Helicobacter pylori infection is not involved in the pathogenesis of either erosive or non-erosive gastro-oesophageal reflux disease

BACKGROUND: The majority of reflux patients have non-erosive reflux disease. AIM: To evaluate the influence of Helicobacter pylori on oesophageal acid exposure in patients with both non-erosive and erosive reflux disease and in a group of controls. The pattern and distribution of chronic gastritis were also assessed. METHODS: One hundred and twelve consecutive patients with symptoms of gastro-oesophageal reflux disease agreed to undergo both upper gastrointestinal endoscopy and 24-h oesophageal pH-metry. Patients were grouped as H. pylori-positive or H. pylori-negative on the basis of both CLO-test and histology, and as cases with or without oesophagitis on the basis of endoscopy. The controls consisted of 19 subjects without reflux symptoms and with normal endoscopy and oesophageal pH-metry. RESULTS: H. pylori was positive in 35 patients (31%) and in six controls (31%); oesophagitis was found in 44 patients (39%) and non-erosive reflux disease in 68 (61%). The prevalence of chronic gastritis in the antrum and corpus was higher in H. pylori-positive than in H. pylori-negative patients (P < 0.001), but was more frequently mild (P < 0.001) than moderate or severe. The percentage total time the oesophageal pH < 4.0 was higher in patients than in controls (P < 0.008-0.001), but there was no difference between H. pylori-positive and H. pylori-negative patients (12.3% vs. 12%, P = 0.43) or H. pylori-positive and H. pylori-negative controls (1.07% vs. 1.47%, P = 0.19). CONCLUSIONS: H. pylori infection had the same prevalence in reflux patients and in controls. It did not affect oesophageal acid exposure, as there was no difference between H. pylori-positive and H. pylori-negative individuals. The high prevalence of mild body gastritis in H. pylori-positive patients suggests that H. pylori eradication is unlikely to lead to gastric functional recovery, which might precipitate or worsen symptoms and lesions in patients with gastro-oesophageal reflux disease.     

Repair of pulmonary artery sling by reimplantation without cardiopulmonary bypass

A 20-month-old girl successfully underwent repair of pulmonary artery sling through a median sternotomy by division of the left pulmonary artery and its reimplantation into the main pulmonary artery without cardiopulmonary bypass or tracheal reconstruction. The patient is doing well on 18 months follow-up with unobstructed pulmonary blood flow and dramatic reduction of tracheal stenosis. Simple repair of pulmonary artery sling is feasible with good results in selected cases without tracheomalacia.     

Lymphocyte changes in beta-thalassaemia major.

Lymphocyte subpopulations were studied in 20 hypertransfused patients with beta-thalassaemia major, some of whom had been splenectomised. B-lymphocytes were normal but T-lymphocytes were decreased in all patients. The T-cell count was lower in the splenectomised patients than in the nonsplenectomised ones. In the former, the active rosette-forming lymphocytes were also diminished, but the difference was not significant. In all patients the percentage of null cells was greater and the activity of K-cells increased compared with controls.     

Effect of the synthetic retinoid fenretinide on circulating free prostate-specific antigen, insulin-like growth factor-I, and insulin-like growth factor binding protein-3 levels in men with superficial bladder cancer.

PURPOSE: Fenretinide (4-HPR) is a synthetic retinoid that has shown a preventive activity in prostate cancer animal models. EXPERIMENTAL DESIGN: We measured the changes in total and free prostate-specific antigen (PSA) and its association with insulin-like growth factor I (IGF-I) and IGFBP-3 levels after 1 year of treatment in 24 subjects given 4-HPR and 24 control subjects enrolled in a randomized bladder cancer prevention trial. RESULTS: No significant effect of 4-HPR was observed on total and free fraction of PSA levels. The median percentage [95 confidence interval (95% CI)] change for % free PSA and total PSA in the 4-HPR and the control group were, respectively, 7.6 (95% CI, -4.0 to 69.3) versus 5.1 (95% CI, -21.4 to 59.8) and -7.8 (95% CI, -18.2 to 52.5) versus -12.3 (95% CI, -44.6 to 9.6). However, in patients ages <60 years, there was a trend to an increase of total free PSA and % free PSA after treatment with 4-HPR that was different from a trend to a decrease in the control group (P = 0.002 and 0.052, respectively). The interaction between age and treatment was statistically significant on free PSA (P = 0.001). A similar pattern was noted with smoking status (P = 0.011 for the interaction on free PSA). No association was observed between PSA levels and IGF-I or IGFBP-3 levels. CONCLUSIONS: We conclude that 4-HPR has no significant effect on circulating PSA, but it increases significantly free PSA levels in subjects younger than 60 years and in nonsmokers. These effects might support an activity in prostate cancer prevention but further studies are required.     

Combination drug regimens for metastatic clear cell renal cell carcinoma

Renal cell carcinomas (RCC) make up about 90% of kidney cancers, of which 80% are of the clear cell subtype. About 20% of patients are already metastatic at the time of diagnosis. Initial treatment is often cytoreductive nephrectomy, but systemic therapy is required for advanced RCC. Single agent targeted therapies are moderately toxic and only somewhat effective, leading to development of immunotherapies and combination therapies. This review identifies limitations of monotherapies for metastatic renal cell carcinoma, discusses recent advances in combination therapies, and highlights therapeutic options under development. The goal behind combining various modalities of systemic therapy is to potentiate a synergistic antitumor effect. However, combining targeted therapies may cause increased toxicity. The initial attempts to create therapeutic combinations based on inhibition of the vascular endothelial growth factor or mammalian target of rapamycin pathways were largely unsuccessful in achieving a profile of increased synergy without increased toxicity. To date, five combination therapies have been approved by the U.S. Food and Drug Administration, with the most recently approved therapies being a combination of checkpoint inhibition plus targeted therapy. Several other combination therapies are under development, including some in the phase 3 stage. The new wave of combination therapies for metastatic RCC has the potential to increase response rates and improve survival outcomes while maintaining tolerable side effect profiles.     

