Cabozantinib plus Nivolumab and Ipilimumab in Renal-Cell Carcinoma.

BACKGROUND: The efficacy and safety of treatment with cabozantinib in combination with nivolumab and ipilimumab in patients with previously untreated advanced renal-cell carcinoma are unknown. METHODS: In this phase 3, double-blind trial, we enrolled patients with advanced clear-cell renal-cell carcinoma who had not previously received treatment and had intermediate or poor prognostic risk according to the International Metastatic Renal-Cell Carcinoma Database Consortium categories. Patients were randomly assigned to receive 40 mg of cabozantinib daily in addition to nivolumab and ipilimumab (experimental group) or matched placebo in addition to nivolumab and ipilimumab (control group). Nivolumab (3 mg per kilogram of body weight) and ipilimumab (1 mg per kilogram) were administered once every 3 weeks for four cycles. Patients then received nivolumab maintenance therapy (480 mg once every 4 weeks) for up to 2 years. The primary end point was progression-free survival, as determined by blinded independent review according to Response Evaluation Criteria in Solid Tumors, version 1.1, and was assessed in the first 550 patients who had undergone randomization. The secondary end point was overall survival, assessed in all patients who had undergone randomization. RESULTS: Overall, 855 patients underwent randomization: 428 were assigned to the experimental group and 427 to the control group. Among the first 550 patients who had undergone randomization (276 in the experimental group and 274 in the control group), the probability of progression-free survival at 12 months was 0.57 in the experimental group and 0.49 in the control group (hazard ratio for disease progression or death, 0.73; 95% confidence interval, 0.57 to 0.94; P = 0.01); 43% of the patients in the experimental group and 36% in the control group had a response. Grade 3 or 4 adverse events occurred in 79% of the patients in the experimental group and in 56% in the control group. Follow-up for overall survival is ongoing. CONCLUSIONS: Among patients with previously untreated, advanced renal-cell carcinoma who had intermediate or poor prognostic risk, treatment with cabozantinib plus nivolumab and ipilimumab resulted in significantly longer progression-free survival than treatment with nivolumab and ipilimumab alone. Grade 3 or 4 adverse events were more common in the experimental group than in the control group. (Funded by Exelixis; COSMIC-313 ClinicalTrials.gov number, NCT03937219.).

Mechanisms of mindfulness for professional golfers: the mediating role of basic psychological needs.

The relationship between mindfulness and well-being and ill-being has been demonstrated to a great extent. In sports, the fulfillment of individuals' basic psychological needs depends mostly on support from others, such as that from a coach in a sports team context. However, a possible way for individuals to fulfill their basic psychological needs is by enhancing mindfulness rather than depending on others. Therefore, building on SDT and mindfulness, this study examines the mediating effect of basic psychological needs on mindfulness to predict subjective vitality and athlete burnout in professional golfers. The participants were 120 golfers (47% females), with a mean age and golf experience of 22.28 and 9.48 years, respectively. The association between mindfulness and subjective vitality was partially mediated by the need for autonomy and relatedness. By contrast, the association between mindfulness and burnout was partially mediated by the need for competence and relatedness, thus supporting our mediation analysis. Overall, the study highlights mindfulness as a potential mechanism to ensure the fulfillment of basic psychological needs in golf training, which could enhance golfers' subjective vitality and reduce the occurrence of burnout.

A phase III, randomized, open-label study (CONTACT-02) of cabozantinib plus atezolizumab versus second novel hormone therapy in patients with metastatic castration-resistant prostate cancer.

Cabozantinib inhibits multiple receptor tyrosine kinases, including the TAM kinase family, and may enhance response to immune checkpoint inhibitors. One cohort of the ongoing phase Ib COSMIC-021 study (NCT03170960) evaluating cabozantinib plus the PD-L1 inhibitor atezolizumab in men with metastatic castration-resistant prostate cancer (mCRPC) that has progressed in soft tissue on/after enzalutamide and/or abiraterone treatment for metastatic disease has shown promising efficacy. Here, we describe the rationale and design of a phase III trial of cabozantinib plus atezolizumab versus a second novel hormone therapy (NHT) in patients who have previously received an NHT for mCRPC, metastatic castration-sensitive PC or nonmetastatic CRPC and have measurable visceral disease and/or extrapelvic adenopathy - a population with a significant unmet need for treatment options. Trial Registration Clinical Trial Registration: NCT04446117 (ClinicalTrials.gov) Registered on 24 June 2020.

