Educational intervention based on the extended parallel process model improves adherence to diabetic diet and glycaemic control indices: a randomised, double-blind, controlled, factorial field trial.

Nutritional education is pivotal in the medical nutritional therapy of type 2 diabetes mellitus (T2DM). The extended parallel process model (EPPM) is a health education method for inducing desirable health behaviours. The present study aimed to investigate the effect of nutritional education based on the EPPM in T2DM patients on knowledge, attitude, practice, anthropometric indices, glycaemic factors, lipid profile and adherence to the diabetic diet. A randomised, double-blind, controlled, factorial field trial was designed for T2DM patients aged 30-59 years (n 88). Participants were randomly allocated into four groups to receive EPPM-based nutritional education through gain framed message (GFM), loss framed message (LFM), their combination (G\LFM) or usual diabetic education in the control group (CG). Participants were assessed before and after the study duration. After 3 months of intervention, eighty participants finished the study. The EPPM-based intervention increased participants' knowledge, behavioural intention, perceived sensitivity, severity, self-efficacy (P < 0·001 for all) and response efficacy (P = 0·029) in comparison with CG. GFM (P = 0·004) and G\FLM (P = 0·034) reduced carbohydrate intake and LFM (P = 0·034) and G\LFM (P = 0·047) decreased fat intake. Between-group analysis indicated interventions reduced weight (P = 0·046), BMI (P = 0·038), fasting blood sugar (P = 0·030), 2-hour postprandial blood glucose (P = 0·027) and TAG (P = 0·002) in comparison with the CG. Results were NS for protein intake, waist and hip circumference, waist:hip ratio, HbA1c, total cholesterol, LDL and HDL. Nutritional education based on EPPM could increase the knowledge and awareness of T2DM patients. Also, it could be beneficial for blood glucose amendment. Further investigations are recommended.

The effectiveness of educational intervention based on the Health Action Model (HAM) in improving breast cancer screening behaviors.

INTRODUCTION: Breast cancer disease is known as the most common cancer among women. Lack of knowledge and awareness is a leading cause of breast cancer, and since nearly all women are increasingly susceptible to this disease, training screening behaviors for early detection is proven essential in order to reduce breast cancer mortality. Therefore, the present study was designed to determine the effect of educational intervention based on the Health Action Model in improving breast cancer screening behaviors in women aged 30 to 69 in Kashan, Iran. METHODS: This quasi-experimental study was conducted on 162 women aged 30-69 years old among the clients of Comprehensive health service centers in Kashan, Iran and they were assigned to intervention and control groups. The research instrument included a questionnaire assessed within three phases: baseline, 3-months, and 6-months, containing Health Action Model (HAM) structures and also three screening behaviors. The intervention consisted of a model-based education package and was carried out over 2 months. To evaluate the effect of the intervention, the mean of model structures and proportion screening behaviors in the third and sixth months were compared with the baseline phase. All analyses were carried out using SPSS, version 22. RESULTS: The intervention and control groups were homogeneous regarding the structures of the HAM and the proportion of screening behaviors in the baseline phase (p > 0.05). In the 3-month (p < 0.05) and 6-month (p < 0.05) phases, the mean scores of the HAM constructs in the intervention group were found higher compared with the control group. Moreover, the proportion of clinical breast examinations in the intervention group was statistically higher than in the control group in the 3-month (p < 0.001) and 6-month (p < 0.001) phases. In addition, the proportion of mammography performed in the 3-month (p = 0.002) and 6-month (p < 0.001) phases were reported to be higher in the intervention group compared with the control group. CONCLUSION: Overall, these results provide important insight into the effectiveness of the interventions based on the Health Action Model in promoting breast cancer screening behaviors and the determinants of such behaviors.

The effect of educational intervention based on the behavioral reasoning theory on self-management behaviors in type 2 diabetes patients: a randomized controlled trial.

