scholarly journals SURG-09. CHANGING PARADIGMS IN THE MANAGEMENT OF CEREBRAL METASTASES

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi241-vi241
Author(s):  
Edvin Telemi ◽  
James Snyder ◽  
Ian Lee ◽  
Adam Robin
Keyword(s):  
Disease Progression ◽  
Cause Of Death ◽  
Small Sample Size ◽  
Expectant Management ◽  
Initial Therapy ◽  
Small Sample ◽  
Cerebral Metastases ◽  
Extracranial Disease ◽  
The Mean ◽  
Clinically Significant

Abstract INTRODUCTION Paradigms in the management of cerebral metastases (CM) are evolving, in part due to the expanded use of laser interstitial thermal therapy or LITT in lesion ablation, with treatment of CM comprising up to 34% of all LITT cases. Currently, CM are treated with LITT largely in the setting of disease progression after initial therapy with focused radiation with no standard for performing biopsy prior to LITT. In this study we aim to assess the significance of the pathology of the lesion at the time of LITT on survival. METHODS We conducted a retrospective review of our institution’s LITT/brain tumor database and identified patients who underwent LITT with concurrent biopsy. For deceased patients, we identified cause of death if secondary to neurologic causes defined as death either due to direct intracranial disease progression leading to rapid neurologic decline or due to progressive neurologic decline without significant extracranial disease burden. RESULTS We identified 16 progressive CM lesions in 15 adults treated with LITT with concurrent biopsy, predominantly with non-small cell lung cancer. The mean age at LITT was 62, median follow-up was 8.5 months and thirteen of fifteen patients had previous focused radiation therapy. Eleven of sixteen lesions demonstrated radiation necrosis(RN) without tumor and 5 with tumor progression(TP). The mean survival in patients with RN was 548 days compared with 285 days in patients with TP (p=0.15). Of the 9 deceased, 2 of 5 patients with RN and 3 of 4 patients with TP died of neurologic causes. CONCLUSIONS Although statistically not significant due to the small sample size, this preliminary analysis suggests that clinically significant differences in survival and cause of death may exist between patients with RN and TP. Further evaluation with implications for treatment, prognosis and the expectant management of the patient with CM is warranted.

Salvage combination ipilimumab and nivolumab after failure of prior checkpoint inhibitor therapy in patients with advanced melanoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21009-e21009 ◽  
Author(s):  
Elizabeth Mary Gaughan ◽  
Gina R. Petroni ◽  
William W. Grosh ◽  
Craig L. Slingluff
Keyword(s):  
Combination Therapy ◽  
Small Sample Size ◽  
Objective Response ◽  
Initial Therapy ◽  
Subsequent Treatment ◽  
Advanced Melanoma ◽  
Small Sample ◽  
Treatment Naïve ◽  
Clinicopathologic Factors ◽  
Clinically Significant

e21009 Background: The combination of Ipilimumab and Nivolumab is standard initial therapy in patients with advanced melanoma based on trials involving treatment-naïve patients. The benefit in those previously managed with checkpoint monotherapy is not well defined. Methods: We identified metastatic melanoma patients from our Immunotherapy database managed with combination Ipilimumab/Nivolumab after progression on prior checkpoint monotherapy. Baseline clinical factors, treatment history, combination therapy outcome by RECIST v1.1 and toxicity data were collected. Descriptive statistics were used to summarize the data. Given the small sample size and limited numbers of deaths, it is too early to look for preliminary associations between outcomes and clinicopathologic factors. Results: We identified 19 patients treated with combination Ipilimumab/Nivolumab after progression on prior checkpoint monotherapy. The cohort included 15 men and 4 women with an average age of 63 years. Thirteen patients had M1c disease, and 7 had a BRAF mutation. Patients had received up to four lines of prior immunotherapy including 9 treated with both prior anti-PD1 and anti-CTLA4 monotherapy. Seven patients completed all four doses of combination therapy with 6 proceeding onto maintenance nivolumab. Eight patients stopped treatment due to toxicity and 4 due to progressive disease. Thirteen patients had clinically significant toxicity, with rash, colitis, hepatitis, and hypophysitis reported most frequently. There were no treatment-related deaths. Overall, 2/19 patients (10.5%, 95% CI [1.3% to 33.1%]) had an objective response (CR+PR) and 9/19 patients (47.4%, 95% CI [24.5% to 71.1%]) had disease control (CR+PR+SD). Four of the patients had stable disease for over 6 months. Six of the 19 patients went on to receive subsequent treatment. Median follow-up for patients still alive was 7 months (range 1 to 20 months) and median survival was not reached. Six-month survival was 68.5% (95% CI [39.3% to 85.8%]) Conclusions: The combination of Ipilimumab and Nivolumab can result in melanoma control in patients with progression on prior checkpoint monotherapy with an expected toxicity profile.