Operationally defining physical literacy in Chinese culture: Results of a meta-narrative synthesis and the Panel's recommendations.

Purpose: The definition of physical literacy (PL) needs to be explored by researchers from educational, public health, and sports organisations in Chinese culture; an adequate definition and theoretical framework of PL can then be embraced within different contexts and according to cultural influences. Methods: This meta-narrative synthesis of literature in this area included a series of planning, search, mapping, appraisal, synthesis, and recommendation phases. The literature was translated into English and circulated among international experts to seek suggestions. A total of 74 articles were included in the PL definition synthesis and 28 were included for philosophical synthesis in this study. Results: Based on three rounds of discussions, the final agreement was reached among panel members regarding the defining statements and practical and theoretical models of PL in Chinese culture. According to consensus, PL is the integration of physical, perceptual, cognitive, psychological, and behavioural capabilities, echoing with the need for an active, healthy, and fulfilling lifestyle, which involves continuous positive interactions with the environment and embodied engagement in physical activities for life. The framework addressed five domains (physical, sensory-perceptual, cognitive, psychological, and behavioural) and one important overlapping factor (dynamic environment). A further explanation was provided in the defining statement to assist in understanding the concept. Conclusion: It is suggested that the cultural interpretation and historical background of PL in Chinese discourse should be addressed and respected. The development of a specific cultural definition statement of PL in one country could provide implications for PL researchers worldwide.

Efficacy and Safety of Enzalutamide vs Bicalutamide in Younger and Older Patients with Metastatic Castration Resistant Prostate Cancer in the TERRAIN Trial.

PURPOSE: Enzalutamide significantly prolonged median progression-free survival vs bicalutamide in chemotherapy naïve men with metastatic castration resistant prostate cancer in the TERRAIN (Enzalutamide versus Bicalutamide in Castrate Men with Metastatic Prostate Cancer) trial. In this post hoc analysis we investigated the influence of age on the efficacy and safety of enzalutamide vs bicalutamide in this population. MATERIALS AND METHODS: Patients were randomized 1:1 to enzalutamide 160 mg per day or bicalutamide 50 mg per day. Progression-free survival, time to prostate specific antigen progression and safety were analyzed post hoc in younger (age less than 75 years) and older (age 75 years or greater) subgroups. RESULTS: Enzalutamide significantly reduced the risk of disease progression or death vs bicalutamide in patients younger than 75 years (HR 0.38, 95% CI 0.27-0.52, p <0.0001) and 75 years old or older (HR 0.59, 95% CI 0.37-0.92, p = 0.018). Time to prostate specific antigen progression was also significantly prolonged with enzalutamide vs bicalutamide in each subgroup. The adverse event distribution between treatments was similar in each subgroup except for more (5% or greater difference between subgroups) atrial fibrillation, urinary tract infections, falls and decreased appetite as well as less extremity pain and hot flushing in enzalutamide treated patients 75 years old or older, and less back pain and hot flushing in bicalutamide treated patients 75 years old or older. Grade 3 or greater cardiac events were more frequent in enzalutamide treated and bicalutamide treated patients who were 75 years old or older vs younger than 75 years. Fatigue was more frequent in enzalutamide treated patients with a similar distribution in each age subgroup. CONCLUSIONS: Enzalutamide improved clinical outcomes vs bicalutamide irrespective of age. Increased falls and cardiac events suggest caution when prescribing to older patients (age 75 years or greater) with significant comorbidity.

Perceived physical literacy instrument for adolescents: A further validation of PPLI.