BACKGROUND: Diabetes self-management education is necessary to improve patient outcomes and reduce diabetes-related complications. According to the theory of behavioral reasoning, the likelihood of performing a behavior is predicted by the link between beliefs, motivation, intention, and behavior. This study aimed to investigate the effect of an educational intervention based on the Behavioral Reasoning Theory (BRT) on self-management behaviors in patients with Type 2 Diabetes. METHODS: A randomized controlled trial based on BRT was conducted on 113 patients with type 2 diabetes, with a control group and an intervention group followed for 3and 6 months. Data were collected using a researcher-made demographic questionnaire based on the constructs of BRT and behaviors related to self-management in patients with type 2 diabetes. In the intervention group were provided, 8 sessions of diabetes self-management education based on BRT. The control group only received the usual training of the center. Data was analyzed using SPSS26 software. RESULTS: After the educational interventions in the intervention group, there were statistically significant changes observed in the mean scores of all constructs, fasting blood sugar, and glycosylated hemoglobin. On the other hand, no statistically significant change was observed in the mean grades of the control group. All the observed changes were significant at the 0.05 level. CONCLUSIONS: The results of this study were in favor of the effectiveness of an educational intervention that promotes diabetes self-management behaviors, using the principles of the behavioral reasoning theory. Which can be used in the design of health promotion programs for patients with diabetes. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT), IRCT20131014015015N21.

Evaluating clinical communication skills of medical students, assistants, and professors.

BACKGROUND: The skill of communicating with the patient is one of the basic clinical skills and part of the necessary competencies for medical doctors. The present study aimed to evaluate the knowledge, attitude, and performance (KAP) of medical students, assistants, and professors of Shahrekord University of Medical Sciences regarding clinical communication skills with patients. METHOD: This cross-sectional study was conducted at the hospitals of Shahrekord University of Medical Sciences in Iran. The study included a total of 289 participants, consisting of 51 professors, 72 assistants, 90 external staff, and 76 interns who work at these hospitals. The participants were selected through a convenience sampling method. The data-gathering tools used included a questionnaire to collect demographic characteristics, a researcher-made questionnaire to assess knowledge, a communication skills attitude questionnaire, and a communication skills survey questionnaire. The data were analyzed using descriptive statistics such as mean, standard deviation, and frequency, as well as statistical tests that included one-way ANOVA and Pearson's correlation test. The significance level for the study was considered to be 0.05. RESULTS: The mean scores of knowledge of professors were higher compared to other groups (P = 0.002). All participating groups had a positive attitude toward learning communication skills. There were statistically significant differences between the mean scores of the communication performance of the study groups (P < 0.001). There was a positive relationship between positive attitude and communication performance, and a significant negative relationship was observed between negative attitude and communication performance. CONCLUSION: The results indicate the relatively favorable attitude and performance of the groups and their low knowledge. It is suggested that the doctor-patient communication skills courses be included as one of the necessary courses in the medical education curriculum.

Predictors of hospital nursing staff's adherence to safe injection guidelines: application of the protection motivation theory in Fars province, Iran.

BACKGROUND: Needle stick injuries (NSI) can lead to dangerous infectious diseases for health care workers. This study aimed to determine the predictors of observance of safe injection guidelines in hospital nursing staff, based on protection motivation theory. METHODS: This cross-sectional study was conducted on the nursing staff of five randomly selected teaching and general hospitals of Shiraz University of Medical Sciences, Fars province, Iran, in 2021. Data were collected using a researcher-made questionnaire which was developed based on protection motivation theory. Data were processed and analyzed using SPSS 22 and Amos 24 at a significance level of < 0.05. Pearson's correlation coefficient, Multiple linear regression, and Structural Equation Modeling were used. RESULTS: The mean age of the participants (No = 280) was 32.5 ± 8.09 years. Most of the participants [80%] had encountered NSI, patients' blood, or body fluids at least once. Protection motivation was the only predictor of protective behaviors (ß = 0.573), while perceived efficacy (ß = 0.142) and perceived rewards (ß = -0.229) were the strongest predictors of motivation. The structural equation modeling analysis showed that standardized total effects of protection motivation, perceived response costs, rewards, and efficacy on the protective behaviors were 0.573, -0.159, -.104, and 0.81, respectively. While standardized total effects of perceived rewards, efficacy, and response cost on protection motivation were -0.229, 0.142, and -0.033, respectively. The model fit indices indicated the acceptable final model fit. CONCLUSION: The results suggest that perceived efficacy, perceived effectiveness, and perceived rewards were the most important predictors of adherence to Safe Injection Guidelines in nursing staff.