Stillbirth Rate and Weight at Birth of Quintuplets in Japan

1989 ◽  
Vol 38 (1-2) ◽  
pp. 65-69 ◽  
Author(s):  
Yoko Imaizumi
Keyword(s):  
Sample Size ◽  
Birth Order ◽  
Gestational Age ◽  
Size Effects ◽  
Maternal Age ◽  
Small Sample Size ◽  
Small Sample ◽  
Stillbirth Rate ◽  
The Mean

AbstractNation-wide data in Japan on births and prenatal deaths of 16 sets of quintuplets during 1974-1985 were analysed. Among the 16 sets, 3 sets were liveborn, 8 were stillborn, and 5 were mixed, with a stillbirth rate of 0.64 (51/80). Effects of sex, maternal age and birth order on the stillbirth rate were not considered because of the small sample size. Effects of gestational age and birthweight on stillbirth rate were also examined. The mean weight of the 40 quintuplet individuals was 1,048 g.

Fetal Doppler Parameters at Term in Pregnancies Affected by Gestational Diabetes: Role in the Prediction of Perinatal Outcomes

2018 ◽  
Vol 41 (06) ◽  
pp. 675-680 ◽  
Author(s):  
Alessandra Familiari ◽  
Caterina Neri ◽  
Chiara Vassallo ◽  
Giulia Di Marco ◽  
Serafina Garofalo ◽  
...  
Keyword(s):  
Gestational Diabetes ◽  
Apgar Score ◽  
Adverse Outcome ◽  
Small Sample Size ◽  
Perinatal Outcomes ◽  
Expectant Management ◽  
Well Being ◽  
Good Clinical Practice ◽  
Small Sample ◽  
Fetal Doppler

Abstract Objective The timing of delivery for women affected by gestational diabetes (GDM) is still controversial. Good clinical practice often suggests offering induction of labor at term in order to reduce the complications associated with this condition, while recent evidence supports expectant management. Fetal Doppler parameters represent a validated tool for testing fetal well-being at term and can select pregnancies that need increased surveillance. The aim of the present study was to evaluate the role of fetal Doppler parameters at term for the prediction of pregnancy outcomes in patients affected by GDM. Methods Prospective cohort study in a single center. Evaluation of umbilical artery (UA) PI, middle cerebral artery (MCA) PI, cerebroplacental ratio (CPR) and umbilical-to-cerebral ratio (UCR) at > 37 weeks of gestation in singleton, morphologically normal pregnancies affected by GDM, was performed in order to estimate the association between ultrasound measurements at term and perinatal outcome. Regression linear analysis was used to estimate the association between fetal Doppler parameters and neonatal pH, neonatal Apgar score, neonatal weight and a composite adverse outcome. The receiver operating characteristic (ROC) curve was used to estimate the possible predictive value of the above association. Results Our results on 130 women showed MCA PI to be the best predictor of perinatal outcomes in terms of low Apgar score at the 1st minute (p = 0.00), pH (p = 0.02) and composite adverse outcome (p = 0.05). UCR showed a significant correlation with neonatal pH (p = 0.02). No significant correlations for UA PI and CPR MoMs have been demonstrated in our population. However, the small sample size is a limitation of the study. Conclusion Evaluation of MCA Doppler and eventually UCR at term can be a useful tool to discriminate pregnancies affected by GDM that can benefit from IOL before 41 weeks in order to reduce complications related to this condition.

scholarly journals Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19)

2021 ◽  
Author(s):  
Marvin R. McCreary ◽  
Patrick M. Schnell ◽  
Dale A. Rhoda
Keyword(s):  
Pulmonary Embolism ◽  
Adverse Events ◽  
Small Sample Size ◽  
Primary Outcome Measure ◽  
Small Sample ◽  
Double Blind ◽  
Phase 2 Study ◽  
Clinically Significant ◽  
Low Incidence ◽  
To Receive