BACKGROUND/OBJECTIVE: The purpose of this study is to examine the reliability and validity of "Perceived Physical Literacy Instrument" (PPLI) questionnaire in adolescents. METHODS: Based on physical literacy literature, a 9-item instrument was developed for initial tests. The self-report measure was administered to 1945 adolescents in Hong Kong. Confirmatory factor analysis (CFA) was used to examine a three-factor structure of physical literacy. A chi-square difference test analysed several competing models and compared the results between the proposed models (i.e., a three-factor solution) and other alternative models (i.e., a one-factor or two-factor solution). Furthermore, the measurement invariance across gender groups was examined by using multiple-group confirmatory factor analysis. Mean scores for physical literacy factors were also examined by demographic characteristics. RESULTS: Confirmatory factor analysis (CFA) showed that the construct demonstrated a good fit to the model. For convergent validity, our results, evaluating the factor loading of each items, the values of composite reliability (CR) and the average variance extracted (AVE) of the three factors, revealed that the three-factor validity of physical literacy was satisfactory. The chi-square difference test between models was significant indicating that all the latent variables had satisfactory discriminant validity. Moreover, the findings of measurement invariance showed that the PPLI is invariant across gender. CONCLUSIONS: The PPLI thus appeared to be reliable and valid as a measure of the perceived physical literacy of adolescents. Thus, along with other validated instruments, protocols and research designs, the PPLI could be widely used to test adolescents' self-perception of physical literacy and their own physical and mental health conditions and thereby health. Physical education professionals may thus recommend appropriate intervention programmes for younger generations.

Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomised, double-blind, phase 2 study.

BACKGROUND: Enzalutamide is an oral androgen-receptor inhibitor that has been shown to improve survival in two placebo-controlled phase 3 trials, and is approved for patients with metastatic castration-resistant prostate cancer. The objective of the TERRAIN study was to compare the efficacy and safety of enzalutamide with bicalutamide in patients with metastatic castration-resistant prostate cancer. METHODS: TERRAIN was a double-blind, randomised phase 2 study, that recruited asymptomatic or minimally symptomatic men with prostate cancer progression on androgen-deprivation therapy (ADT) from academic, community, and private health-care provision sites across North America and Europe. Eligible patients were randomly assigned (1:1) via an interactive voice response system to receive enzalutamide 160 mg/day or bicalutamide 50 mg/day, both taken orally, in addition to ADT, until disease progression. Patients were stratified by a permutated block method (block size of four), by whether bilateral orchiectomy or receipt of luteinising hormone-releasing hormone agonist or antagonist therapy started before or after the diagnosis of metastases, and by study site. Participants, investigators, and those assessing outcomes were masked to group assignment. The primary endpoint was progression-free survival, analysed in all randomised patients. Safety outcomes were analysed in all patients who received at least one dose of study drug. The open-label period of the trial is in progress, wherein patients still on treatment at the end of the double-blind treatment period were offered open-label enzalutamide at the discretion of the patient and study investigator. This trial is registered with ClinicalTrials.gov, number NCT01288911. FINDINGS: Between March 22, 2011, and July 11, 2013, 375 patients were randomly assigned, 184 to enzalutamide and 191 to bicalutamide. 126 (68%) and 168 (88%) patients, respectively, discontinued their assigned treatment before study end, mainly due to progressive disease. Median follow-up time was 20·0 months (IQR 15·0-25·6) in the enzalutamide group and 16·7 months (10·2-21·9) in the bicalutamide group. Patients in the enzalutamide group had significantly improved median progression-free survival (15·7 months [95% CI 11·5-19·4]) compared with patients in the bicalutamide group (5·8 months [4·8-8·1]; hazard ratio 0·44 [95% CI 0·34-0·57]; p<0·0001). Of the most common adverse events, those occurring more frequently with enzalutamide than with bicalutamide were fatigue (51 [28%] of 183 patients in the enzalutamide group vs 38 [20%] of 189 in the bicalutamide group), back pain (35 [19%] vs 34 [18%]), and hot flush (27 [15%] vs 21 [11%]); those occurring more frequently with bicalutamide were nausea (26 [14%] vs 33 [17%]), constipation (23 [13%] vs 25 [13%]), and arthralgia (18 [10%] vs 30 [16%]). The most common grade 3 or worse adverse events in the enzalutamide or bicalutamide treatment groups, respectively, were hypertension (13 [7%] vs eight [4%]), hydronephrosis (three [2%] vs seven [4%]), back pain (five [3%] vs three [2%]), pathological fracture (five [3%] vs two [1%]), dyspnoea (four [2%] vs one [1%]), bone pain (one [1%] vs four [2%]), congestive cardiac failure (four [2%] vs two [1%]), myocardial infarction (five [3%] vs none), and anaemia (four [2%] vs none]). Serious adverse events were reported by 57 (31%) of 183 patients and 44 (23%) of 189 patients in the enzalutamide and bicalutamide groups, respectively. One of the nine deaths in the enzalutamide group was thought to be possibly related to treatment (due to systemic inflammatory response syndrome) compared with none of the three deaths in the bicalutamide group. INTERPRETATION: The data from the TERRAIN trial support the use of enzalutamide rather than bicalutamide in patients with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer. FUNDING: Astellas Pharma, Inc and Medivation, Inc.