Psychometric properties of Persian version of the advanced activities of daily living scale: A psychometric study on Iranian older adults.

This study was conducted to determine the psychometric properties of the Persian version of an AADL scale in Iranian older adults. A total of 237 males and females aged over 60 years old were recruited. Personal information questionnaires, the CASP-19 Quality of Life, and AADL questionnaires were used for data collection. SPSS 24 and IBM AMOS 24 were used for data processing and analysis. Three factors that had eigenvalues higher than one were extracted, which explained 51.2 % of the total variances. The Cronbach α of the total score was 0.76, and it was >0.64 for each extracted factor. The goodness of fit indices indicated an acceptable fit to the data in confirmatory factor analysis. The culturally modified Persian version of the AADL scale has acceptable psychometric properties and is proper for evaluating the advanced activities of daily living in the Iranian population.

A health communication campaign for prevention of osteoporosis in rural elderly women.

BACKGROUND: Osteoporosis, as the most common metabolic disease and the leading cause of death among older people, affects more than 200 million women throughout the world. This study aimed to evaluate the effect of a health communication campaign on knowledge, attitude, and practice of older women towards prevention and control of osteoporosis. METHODS: In this multi-stage mixed methods study, 30 days' health communication campaign for prevention of osteoporosis was conducted on 60- 75-year-old women, in rural areas of Fasa, Iran. Subjects were divided into two groups, control (n = 103) and intervention (n = 98). Data were collected using a researcher-made questionnaire and analyzed by SPSS 25.0. The significance level was set at < 0.05. RESULTS: Inter-group group analysis revealed that the mean scores of knowledge, attitude, and practice were not significantly different between the two groups before the intervention, but after the intervention, unlike the behavior (P = 0.569), mean scores of knowledge (p < 0.001) and attitude (p < 0.001) of the intervention group were significantly more than the control group. Intra-group comparisons showed that, unlike the control group, the mean scores of knowledge (p < 0.001), attitudes (p < 0.001), and behavior (P < 0.001) increased significantly in the intervention group. CONCLUSIONS: Health communication campaign is an effective way to change the knowledge and attitude and to a lesser extent the practice of the eldery toward prevention and control of osteoporosis.

The effect of a social cognitive theory-based educational intervention on nonsuicidal self-injury prevention in high school students: A randomized educational intervention trial.

INTRODUCTION: Nonsuicidal self-injury (NSSI) in adolescents is a growing public health concern, demanding preventive measures, particularly among high school students. Based on social cognitive theory (SCT), self-efficacy coupled with outcome expectations, social support, self-regulation, and behavioral intention, determine the likelihood of engaging in such a behavior. Thus, the present study was to investigate the effect of a SCT-based educational intervention on NSSI prevention in female high school students. METHODS: This randomized educational intervention trial was conducted on 191 female high school students, aged 15-17 years (15.95 ± 0.59) (viz. 99 individuals in intervention group and 92 controls). Intervention group attended five SCT-based educational intervention sessions concerning NSSI prevention. Data were then collected by three self-administered questionnaires. The first questionnaire was to measure demographic variables and the second one, intermediate outcome measure, was implemented to evaluate SCT constructs. The third questionnaire also measured NSSI (final outcome measure). Data were analyzed using SPSS software v.24. RESULTS: After controlling the pretest scores, the repeated-measure multivariate analysis of covariance revealed a significant time and group interaction in multivariate (F = 154.8, p < .001) and univariate analysis, which is in favor of the effectiveness of educational intervention on changing the mean scores of NSSI and all SCT constructs. SCT constructs explained 41% of the variance in conforming intention for NSSI prevention (p < .001). CONCLUSION: The study findings were in favor of effectiveness of an SCT-based educational intervention in intention of preventing NSSI.