Abstract Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol. Both groups received a single dose of Vitamin D3 which was used as an adjunct. The primary outcome measure was hospitalization within 21 days of symptom onset; secondary measures were ER visits, incidence of pneumonia and pulmonary embolism. Five patients chose not to participate after randomization. Twenty-one day outcome was determined of all one hundred participants (mean [SD] age 55.6 [8.8] years; 61% female) (or their surrogates). There were no clinically significant adverse events attributed to resveratrol. Outpatients in this phase 2 study treated with resveratrol had a lower incidence compared to placebo of: hospitalization (2% vs. 6%, RR 0.33, 95% CI 0.04-3.10), COVID-related ER visits (8% vs. 14%, RR 0.57, 95% CI 0.18-1.83), and pneumonia (8% vs. 16%, RR 0.5, 95% CI 0.16-1.55). One patient (2%) in each group developed pulmonary embolism (RR 1.00, 95% CI: 0.06-15.55). This underpowered study was limited by small sample size and low incidence of primary adverse events. A larger trial could determine efficacy.TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04400890 26/05/2020; FDA IND #150033 05/05/2020

The use of frequency distributions in an attempt to detect host mortality induced by infections of diplostomatid metacercariae

Parasitology ◽  
1984 ◽  
Vol 89 (2) ◽  
pp. 209-220 ◽  
Author(s):  
C. R. Kennedy
Keyword(s):  
Small Sample Size ◽  
Parasite Burden ◽  
Fish Host ◽  
Small Sample ◽  
Host Age ◽  
Parasite Abundance ◽  
Frequency Distributions ◽  
Host Mortality ◽  
The Mean ◽  
Over Dispersion

SummaryFollowing recent suggestions that a peaked host age–parasite abundance curve, concomitant with a decline in the degree of dispersion of parasites in the older age classes of hosts, can provide evidence of parasite-induced host mortality, the changes in mean abundance and over-dispersion of metacercarial stages of Diplostomum spathaceum, D. gasterostei, Tylodelphys clavata and T. podicipina in relation to fish age were studied in a field locality. The mean parasite burden of D. spathaceum, D. gasterostei and T. clavata increased with host age and the maximum mean burden was found in the oldest hosts. The variance to mean ratio also increased in D. gasterostei, but decreased in the oldest hosts in D. spathaceum and T. clavata. It is concluded that this decrease could be due to parasite-induced host mortality but could equally be due to death of parasites within the host or to changes in infection rate or could be a reflection of the small sample size of the oldest fish. The mean burden of T. podicipina declined gradually with host age, but the variance to mean ratio remained constant and it is concluded that this could be explained by death of the parasites within the host. None of these data or data from other localities provided clear and unambiguous evidence of host mortality induced by heavy infections of any of the four species, although they are consistent with such mortality and do not refute such a possibility. It is concluded that it may be just as difficult to detect and unequivocally demonstrate parasite-induced host mortality in metacercarial digenean–fish host systems as in any other parasite–host systems.

scholarly journals The Impact of Improved Thermistor Calibration on the Expendable Bathythermograph Profile Data

2017 ◽  
Vol 34 (9) ◽  
pp. 1947-1961 ◽  
Author(s):  
Marlos Goes ◽  
Elizabeth Babcock ◽  
Francis Bringas ◽  
Peter Ortner ◽  
Gustavo Goni
Keyword(s):  
Small Sample Size ◽  
Heat Content ◽  
Small Sample ◽  
Profile Data ◽  
Expendable Bathythermograph ◽  
Different Types ◽  
Long Term Trends ◽  
The Mean ◽  
The Impact

AbstractExpendable bathythermograph (XBT) data provide one of the longest available records of upper-ocean temperature. However, temperature and depth biases in XBT data adversely affect estimates of long-term trends of ocean heat content and, to a lesser extent, estimates of volume and heat transport in the ocean. Several corrections have been proposed to overcome historical biases in XBT data, which rely on constantly monitoring these biases. This paper provides an analysis of data collected during three recent hydrographic cruises that utilized different types of probes, and examines methods to reduce temperature and depth biases by improving the thermistor calibration and reducing the mass variability of the XBT probes.The results obtained show that the use of individual thermistor calibration in XBT probes is the most effective calibration to decrease the thermal bias, improving the mean thermal bias to less than 0.02°C and its tolerance from 0.1° to 0.03°C. The temperature variance of probes with screened thermistors is significantly reduced by approximately 60% in comparison to standard probes. On the other hand, probes with a tighter weight tolerance did not show statistically significant reductions in the spread of depth biases, possibly because of the small sample size or the sensitivity of the depth accuracy to other causes affecting the analysis.

