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Background: The Covid-19 pandemic, the subsequent lockdown, and the measures of social distancing may have had adverse effects on patients with epilepsy (PWE). This study was designed to assess the pandemic's psychological impact on the Greek non-infected PWE and possible changes in their seizure control., Method: The patients were evaluated utilizing a semi-structured interview consisting of open questions regarding their demographic, social, and clinical characteristics, followed by five questions (on a scale of 0-10) related to the Covid-19 pandemic, lockdown, and social distancing measures. Anxiety and depression of PWE were screened using the Hospital Anxiety and Depression Scale (HADS), which consists of HADS-Anxiety and HADS-Depression subscales., Results: We evaluated 65 PWE in the outpatient clinic (60 %) or via telephone interview (40 %). None of these patients experienced changes in seizure control. The mean scores of the Covid-19-related questions were 6.1 ± 2.7 (fear of getting infected), 4.7 ± 3.3 (fear of death), 7.1 ± 2.7 (fear of sickness for their relatives), 6.4 ± 3.1 (stress during lockdown), and 3.0 ± 2.9 (fear of antiepileptic drugs unavailability). Thirty-nine (60 %) patients screened positive for anxiety and thirty-three (50.8 %) for depression., Conclusion: The psychological impact of the Covid-19 pandemic, lockdown, and social distancing measures on non-infected PWE was moderate without changes in their seizure control. HIPPOKRATIA 2021, 25 (4):145-150., (Copyright 2021, Hippokratio General Hospital of Thessaloniki.)

Therapeutic interventions with aldose reductase inhibitors appear to be a promising approach to major pathological conditions (i.e. neuropathy/angiopathy related to chronic hyperglycemia, chronic inflammation and cancer). Until now, the most potent aldose reductase inhibitors have been carboxylic acid derivatives, which poorly permeate biological membranes. In this work, continuing our previous works, we promote the bioisosteric replacement of the carboxylic acid moiety to make equally potent yet more druggable inhibitors., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Metastatic anal cancer is a rare disease in the Western hemisphere and current treatment modalities are not effective. In this study, patients with advanced epithelial cancer of the anal canal received MAP followed by Bleomycin and CCNU upon progression of disease. Twelve out of twenty eligible patients had a partial response 60%, (95% CI {36% -81%}). No complete responses were observed. The median survival was 15 months (95% CI {6-20} months). The median time to progression or death was 8 months (95% CI {4-9 months}). Toxicities were moderate and tolerable with routine supportive care; there were 2 cases of grade 3 vomiting, 2 cases of respiratory distress (one grade 1 and one grade 3), one case each of grade 3 leg cramps and cardiac arrhythmia. Of particular note were 7 cases of grade 3 hematologic toxicity. Two patients had grade 4 leukopenia and thrombocytopenia, respectively, that resolved without sequelae. The combination therapy of MAP followed by Bleomycin and CCNU for patients with advanced anal cancer, not amenable to radiotherapy or surgery, results in a moderate objective response but with moderate toxicities. This regimen and sequence is worthy of further study especially in combination with colony stimulating factors, however, its tolerability may be most applicable for patients who have had minimal prior therapy.

Purpose: To compare the efficacy and the toxicity of cisplatin and 5-fluorouracil (PF) and mitomycin C, vincristine, cisplatin and 5-fluorouracil (MVPF) in patients with metastatic large bowel cancer., Patients and Methods: A total of 94 patients with no prior chemotherapy and measurable metastatic large bowel cancer were randomly assigned to one of the two treatment regimens. Eastern Cooperative Oncology Group (ECOG) criteria were used to evaluate response and toxicity., Results: Fifty patients were randomized to PF and 44 to MVPF. Toxicity was evaluable in all patients except one; response was evaluable in 40 and 31, with response rate of 13 and 42%, respectively. Intent-to-treat analysis showed a response rate of 12 and 32%, respectively (p = 0.076), where it was assumed that none of the ineligible or unevaluable patients responded. Median survival for all patients was 9 months, with no difference between PF and MVPF. ECOG Performance Status (0 vs. 1), weight loss (< or =10 vs. >10%) and site of metastatic lesion had statistically significant impact on survival. MVPF was definitely more toxic than PF (p < 0.000005)., Conclusion: Both treatment regimens showed clinical activity. The MVPF regimen resulted in more responses than PF, no improvement in survival, and more toxicity., (Copyright 2004 S. Karger AG, Basel)

This paper investigates one- and two-sample problems comparing survival times when an individual may experience an intermediate event prior to death or reaching some well defined endpoint. The intermediate event may be polychotomous. Patients experiencing the intermediate event may have an altered survival distribution after the intermediate event. Score tests are derived for testing if the occurrence of the intermediate event actually alters survival. These models have implications for evaluating therapies without randomization as well as strengthening the log rank test for comparing two survival distributions. The exact distribution of the score tests can be found by conditioning on both the waiting time and occurrence of the intermediate event.

