Recovery ◽  
Protocol Violation

Abstract Gemtuzumab ozogamicin, a conjugate of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic antibiotic calicheamicin, has shown significant antileukemic activity in relapsed AML with a favorable toxicity profile. The EORTC-LG performed a phase II study to investigate the activity and toxicity of GO used alone and in combination with conventional chemotherapy for remission induction in medically fit elderly pts (age between 61 and 75 years; WHO PS 0-1) with untreated AML. GO was administered iv over 2 hrs at the FDA-approved dose of 9 mg/m2. A second dose was given on day 15 in the absence of progressive disease or excessive toxicity and response was assessed four weeks later. This was to be followed by a course of conventional chemotherapy with mitoxantrone, cytarabine and etoposide (MICE regimen) and no further treatment in complete responders. Between 09/00 and 10/01 64 pts were enrolled , 57 of whom were evaluable for response and toxicity. The median age was 68 yrs (range 61–73); 43 pts had primary AML; CD33 positivity (≥20% marrow blasts) was documented in 44 pts (85%). GO therapy was completed by 47 of the 57 pts (82%): primary reasons 10 pts did not receive the scheduled second dose were disease progression (4), early death (2), toxicity (2) and protocol violation (2). The rate of initial response to GO was 35.1% (95% CI, 22.9%–48.9%) with 13 pts achieving complete remission (CR) and 7 CRp (complete remission with incomplete platelet recovery); 6 additional pts entered partial remission (PR). There were 3 (5.3%) toxic deaths (1 ARDS, 1 VOD, 1 infection) and 28 pts had resistant disease. Severe myelosuppression was the primary toxicity to GO. Grade 3 or 4 non-hematologic toxicities in more than 5% of pts during GO therapy included febrile neutropenia (39%), infection (28%), elevations of bilirubin, SGPT and creatinine of 8%, 6% and 6%, respectively. A clinical picture compatible with hepatic VOD developed in 3 pts (5%) resulting in 2 deaths (1 early, 1 in CRp). No baseline characteristics predicted for response to GO, but pts expressing CD33 in >80% marrow blasts tended to respond more favourably to the immunoconjugate (CR+CRp 7/14, 50%). Altogether, 51 pts survived GO therapy and 38 of them (75%) went on to receive a course of MICE after a median interval of 49 days (range 12–77) from the first dose of GO. Excessive toxicity (11 pts), protocol violation (1 pt) and treatment refusal (1 pt) were the main reasons for not starting chemotherapy. The ultimate best response rate was 54.4% (31/57; CR 35.1% and CRp 19.3%) increasing up to 65.8% among the 38 pts who were able to complete the whole induction sequence. Five pts died of toxicity during the MICE segment (2 VOD, 1 infection, 1 heart failure, 1 multi-organ failure) for an overall treatment related mortality of 14.1% (8/57). With a median follow-up of 3 yrs, 2-year overall survival (OS) and disease-free survival (DFS) estimates were 11.0% (SE=4.1%) and 12.1% (SE=3.5%), respectively. We conclude that: 1) single agent, standard dose GO has significant activity in untreated AML of the elderly with an acceptable safety profile; 2) sequential combination with standard chemotherapy is feasible and may improve treatment outcome in this poor risk disease, but myelotoxicity and liver dysfunction are of concern. An ongoing randomized trial will determine the contribution of GO given at reduced dose (6 mg/m2) to the observed antileukemic effect and toxicity.

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