Feasibility of health-related quality of life (HRQoL) assessment for cancer patients using electronic patient-reported outcome (ePRO) in daily clinical practice

Quality of Life Research - Routine Electronic Monitoring of Health-Related Quality of Life (HRQoL) (REMOQOL) in clinical care with real-time feedback to physicians could help to enhance...     

Understanding the Enablers and Barriers to Appropriate Infants and Young Child Feeding Practices in India: A Systematic Review

Despite efforts to promote infant and young child feeding (IYCF) practices, there is no collective review of evidence on IYCF enablers and barriers in India. This review was conducted using 2015 Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines. Six computerized bibliographic databases, Scopus, PubMed, PsycINFO, CINAHL, Embase, and Ovid MEDLINE, were searched for published studies on factors associated with IYCF practices in India from 1 January 1993, to 30 April 2020. IYCF practices examined were early initiation of breastfeeding, exclusive breastfeeding, continued breastfeeding at one year, introduction to solid semi-solid or soft foods, minimum dietary diversity, minimum meal frequency, minimum acceptable diet, continued breastfeeding at two years, predominant breastfeeding, and bottle feeding. In total, 6968 articles were retrieved, and 46 studies met the inclusion criteria. The common enablers of IYCF were higher maternal socioeconomic status (SES) and more frequent antenatal care visits (ANC) (≥3). Common barriers to IYCF practices were low SES and less frequent ANC. The review showed that the factors associated with IYCF practices in India are largely modifiable and multi-factorial. Improving IYCF practices would require the adoption of both facilities- and community-based policy interventions at the subnational and national levels in India.     

Mixed binary-continuous copula regression models with application to adverse birth outcomes

Bivariate copula regression allows for the flexible combination of two arbitrary, continuous marginal distributions with regression effects being placed on potentially all parameters of the resulting bivariate joint response distribution. Motivated by the risk factors for adverse birth outcomes, many of which are dichotomous, we consider mixed binary-continuous responses that extend the bivariate continuous framework to the situation where one response variable is discrete (more precisely, binary) whereas the other response remains continuous. Utilizing the latent continuous representation of binary regression models, we implement a penalized likelihood–based approach for the resulting class of copula regression models and employ it in the context of modeling gestational age and the presence/absence of low birth weight. The analysis demonstrates the advantage of the flexible specification of regression impacts including nonlinear effects of continuous covariates and spatial effects. Our results imply that racial and spatial inequalities in the risk factors for infant mortality are even greater than previously suggested.     

Transparency and credibility of industry-sponsored clinical trial publications: a survey of journal editors

Objective: To examine how medical journal editors perceive changes in transparency and credibility of industry-sponsored clinical trial publications over a 5 year period (2010 to 2015).

Methods: From July to September 2015, a survey link was emailed to journal editors identified from the Thomson Reuters registry. Editors ranked their perception of: a) change in transparency and credibility of industry-sponsored clinical trial publications; b) 8 “Publication Best Practices” and the impact of each on transparency; and c) the importance and adoption of the previously published “10 Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research”.

Results: Of 510 editors who opened the survey, the analysis pool comprised a total of 293 editors. The majority of respondents reported their location as the US (46%) or EU (45%) and most commonly reported editorial titles were deputy/assistant editor (36%), editor-in-chief (35%) and section editor (24%). More editors reported improved versus worsened transparency (63.5% vs. 6.1%) and credibility (53.2% vs. 10.4%). Best practices that contributed most to improved transparency were “disclosure of the study sponsor” and “registration and posting of trial results”. Respondents ranked the importance of nine recommendations as moderate or extremely important, and adoption of all recommendations was ranked minimal to moderate.

Conclusions: The 293 editors who responded perceived an improvement in the transparency and credibility of industry-sponsored publications from 2010 to 2015. Confirmation of the importance of 9/10 recommendations by the respondents was encouraging. Yet, low adoption rates suggest that additional work is required by all stakeholders to improve best practices, transparency and credibility.     

Feasibility of an Internet-based positive psychological intervention for hemodialysis patients with symptoms of depression

ABSTRACT

Background: Depression is a pervasive psychological issue facing hemodialysis (HD) patients. Novel technology-based treatment strategies that deploy psychology-based interventions have not been the focus for therapy and few published studies exist. The aim of the current trial is to determine the feasibility and acceptability of an Internet-based positive psychological intervention in HD patients with comorbid depressive symptoms. Methods: HD patients (n = 14) with elevated symptoms of depression were enrolled in a single-arm pre-post trial with clinical assessments at baseline and immediately post intervention. Chairside during regularly scheduled HD treatment, patients utilized a web browser to complete online modules promoting skills for increasing positive emotion over a 5-week period using Apple IPads. Targeted skills included noting of daily positive events, gratitude, positive reappraisal, acts of kindness, and mindfulness/meditation. Results: Twelve of 14 patients completed the program for an 85.7% retention rate. Participants felt satisfied with each session and offered consistently positive feedback. On average, participants visited the website 3.5 times per week. Significant improvements were evident for depressive symptoms (15.3 vs. 10.9; p = 0.04), as per the Center for Epidemiological Studies Depression Scale. Conclusions: An innovative Internet-based positive psychological intervention represents a feasible and useful therapeutic option for HD patients with depressive symptoms.