Predictors of health behavior compliance for the prevention of Covid-19 based on the extended parallel process model in pregnant women in Iran.

Pregnant women are at higher risk of getting severe Covid-19 disease and consequences on the health status of them and their fetuses. Despite vaccination, all preventive behaviors are emphasized. This study aimed to identify the determinants of Covid-19 preventive health behaviors in pregnant women using Extended Parallel Process Model. This cross-sectional study, was conducted on 175pregnant women. The model fit indices were acceptable. Knowledge had indirect effect on adherence to Covid-19 preventive behaviors trough mediating role of self-efficacy and response efficacy. So, it is suggested that, educational interventions should focus on increasing knowledge.

There were statistically significant correlations between all constructs of the EPPM model except knowledge, with adherence to Covid-19 preventive behaviors.Self-efficacy and response efficacy were the strongest predictors of Covid-19 prevention behaviorsPerceived susceptibility and severity were the other significant predictors of Covid-19 preventive behaviors.Knowledge indirectly through the mediating role of response efficiency and self-efficacy effected on preventive behaviors.

Design and psychometric evaluation of the breast cancer screening behaviors scale based on the health action model (HAM).

BACKGROUND: Breast cancer is known as the most common cancer and the first-rank malignancy among women. Screening plays a crucial role in early diagnosis and timely treatment. This paper presents the results of design, evaluation and analysis of a questionnaire based on the health action model to investigate breast cancer screening behaviors and their relevant factors. METHODS: The study is based on using a combination of quantitative and qualitative approaches for optimal design and development of research tools. In order to design the structure of the health action model and screening behaviors related factors, both qualitative methods such as semi-structured interviews and quantitative approaches studied. Psychometric properties of the research tool were investigated through literature review. The research population consisted of 210 30-69 years old females based in Kashan who were selected through simple random sampling. The relative and content validity indexes were calculated to judge the content of the tool. Also, the confirmatory factor analysis was used to evaluate the construct validity. Additionally, intra-class correlation coefficient and Cornbrash's alpha coefficient were calculated to evaluate the reliability of the instrument. The data were analyzed using the SPSS 22 and AMOS 22 software packages. RESULTS: The mean age of the participants was 43 ± 9.82 Years old. The final version of the questionnaire was prepared in four sections, namely demographic factors (15 items), knowledge (12 items), constructs of the health action model or the factors related to breast cancer screening behaviors (67 items), and behavior (6 items). Factor analysis confirmed that the health action model fits in measuring breast cancer screening behaviors. CONCLUSION: The tool designed for measuring breast cancer screening behaviors showed acceptable psychometric properties amongst females and can be used as a valid tool in conducting research in health studies.

Effects of a theory-based training program with follow-up home visits on self-management behavior, glycemic index, and quality of life among Iranian patients with type 2 diabetes mellitus.

BACKGROUND: Uncontrolled diabetes is an important public health problem that endangers the quality of life of patients. Promoting self-management through well-planned training is an essential strategy to control diabetes effectively. This study aimed to examine the effects of a training program based on social cognitive theory (SCT) on self-management behavior, glycemic index, and quality of life among patients with type 2 diabetes mellitus. METHODS: This is a quasi-experimental study with a pretest-posttest design. The statistical population included 106 adults with type 2 diabetes mellitus assigned to the intervention and control groups [n1 = n2 = 53], who received services from two urban health centers. A multi-method, SCT-based training program consisting of six 60-80-min sessions was run, followed by 2-3 follow-up home visits [once a month for each participant] for the intervention group. The data were collected before and three months after the intervention and were analyzed in SPSS 19. RESULTS: Before the intervention, there was no significant difference between the two groups regarding the main variables. After the intervention, there was a significant increase in the intervention group's mean scores of knowledge, self-efficacy, social support, outcome expectations, self-regulation, self-management behavior, glycemic index, and quality of life. There were no significant changes in these constructs in the control group after the intervention. The regression analysis results indicated that social cognitive theory and self-management could explain the variance in quality of life [adjusted R-squared = 0.476]. CONCLUSIONS: The findings support the effectiveness of the multi-method, SCT-based educational intervention in improving self-management behaviors, glycemic index, and quality of life among patients with type 2 diabetes mellitus. It is suggested that the quality of type 2 diabetes care programs should be promoted. However, further research is needed to evaluate the long-term outcomes.