How Leisure Involvement Affects Repurchase Intention in Fitness Clubs? The Mediating Role of Commercial Friendship.

This study explores the relationships among leisure involvement, business or commercial friendship, satisfaction, and willingness to repurchase in customers' use of customized fitness services. This study randomly sampled and analyzed the customers of fitness clubs (N = 234) in China. The results showed that leisure involvement had a positive impact on repurchase intention and satisfaction. Moreover, the mediating effect of commercial friendship was found in the relationship between leisure involvement, repurchase intention, and satisfaction. Overall, the study contributes to the literature by exploring the interaction effects of different types of consumer leisure involvement and commercial friendships in customized fitness services models on satisfaction and repurchase intentions'.

Marketing strategies of the female-only gym industry: A case-based industry perspective.

Female customers are an important market for fitness centers. This study aims to examine successful fitness training health models used by female fitness clubs. A case study approach and the interview method were used to collect data (i.e., face-to-face interviews) regarding the marketing strategies of female fitness clubs. Purposive sampling was employed to select executives working at the headquarters of a female-only gym, and semi-structured interviews were conducted to provide a context for fitness behaviors and to discuss the business' marketing mix. Six managers at Curves (four female and two male) across six different positions were interviewed. This study found that Curves' most significant difference compared to other private fitness clubs is that it makes women feel comfortable. Through charitable activities combined with promotions, women feel as if the gym empathizes with them. This study is unique in that it is one of the first studies to explore the business model of the female fitness club. In particular, this research suggests that sports organizations should focus their services strategies on female exercise demands. The findings of this study will support the development of marketing strategies to promote the growth of women's health as a priority within the fitness industry.

A preliminary study on the effectiveness of a stress management program for healthcare-related undergraduates with at-risk mental state.

PURPOSE: This study aimed to examine the effects of a stress management program on stress perception and coping strategies for healthcare-related undergraduates with at-risk mental state (ARMS). DESIGN AND METHODS: A randomized experimental design with pretest and posttest was used. Of the 2812 students screened, 65 were identified as having ARMS, 52 enrolled in the study, and 49 (75%) completed the study. FINDINGS: Significance was found for subjects with schizotypal traits in emotion expression and problem-avoidance coping strategies. Subjects with trait anxiety improved significantly in interpersonal deficits after the program. PRACTICE IMPLICATIONS: Students with different trait risks reported benefits in different stress-coping strategies from the program.

Temporal Precedence of Physical Literacy and Basic Psychological Needs Satisfaction: A Cross-Lagged Longitudinal Analysis of University Students.

: Purpose: Building on self-determination theory and extending research in the physical education context in terms of basic psychological needs satisfaction and physical literacy, this study examines the bidirectional effects of basic psychological needs satisfaction and physical literacy over time in a university physical literacy context. METHOD: Using a two-wave design, data were collected twice with an 18-week time lag from a sample of 549 university students. Utilizing full cross-lagged analyses, we examined the bidirectional effects between basic psychological needs satisfaction and physical literacy. RESULTS: The results provide support for a positive relationship between physical literacy (Time 1) and basic psychological needs satisfaction (Time 2), but we cannot reject the possibility of a bidirectional relation, supporting our expectations. CONCLUSION: Overall, the study highlights the importance of a reciprocal relationship between physical literacy and basic psychological needs satisfaction.

Seizure Rates in Enzalutamide-Treated Men With Metastatic Castration-Resistant Prostate Cancer and Risk of Seizure: The UPWARD Study.