scholarly journals 1013 Dupuytren’s Contracture Treatment with XIAPEX Injection: Reviewing A Single Surgeon's Experience

2021 ◽  
Vol 108 (Supplement_6) ◽  
Author(s):  
M Malik ◽  
B Fourie
Keyword(s):  
Retrospective Review ◽  
Progressive Disease ◽  
Small Sample Size ◽  
Important Change ◽  
Small Sample ◽  
Dupuytren’S Disease ◽  
Dupuytren's Disease ◽  
Post Procedure ◽  
Clinically Significant ◽  
Clinically Important Change

Abstract Aim To review a single surgeon's experience for the treatment of Dupuytren's disease with XIAPEX injection and the clinical outcomes as measured by a URAM score. Method Retrospective review of patient notes, clinical photography and URAM scores for patients who underwent the procedure between August 2013 and October 2016. Results 33 patients underwent the procedure. 25 patients completed pre and post URAM scores. Average pre procedure score was 19.4 and avergae post procedure score was 3.28 a difference of 16.12 (clinically important change for URAM score is 2.9). Average pre procedure MCPJ contracture was 46.67 degrees and average post procedure contracture was 3.3 degrees. Average pre procedure PIPJ contracture was 66.8 degrees and average post procedure contracture was 8.2 degrees. Where both MCPJ and PIPJ affected of the same digit average pre procedure MCPJ and PIPJ contracture was 60 degrees. The post procedure contracture was 0 degrees in the MCPJ and 29.7 degrees in the PIPJ. 1 patient underwent surgery for progressive disease. Conclusions XIAPEX injection has shown a clinically significant result in the treatment of Dupuytren's disease. There were minimal complications and only 1 patient needed further surgery. However, a small sample size thus conclusions have to be cautious.

scholarly journals Geographic Variation of the Curve-Billed Thrasher (Toxostoma Curvirostre) Complex

The Auk ◽  
2003 ◽  
Vol 120 (2) ◽  
pp. 311-322
Author(s):  
Octavio R. Rojas-Soto
Keyword(s):  
Measurement Error ◽  
Small Sample Size ◽  
Morphological Characters ◽  
Color Pattern ◽  
Small Sample ◽  
Sierra Madre Occidental ◽  
Geographic Patterns ◽  
Western Group ◽  
Sierra Madre ◽  
The Mean

Abstract Geographic patterns of variation in morphological characters in the Curve-billed Thrasher (Toxostoma curvirostre) have been recognized by the description of seven subspecies. Twelve standard measurements, as well as three colorimetric characters and two color pattern characters, were analyzed to test whether subspecies limits predict patterns of variation. Measurement error was addressed by measuring each character three times and calculating the mean. A total of 821 male study skins were used, representing 29 locations. A variety of analysis revealed two major groups, an eastern and western group, divided by the Sierra Madre Occidental. Those two groups had previously been recognized as the curvirostre and palmeri groups, respectively. Those groups were also recovered by analysis of mtDNA. The two groups fulfill the requirements for species. The Tiburón Island (T. c. insularis) sample was distinct for several characters; however, small sample size precludes formal taxonomic recommendation. Within the two major groups, most characters showed incongruent clinal patterns of variation that did not match subspecies limits.