Comparison of the effect of mothers and students' education on the promotion of oral health behaviours in female students, using the health belief model.

BACKGROUND: Oral diseases are considered an important health challenge around the world, especially among children. This study aimed to compare the effects of mothers and students' education on female students' oral health behaviours. METHODS: This three-arm randomized controlled educational trial was conducted on 261 fifth- and sixth-grade female students. The participants were selected and divided into two intervention groups (students' mothers and students) and a control group through simple random sampling. The intervention included four 60-min and two 90-min education sessions for the students and their mothers, respectively. The data were analysed using the SPSS 22 software. RESULTS: The results revealed a significant increase in the mean scores of knowledge (p < 0.001), self-efficacy (p = 0.038), and cues to action (p < 0.001) in the students' intervention group. However, in the students-mothers' group the mean score of knowledge significantly increased (p < 0.001), and perceived barriers significantly decreased (p = 0.001). After the intervention, a significant difference was observed among the three study groups regarding the mean scores of knowledge (p < 0.001), perceived susceptibility (p = 0.005), perceived severity (p = 0.005), perceived benefits (p = 0.011), cues to action (p < 0.001) and brushing and flossing behaviours (p < 0.001). CONCLUSION: In this study, the mothers' education did not have any additional effects on the students' education. It seems that, in underprivileged communities where mothers had a low level of education, it might be better for oral health education to focus more on the students.

Association between methylene tetrahydrofolate reductase polymorphisms and risk of ischemic stroke.

Background: The methylene tetrahydrofolate reductase (MTHFR) is a folate-dependent enzyme which catalyzes the conversion of homocysteine to methionine. Two single nucleotide polymorphisms (SNPs) within this gene namely rs1801133 (C677T) and rs1801131 (A1298C) have been associated with elevated risk of ischemic stroke and total serum homocysteine in some populations.Aim: To assess associations between MTHFR SNPs and risk of ischemic stroke in Iranian population.Methods: In the current case-control study, we genotyped rs1801133 and rs1801131 SNPs in 318 Iranian patients with history of ischemic stroke and 400 age- and sex-matched controls using tetra-primer amplification refractory mutation system-polymerase chain reaction method.Results: The rs1801133 was significantly associated with risk of stroke in recessive model (OR (95% CI) = 1.89 (1.12-3.20), p = 0.03). The CT haplotype (rs1801131 and rs1801133, respectively) was significantly over-represented in patients compared with controls (OR (95% CI) = 1.71 (0.25-2.32), p = 0.002).Conclusion: Consequently, our data demonstrate contribution of MTHFR variants in risk of ischemic stroke in Iranian population.

Dose spouses' coping skills promote qol and dyadic coping of menopausal women?

Lack of menopausal knowledge damages the quality of life (QoL) and couples' relationships. A new approach to prevent marital distress based upon stress and coping has introduced Couples Coping Enhancement Training (CCET). The present study assessed the effect of menopause care training using CCET approach on QoL and coping in menopausal women. This educational interventional study was conducted in 2019 on 80 postmenopausal women and their spouses. The couples were randomly selected from health care centers using the cluster random sampling method and were divided into control and intervention groups. Four training sessions were held for the intervention group. Data were collected using The Menopause-Specific Quality of Life (MENQOL) questionnaire, menopausal knowledge questionnaire, and Dyadic Coping Inventory (DCI) and were analyzed using independent Sample t-test, Paired Sample T-Test, and Structural Equation Modeling (SEM) in SPSS version 25 and Amos version 21 software. At the beginning of the study, there was no significant difference in menopausal knowledge, QoL, and dyadic coping between the two groups. However, the CCET approach significantly increased menopausal knowledge, coping in couples and women's QoL in the intervention group compared to the control group. CCET can help couples to cope with menopausal symptoms more efficiently.