Importance: The androgen receptor inhibitor enzalutamide prolongs survival in men with metastatic castration-resistant prostate cancer (mCRPC). In controlled clinical studies, 0.5% (10 of 2051) of patients experienced seizure, but patients with a history of or risk factors for seizure were excluded. Men with mCRPC and seizure risk factors have an estimated seizure rate of 2.8 per 100 patient-years without enzalutamide exposure. Objective: To assess seizure incidence in patients with seizure risk factors who were receiving enzalutamide for mCRPC. Design, Setting, and Participants: The UPWARD study (A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer Patients Treated With Enzalutamide) is an international, multicenter (73 sites in 20 countries), single-arm, open-label safety study in institutional practice. Data were collected from September 25, 2013, to February 1, 2016. Patients had at least 1 risk factor for seizure at baseline, including medications that lower seizure threshold, history of stroke, or history of seizure. Exclusion criteria included seizure (assessed by neurologic examination and history) requiring antiseizure medication within the past 12 months. Intervention: Treatment with oral enzalutamide, 160 mg/d. Main Outcomes and Measures: The primary end point was the proportion of evaluable patients with 1 or more independently confirmed seizures during the 4-month study period; evaluable patients were defined as those who had 3 months or more of treatment or 1 or more confirmed seizures during this treatment period. Results: Of 423 patients with mCRPC receiving enzalutamide, 366 were evaluated. At baseline, risk factors for seizure included medications that lowered seizure threshold (242 of 423 patients [57.2%]), history of brain injury (112 [26.5%]), and history of cerebrovascular accident or transient ischemic attack (94 [22.2%]). Four of the 366 evaluable patients (1.1%) had at least 1 confirmed seizure within 4 months of enzalutamide initiation, and 3 (0.8%) additional patients experienced a seizure within 4 months following the 4-month study period. The incidence of confirmed seizure was 2.6 per 100 patient-years (7 seizures). Of the 423 patients receiving enzalutamide, 357 (84.4%) experienced at least 1 treatment-emergent adverse event (an adverse event temporally related to the study treatment); 141 (33.3%) had at least 1 serious treatment-emergent adverse event, and 29 (6.9%) had at least 1 drug-related serious adverse event. Thirty-eight deaths (9.0%) were reported during treatment or within 30 days of drug discontinuation; 4 were considered possibly drug related. Conclusions and Relevance: Incidence of seizure is similar in patients with mCRPC and similar seizure risk factors with or without enzalutamide exposure. The risk profile presented, along with the previously established efficacy of enzalutamide, suggests that enzalutamide can benefit patients with a history of seizures or other predisposing factors, but each patient should be closely monitored for the duration of treatment.

Impact of Enzalutamide Compared with Bicalutamide on Quality of Life in Men with Metastatic Castration-resistant Prostate Cancer: Additional Analyses from the TERRAIN Randomised Clinical Trial.

BACKGROUND: Improving health-related quality of life (HRQoL) is an important goal in metastatic castration-resistant prostate cancer (mCRPC). OBJECTIVE: To examine the impact of enzalutamide versus bicalutamide on HRQoL in mCRPC. DESIGN, SETTING, AND PARTICIPANTS: TERRAIN is a multinational, phase 2, randomised, double-blind study in asymptomatic/mildly symptomatic men with mCRPC (ClinicalTrials.gov, NCT01288911). Patients were randomised (1:1) via an interactive voice and web response system to enzalutamide 160mg/d (n=184) or bicalutamide 50mg/d (n=191), with androgen deprivation therapy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: HRQoL was assessed using Functional Assessment of Cancer Therapy-Prostate (FACT-P), European Quality of Life 5-Domain Scale (EQ-5D), and Brief Pain Inventory, Short-form questionnaires every 12 wk. Primary and secondary analyses utilised mixed models for repeated measures and pattern mixture models, respectively. RESULTS AND LIMITATIONS: At 61 wk, 84 (46%) enzalutamide and 39 (20%) bicalutamide patients in the study were assessed. At 61 wk, changes from baseline favoured enzalutamide versus bicalutamide on three FACT-P domains in mixed models for repeated measures analyses and seven in pattern mixture models analyses. There were no differences in changes for EQ-5D index/visual analogue scale scores. Risk of first deterioration was lower with enzalutamide for FACT-P total (hazard ratio: 0.64, 95% confidence interval: 0.46-0.89, p=0.007), FACT-G total (hazard ratio: 0.70, 95% confidence interval: 0.50-0.98, p=0.04), PCS pain (hazard ratio: 0.74, 95% confidence interval: 0.54-1.00, p=0.048), and EQ-5D index (hazard ratio: 0.66, 95% confidence interval: 0.47-0.93, p=0.02) scores versus bicalutamide. Brief Pain Inventory, Short-form scores increased in both groups. There was no difference in time-to-pain progression. Study limitations include the exploratory nature of the HRQoL analyses, lack of multiple comparisons corrections, and unknown effects of anxiety/depression on HRQoL. CONCLUSIONS: In patients with asymptomatic/mildly symptomatic mCRPC, enzalutamide provides HRQoL benefit versus bicalutamide. PATIENT SUMMARY: Enzalutamide treatment was associated with better health-related quality of life in several domains versus bicalutamide in asymptomatic/mildly symptomatic metastatic castration-resistant prostate cancer. This likely relates to previously reported lower rates of symptomatic disease progression.

Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial.

PURPOSE: Enzalutamide, a potent oral androgen receptor inhibitor, improves survival in men with metastatic castration-resistant prostate cancer (CRPC) before and after chemotherapy. Bicalutamide, a nonsteroidal antiandrogen, is widely used to treat men with nonmetastatic or metastatic CRPC. The efficacy and safety of these drugs were compared in this randomized, double-blind, phase II study of men with CRPC. PATIENTS AND METHODS: A total of 396 men with nonmetastatic (n = 139) or metastatic (n = 257) CRPC were randomly assigned to enzalutamide 160 mg per day (n = 198) or bicalutamide 50 mg per day (n = 198). Androgen deprivation therapy was continued in both arms. The primary end point was progression-free survival (PFS). RESULTS: Enzalutamide reduced the risk of progression or death by 76% compared with bicalutamide (hazard ratio [HR], 0.24; 95% CI, 0.18 to 0.32; P < .001). Median PFS was 19.4 months with enzalutamide versus 5.7 months with bicalutamide. Enzalutamide resulted in significant improvements in all key secondary end points: time to prostate-specific antigen progression (HR, 0.19; 95% CI, 0.14 to 0.26; P < .001); proportion of patients with a ≥ 50% prostate-specific antigen response (81% v 31%; P < .001); and radiographic PFS in metastatic patients (HR, 0.32; 95% CI, 0.21 to 0.50; P < .001). Beneficial effects with enzalutamide were observed in both nonmetastatic and metastatic subgroups. The observed adverse event profile was consistent with that from phase III enzalutamide trials. CONCLUSION: Enzalutamide significantly reduced risk of prostate cancer progression or death compared with bicalutamide in patients with nonmetastatic or metastatic CRPC.

Construction and Validation of a Perceived Physical Literacy Instrument for Physical Education Teachers.

The purpose of this study was to construct and validate a "Perceived Physical Literacy Instrument" (PPLI) for physical education teachers. Based on literature review and focus group interviews, an 18-item instrument was developed for the initial tests. This self-report measure, using a 5-point Likert scale, formed the PPLI and was administered to 336 physical education teachers in Hong Kong. The sample was randomly split, and exploratory and confirmatory factor analyses resulted in a 9-item, 3-factor scale. Exploratory factor analysis (EFA) item loadings ranged from 0.69 to 0.87, and Cronbach's alpha ranged from 0.73 to 0.76. Confirmatory factor analysis (CFA) showed that the construct demonstrated good fit to the model. The PPLI thus appeared to be reliable and valid to measure the perceived physical literacy of physical education teachers. It is argued that the instrument can be used for both research and applied purposes and potential uses for the instrument in physical education, medical and health settings are discussed.

Difficulty with diagnosis of malignant pancreatic neoplasms coexisting with chronic pancreatitis.

Chronic pancreatitis is a relatively common disease. We encountered two different cases of belatedly demonstrated pancreatic carcinoma featuring underlying chronic pancreatitis. The first case was one that was highly suspected as that of a malignancy based upon imaging study, but unfortunately, it could not be confirmed by intra-operative cytology at that time. Following this, the surgeon elected to perform only conservative bypass surgery for obstructive biliary complication. Peritoneal carcinomatosis was later noted and the patient finally died. The second case, a malignant mucinous neoplasm, was falsely diagnosed as a pseudocyst, based upon the lesion's sonographic appearance and associated elevated serum amylase levels. After suffering repeated hemoptysis, the patient was found to exhibit lung metastasis and peritoneal seeding. We reviewed some of the literature, including those studies discussing chronic pancreatitis predisposing to a malignant change. These two case analyses illustrate clearly that the diagnosis for such conditions, which is simply based upon imagery or pathological considerations may end up being one of a mistaken malignancy. Some of our suggestions for the treatment of such malignancies as revealed herein include, total pancreatomy for univocal mass lesion, and needle aspiration of lesion-contained tissue for amylase, CA199 and CEA levels for a suspicious cystic pancreatic mass.