Outcome of rapid disease progression in the treatment break following cytoreductive nephrectomy (CN) after presurgical sunitinib in patients with primary metastatic renal cell carcinoma (RCC).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4611-4611
Author(s):  
Axel Bex ◽  
Thomas Powles ◽  
Christian U. Blank ◽  
Simon Chowdhury ◽  
Simon Horenblas ◽  
...  
Keyword(s):  
Disease Progression ◽  
Kinase Inhibitors ◽  
Small Sample Size ◽  
Recovery Period ◽  
Significant Proportion ◽  
Disease Stabilisation ◽  
Small Sample ◽  
Phase Ii Trials ◽  
Exact Test ◽  
Poor Risk

4611 Background: There is concern that interruption of tyrosine kinase inhibitors (TKI) triggers disease progression (PD) and metastasis. This is based on preclinical models and observation of rapid PD in the postsurgical treatment break in patients pretreated with TKI. Little is known about the frequency of PD during postsurgical TKI interruption and its outcome. These data may have implications for neoadjuvant or presurgical treatment concepts. Methods: Of 66 patients from two closed phase II trials investigating 2-3 months presurgical sunitinib for primary metastatic clear-cell RCC, 45 were evaluated in this retrospective analysis because they had absence of PD prior to planned surgery and underwent CN (35 [78%] MSKCC intermediate and 10 [22%] poor risk). Patients had CT scans at the end of pretreatment and at 4 weeks post-nephrectomy before restarting sunitinib. In patients with postsurgical RECIST PD at 4 weeks when compared to the preoperative CT scan overall survival (OS) was measured from the time of nephrectomy and compared to patients without treatment break PD. Results: Median OS of 45 patients from the time of surgery was 22 months (13.0-31.5 months). Overall 14 patients progressed during treatment break (31%), with new sites of disease in 5/14 (35%). Reintroduction of sunitinib resulted in disease stabilisation or better in 13. Patients with poor risk were represented in the progressors (n=4[28%]) and non-progressors (n=6 [19%]) (p=0.7 fishers exact test). The hazard ratio (HR) for death associated with PD during treatment break was 1.90 (95% CI 0.89-4.08). OS for non-progressors was 25 months (15-NA) and 13 months (6-27) for progressors. Conclusions: A significant proportion of patients develop PD upon sunitinib withdrawal in a 4 week recovery period following CN. In view of the small sample size these data suggest a strong trend toward treatment break PD being associated with a poor outcome. It is not clear whether this PD is related to interruption of TKI, surgery or a combination of factors. The EORTC SURTIME trial investigates treatment break PD after immediate CN and CN after sunitinib and may answer this question.

scholarly journals Implementation of a novel prehospital advance directive protocol in southeastern Ontario

CJEM ◽  
2007 ◽  
Vol 9 (04) ◽  
pp. 250-259 ◽  
Author(s):  
Rose P. Mengual ◽  
Michael J. Feldman ◽  
Gord R. Jones
Keyword(s):  
Prospective Observational Study ◽  
Small Sample Size ◽  
Small Sample ◽  
Decision Makers ◽  
Prehospital Setting ◽  
Do Not Resuscitate ◽  
Surrogate Decision Makers ◽  
The Mean ◽  
Surrogate Decision

ABSTRACTIntroduction:Do not resuscitate (DNR) orders are commonly accepted in most health care settings, but are less widely recognized in the prehospital setting. We describe the implementation of and satisfaction with a prehospital DNR protocol that allows paramedics to honour verbal and non-standard written DNR requests.Methods:This prospective observational study reviewed all cardiac arrests in southeastern Ontario between March 1, 2003 and September 31, 2005. Following a verbal or non-standard written DNR request, paramedics completed a questionnaire and a follow-up structured telephone interview was conducted with surrogate decision makers (SDMs).Results:There were 1890 cardiac arrests during the study period, of which 86 met our inclusion criteria. Paramedic surveys were available for 82 cases (95%), and surrogate decision makers (SDMs) were successfully contacted in 50 (58%) of them. Two SDMs declined to be interviewed. The mean patient age was 72.7 (standard deviation 13.8) years and 65% were male. Sixty-three (73%) of DNR requests were verbal, and 23 (27%) were written. The mean paramedic comfort was rated 4.9 on a 5-point Likert scale (with 5 being “very comfortable” ) (95% confidence interval [CI] 4.9–5.0). The mean SDM comfort was rated by paramedics as 4.9 (95% CI 4.8 –4.9). SDMs reported comfort in withholding CPR in 47 of 48 cases (98%), and with paramedic care in all cases. One SDM stated that although it was consistent with the patient's wishes, she was uncomfortable having to make the DNR request.Conclusions:Satisfaction with this novel prehospital DNR protocol was uniformly high among paramedic and SDM respondents. It appears that such a protocol is feasible and acceptable for the prehospital setting. Our conclusions are limited by a small sample size, the lack of a comparison group, and limited follow-up.

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