Developing strategies to improve the community readiness level to prevent drug abuse in adolescents: Based on the community readiness model, Eghlid City, Iran, 2019.

The aim of this study was to investigate the level of readiness of Eghlid city community for adolescents' substance abuse prevention programs, and to develop strategies to improve community readiness levels based on the community readiness model (CRM). In this two-stage qualitative study, a 36-item semi-structured CRM questionnaire, was used to interview 11 key informants in Eghlid city, Iran, 2019. The interviews were analyzed and scored by two independent researchers. Strategies for increasing the level of readiness were developed and prioritized by participants using the nominal group method. The readiness levels to prevent substance abuse in community efforts and leadership dimensions were at stabilization and preparation stage. In terms of community awareness of efforts, community space, and public awareness of the issue, the readiness level was at the pre-planning stage, and in the resources for prevention efforts dimension, it was at the vague awareness level. In the strategy development section, the key participants focused on using traditional methods such as holding face-to-face training programs and festivals, using IRIB platform, local media, and lectures. The general level of readiness is at a moderate level. It seems necessary to focus on resources and areas related to public information.

Genetic anticipation in Swedish Lynch syndrome families.

Among hereditary colorectal cancer predisposing syndromes, Lynch syndrome (LS) caused by mutations in DNA mismatch repair genes MLH1, MSH2, MSH6 or PMS2 is the most common. Patients with LS have an increased risk of early onset colon and endometrial cancer, but also other tumors that generally have an earlier onset compared to the general population. However, age at first primary cancer varies within families and genetic anticipation, i.e. decreasing age at onset in successive generations, has been suggested in LS. Anticipation is a well-known phenomenon in e.g neurodegenerative diseases and several reports have studied anticipation in heritable cancer. The purpose of this study is to determine whether anticipation can be shown in a nationwide cohort of Swedish LS families referred to the regional departments of clinical genetics in Lund, Stockholm, Linköping, Uppsala and Umeå between the years 1990-2013. We analyzed a homogenous group of mutation carriers, utilizing information from both affected and non-affected family members. In total, 239 families with a mismatch repair gene mutation (96 MLH1 families, 90 MSH2 families including one family with an EPCAM-MSH2 deletion, 39 MSH6 families, 12 PMS2 families, and 2 MLH1+PMS2 families) comprising 1028 at-risk carriers were identified among the Swedish LS families, of which 1003 mutation carriers had available follow-up information and could be included in the study. Using a normal random effects model (NREM) we estimate a 2.1 year decrease in age of diagnosis per generation. An alternative analysis using a mixed-effects Cox proportional hazards model (COX-R) estimates a hazard ratio of exp(0.171), or about 1.19, for age of diagnosis between consecutive generations. LS-associated gene-specific anticipation effects are evident for MSH2 (2.6 years/generation for NREM and hazard ratio of 1.33 for COX-R) and PMS2 (7.3 years/generation and hazard ratio of 1.86). The estimated anticipation effects for MLH1 and MSH6 are smaller.

A retrospective study of extracolonic, non-endometrial cancer in Swedish Lynch syndrome families.