The applied statistician often encounters the need to compare two or more groups with respect to more than one outcome or response. Several options are generally available, including reducing the dimension of the problem by averaging or summarizing the outcomes, using Bonferroni or other adjustments for multiple comparisons, or applying a global test based on a suitable multivariate model. For normally distributed data, it is well established that global tests tend to be significantly more sensitive than other procedures. While global tests have also been proposed for multiple binary outcomes, their properties have not been well studied nor have they been widely discussed in the context of clustered data. In this paper, we derive a class of quasi-likelihood score tests for multiple binary outcomes, and show that special cases of this class correspond to other tests that have been proposed. We discuss extensions to allow for clustered data, and compare the results to the simple approach of collapsing the data to a single binary outcome, indicating the presence or absence of at least one response. The asymptotic relative efficiencies of the tests are shown to depend not only on the correlation between the outcomes, but also on the response probabilities. Although global tests based on a multivariate model are generally recommended, our findings suggest that a test based on the collapsed data can maintain surprisingly high efficiency, especially when the outcomes of interest are rare. Data from several developmental toxicity studies illustrate our results.

In an analysis of recent behavior with regard to quitting smoking, detailed histories were obtained on a representative sample of 5,623 Americans who had smoked in the year preceding the 1986 Adult Use of Tobacco Survey. An estimated 55.8 million Americans smoked regularly for some period during the year prior to the survey. Approximately one third (34.8%) quit for at least a day during the year prior to the survey, 28.3% quit for at least 7 days during the year prior to the survey, and 16.2% were still not smoking at the time of the survey. Of those who quit for a day, 54% had relapsed by the time of the survey. Demographic characteristics, such as age, sex, race, marital status, and education, were evaluated as predictors of making a major attempt to quit for 7 days or more. Among those who had made a major attempt, a similar analysis was done predicting success in maintaining cessation for 3 months or more. Ordinal logistic regression analyses showed that younger age and higher education predicted a major attempt to quit. There was only one group who differed markedly from all others: those who were younger and were more highly educated. Older age and being white predicted those who abstained for 3 months or longer.

Although the fundamental principles that drive the design, conduct, and analysis of clinical trials are as applicable to AIDS as to other diseases, there is no question that we have been confronted with unusually difficult challenges in studying therapeutic approaches in this disease area. Treatments are being developed that show great promise, but when investigated further some may be seen to offer no clinical benefit and others may do active harm through toxicity. A group of biostatisticians, meeting in association with the AIDS Clinical Trials Group (ACTG), has discussed and written a report on a number of issues, primarily related to principles of study design, with the goal of stimulating thought on new study designs and the timely implementation of well-designed trials to identify effective treatment strategies for HIV-infected populations. These issues include (1) progression of clinical trials through phases, (2) choices of outcomes, (3) breadth and complexity of clinical trials (eligibility criteria and "low-tech" trials, (4) alternative designs to be used in randomized trials, and (5) the concept of randomized clinical trials as a desirable option, both for patients and for science. The current HIV epidemic makes the requirements of obtaining valid scientific comparisons more important, not less so, but the challenge is to expedite this process.

The Eastern Cooperative Oncology Group (ECOG) entered 326 patients with advanced measurable colorectal cancer into four phase II drug or drug combination trials. Previously treated and chemotherapy-naive patients were eligible. Chlorozotocin was administered to 83 patients (51 previously treated), methyl-glyoxal-bis-guanylhydrozone (MGBG) to 90 patients (58 previously treated), and two regimens of the three-drug combination of cyclophosphamide, vincristine, and methotrexate (COM) to 153 patients (120 previously treated). The multidrug regimen had been developed specifically for previously treated patients. In this trial, chemotherapy-naive patients were no more likely to respond than were members of the previously-treated group. Even among previously untreated patients, response rates did not exceed 10% in any of these phase II programs. They are not recommended for further trials in patients with colorectal cancers.