Sleep Trajectories of Women Undergoing Elective Cesarean Section: Effects on Body Weight and Psychological Well-Being.

BACKGROUND: After cesarean section (CS), women may be at great risk for sleep disturbance, but little is known about temporal changes in their sleep patterns and characteristics. We had two aims: 1) to identify distinct classes of sleep-disturbance trajectories in women considering elective CS from third-trimester pregnancy to 6 months post-CS and 2) to examine associations of sleep trajectories with body mass index (BMI), depressive symptoms, and fatigue scores. METHODS: We analyzed data from a prospective cohort study of 139 Taiwanese pregnant women who elected CS. Sleep components were assessed using the Pittsburgh Sleep Quality Index in third-trimester pregnancy, 1 day, 1 week, 1 month, and 6 months post-CS. Data were collected on depressive symptoms, fatigue symptoms, and BMI. Sleep-quality trajectories were identified by group-based trajectory modeling. RESULTS: We identified three distinct trajectories: stable poor sleep (50 women, 36.0%), progressively worse sleep (67 women, 48.2%), and persistently poor sleep (22 women, 15.8%). Poor sleep was significantly associated with pre-pregnancy BMI and more baseline (third-trimester pregnancy) depressive and fatigue symptoms. At 6 months post-CS, women classified as progressively worse or persistently poor sleepers showed a trend toward higher BMI (p<0.03), more depressive symptoms (p<0.001), and higher fatigue scores (p<0.001) than those with stable poor sleep. CONCLUSIONS: Women had three distinct sleep-disturbance trajectories before and after elective CS. These poor-sleep courses were associated with BMI and psychological well-being. Our findings suggest a need to continuously assess sleep quality among women considering elective CS and up to 6 months post-CS.

Gene delivery of endothelial nitric oxide synthase into nucleus tractus solitarii induces biphasic response in cardiovascular functions of hypertensive rats.

BACKGROUND: Nitric oxide (NO) plays an important role in central control of blood pressure (BP). An intrinsic defect in NO availability in brain nucleus contributes to the elevated BP in the spontaneously hypertensive rats (SHR). This study was aimed to investigate the effect of endothelial NO synthase (eNOS) gene delivery in the nucleus tractus solitarii (NTS) on the cardiovascular functions of SHR. METHODS: Adenovirus vectors encoding either eNOS (Ad-eNOS) or green fluorescent protein (Ad-GFP) were used for gene transfer study. The cardiovascular functions in SHR received NTS gene delivery that were monitored by an oscillometric device. RESULTS: Infection of neuronal cells with Ad-eNOS increased the nitrite production but decreased the level of superoxide anion (O(2)(-)), indicating that eNOS gene delivery increased NO availability. After microinjection into NTS, adenovirus-mediated GFP or eNOS expression was confirmed by fluorescence microscopy and immunohistochemical analysis. On days 3 to 14 after injection, a significant decrease in mean BP (MBP and heart rate (HR) was observed in Ad-eNOS-treated SHR, but not in Ad-GFP- or saline-treated SHR. Within this period, microinjection of the soluble guanylate cyclase inhibitor significantly reversed the Ad-eNOS-mediated depressor effect. However, on days 24 to 40, the MBP of Ad-eNOS-treated animals escalated, then returned to the normal range after day 50. The mechanism underlying the rebound of BP in Ad-eNOS-injected SHR remains to be elucidated. CONCLUSIONS: Intra-NTS eNOS gene delivery causes a depressor response in SHR, but a transient increase in MBP was observed after the Ad-eNOS-induced hypotension disappeared.

Neurofibroma with increased uptake of [F-18]-fluoro-2 deoxy-D-glucose interpreted as a metastatic lesion.

We report a patient with a solitary spinal neurofibroma in the posterior mediastinum interpreted as a metastatic tumor. A 46-year-old female with rectal cancer who had undergone operation and subsequent adjuvant chemotherapy two years previously was referred to our department for a follow-up whole body FDG-PET study. PET scan revealed a mass with increased uptake of FDG (SUV = 4.6) in the posterior mediastinum. MRI examination showed a dumbbell neurogenic tumor originating from the intercostal nerve at T6 level. A subsequent CT-guided biopsy demonstrated a neurofibroma.