BACKGROUND: Lynch Syndrome is an autosomal dominant cancer syndrome caused by pathogenic germ-line variants in one of the DNA-mismatch-repair (MMR) genes MLH1, MSH2, MSH6 or PMS2. Carriers are predisposed to colorectal and endometrial cancer, but also other cancer types. The purpose of this retrospective study was to characterize the tumour spectrum of the Swedish Lynch syndrome families. METHODS: Data were obtained from genetically verified 235 Lynch families from five of the six health care regions in Sweden. The material was stratified for gender, primary cancer, age and mutated gene and the relative proportions of specific cancer types were compared to those in the general population. RESULTS: A total of 1053 family members had 1493 cancer diagnoses of which 1011 were colorectal or endometrial cancer. Individuals with pathogenic variants in MLH1 and MSH2 comprised 78% of the cohort. Among the 482 non-colorectal/non-endometrial cancer diagnoses, MSH2 carriers demonstrated a significantly increased proportion of urinary tract, gastric, small bowel, ovarian and non-melanoma skin cancer compared to the normal population. MLH1 carriers had an elevated proportion of gastrointestinal cancers (gastric, small bowel, pancreas), while MSH6 carriers had more ovarian cancer than expected. Gastric cancer was predominantly noted in older generations. CONCLUSION: Lynch syndrome confers an increased risk for multiple cancers other than colorectal and endometrial cancer. The proportions of other cancers vary between different MMR genes, with highest frequency in MSH2-carriers. Gender and age also affect the tumour spectrum, demonstrating the importance of additional environmental and constitutional parameters in determining the predisposition for different cancer types.

A phase I dose escalation trial of AXP107-11, a novel multi-component crystalline form of genistein, in combination with gemcitabine in chemotherapy-naive patients with unresectable pancreatic cancer.

BACKGROUND: AXP107-11 is a novel, multi-component crystalline form of the naturally occurring compound genistein. AXP107-11 has improved physiochemical properties and oral bioavailability compared to the natural form of genistein, and it is possible that combining AXP107-11 with chemotherapy may increase the effect and reduce chemoresistance. The purpose of this dose escalation phase Ib study was to assess the safety, maximum tolerated dose (MTD) and pharmacokinetics (PK) of AXP107-11 in combination with gemcitabine in treatment-naïve patients with inoperable pancreatic carcinoma. PATIENTS AND METHODS: AXP107-11 was given orally in escalating doses (400 mg-1600 mg daily) in combination with standard gemcitabine treatment (1000 mg/m(2)/week) for the first seven of eight weeks and thereafter for a maximum of four × four-week treatment cycles. PK, safety, MTD and efficacy of AXP107-11 in combination with gemcitabine were evaluated. RESULTS: Sixteen patients were enrolled and received AXP107-11. The maximum concentration in serum of unconjugated (free) genistein was 1 µM. Neither dose-limiting toxicities (DLTs) nor signs of hematological or non-hematological toxicities related to AXP107-11 were observed over a period ranging from 0.7 to 13.2 months. The median overall survival time was 4.9 months (range 1.5-19.5 months). Seven patients (44%) survived longer than six months and 19% were alive at the one-year follow-up. CONCLUSION: Treatment of pancreatic cancer patients with AXP107-11 in combination with gemcitabine resulted in a favorable PK-profile with high serum levels without signs of either hematological or non-hematological toxicity. Accordingly, we suggest further studies with AXP107-11 in pancreatic cancer patients.

The effects of green tea tablets and metformin on ovulation and menstrual cycle regularity in women with polycystic ovary syndrome.

Polycystic ovary syndrome is the most common cause of oligo-ovulation and anovulation among women of reproductive age, contributing to infertility. This study aimed to compare the effects of green tea tablets and metformin on ovulation, menstrual cycle regularity, and antioxidant biomarkers in women with polycystic ovary syndrome (PCOS). In this clinical trial study, 94 women with PCOS were randomly assigned to three groups: green tea (n = 33), metformin (n = 29), and control (n = 32). Menstrual status and oxidative stress parameters, including total antioxidant capacity, thiol, and lipid peroxidation, were compared before and 3 months after the intervention among all three groups. Data analysis was conducted using SPSS software version 22 and employing the analysis of variance and paired t-tests. Following the intervention, the mean menstrual cycle duration in the green tea, metformin, and control groups was 32.22 ± 12.78, 48.72 ± 37.06, and 48.53 ± 31.04 days, respectively (P = 0.040). There was no statistically significant difference between the three groups in terms of biochemical, hormonal, and antioxidant indices before and after the intervention (P > 0.05). The intake of green tea tablets was associated with better outcomes in regulating the menstrual cycle in women with PCOS.