A Phase 1a/1b Study of Fostroxacitabine Bralpamide (Fostrox) Monotherapy in Hepatocellular Carcinoma and Solid Tumor Liver Metastases.

Purpose: To evaluate safety, preliminary efficacy, pharmacokinetics, and pharmacodynamics, of fostroxacitabine bralpamide (fostrox, MIV-818), a novel oral troxacitabine nucleotide prodrug designed to direct exposure to the liver, while minimizing systemic toxicity.

Patients And Methods: Fostrox monotherapy was administered in an open-label, single-arm, first-in-human, phase 1a/1b study, in patients with hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma, or solid tumor liver metastases. The first part (1a) consisted of intra/inter-patient escalating doses (3 mg to 70 mg) QD for up to 5 days, and the second part (1b), doses of 40 mg QD for 5 days, in 21-day cycles.

Electronic cigarettes for smoking cessation.

Background: Electronic cigarettes (ECs) are handheld electronic vaping devices which produce an aerosol by heating an e-liquid. People who smoke, healthcare providers and regulators want to know if ECs can help people quit smoking, and if they are safe to use for this purpose. This is a review update conducted as part of a living systematic review.

Systematic review of medical literature for medicolegal claims and complaints involving neonates.

Importance: Complaints and malpractice claims by families on the care of their babies are pertinent issue. Beyond just the financial implications, it involves harm to babies and distress to parents.

Objective: The aim was to review published reports of complaints by families on the care of their babies in the neonatal units in order to understand the nature of these complaints and the areas of care that they relate to.

A support package for parents of excessively crying infants: development and feasibility study.

Background: Around 20% of 1- to 4-month-old infants cry for long periods without an apparent reason. Traditionally, this was attributed to gastrointestinal disorder ('colic'), but evidence shows that just 5% of infants cry a lot because of organic disturbances; in most cases, the crying is attributable to normal developmental processes. This has led to a focus on the impact of the crying on parents.

Parental and health professional evaluations of a support service for parents of excessively crying infants.

Background: The 'Surviving Crying' study was designed to develop and provisionally evaluate a support service for parents of excessively crying babies, including its suitability for use in the United Kingdom (UK) National Health Service (NHS). The resulting service includes three materials: a website, a printed booklet, and a Cognitive Behaviour Therapy (CBT) programme delivered to parents by a qualified professional. This study aimed to measure whether parents used the materials and to obtain parents' and NHS professionals' evaluations of whether they are fit for purpose.

Treatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial.

Background: Irritable bowel syndrome with diarrhoea (IBS-D) affects up to 4% of the general population. Symptoms include frequent, loose, or watery stools with associated urgency, resulting in marked reduction of quality of life and loss of work productivity. Ondansetron, a 5HT receptor antagonist, has had an excellent safety record for over 20 years as an antiemetic, yet is not widely used in the treatment of IBS-D.

The Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease (PSP-CKD) Study: A Cluster Randomized Trial in Primary Care.

Background: Most patients with CKD are managed in the community. Whether nurse-led CKD management programs improve outcomes in patients with CKD in primary care is unclear.

Methods: To assess the effect of such a program on the rate of renal function decline in patients with CKD (stages 3-5) in primary care in the United Kingdom, we conducted a cluster randomized trial, the Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease study.

Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or stage T1 adenocarcinoma in Barrett's esophagus: a randomized pilot study (BRIDE).

Background And Aims: Endoscopic resection (ER) is safe and effective for Barrett's esophagus (BE) containing high-grade dysplasia (HGD) or mucosal adenocarcinoma (T1A). The risk of metachronous neoplasia is reduced by ablation of residual BE by using radiofrequency ablation (RFA) or argon plasma coagulation (APC). These have not been compared directly.

Unequal cluster sizes in stepped-wedge cluster randomised trials: a systematic review.

Objectives: To investigate the extent to which cluster sizes vary in stepped-wedge cluster randomised trials (SW-CRT) and whether any variability is accounted for during the sample size calculation and analysis of these trials.

Setting: Any, not limited to healthcare settings.

Participants: Any taking part in an SW-CRT published up to March 2016.

A Phase I study to determine the pharmacokinetic profile, safety and tolerability of sildenafil (Revatio ) in cardiac surgery: the REVAKI-1 study.

Aims: Acute kidney injury (AKI) is a common and severe complication of cardiac surgery. There is no effective prevention or treatment. Sildenafil citrate (Revatio , Pfizer Inc.

Cluster randomised trial of a tailored intervention to improve the management of overweight and obesity in primary care in England.

Background: Tailoring is a frequent component of approaches for implementing clinical practice guidelines, although evidence on how to maximise the effectiveness of tailoring is limited. In England, overweight and obesity are common, and national guidelines have been produced by the National Institute for Health and Care Excellence. However, the guidelines are not routinely followed in primary care.

A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study.

Background: Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients. The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre randomised controlled trial to evaluate routine home enteral nutrition in these patients.

Methods: Patients undergoing oesophagectomy or total gastrectomy were randomised to either six weeks of home feeding through a jejunostomy (intervention), or treatment as usual (control).

Can we convert between outcome measures of disability for chronic low back pain?

Study Design: Retrospective database analysis.

Objective: A range of patient-reported outcomes were used to measure disability due to low back pain. There is not a single back pain disability measurement commonly used in all randomized controlled trials.

Colloid cyst of velum interpositum: a rare finding.

The authors present the case of a child with a colloid cyst of the velum interpositum. To the best of the authors' knowledge, this is the first reported case in the pediatric literature and only the second reported case to date. The patient was of an 11-year-old boy in whom this lesion was found after a minor head injury.

Lead uptake and translocation by willows in pot and field experiments.

Plant growth and lead (Pb) uptake by seven willow varieties were investigated in pot and field experiments to assess the suitability of willows for phytoremediation of Pb at heavily contaminated sites such as skeet ranges. Differences in uptake and translocation of Pb in Salix were observed between pot and field experiments. In the pot experiment, willows grown in Pb-contaminated field soil for 6 months showed tolerance to very high soil Pb concentration (21,360 mg kg(-1)), and with the addition of EDTA were able to take up and translocate more than 1000 mg kg(-1) Pb into above-ground tissues.

Hydroponic screening of willows (Salix L.) for lead tolerance and accumulation.

Lead tolerance and accumulation in five willow clones were investigated using a nutrient film technique. Plants were exposed to 0, 48, 121, 169, or 241 microM Pb for 14 days. Tolerance indices (TI) and critical toxicity thresholds (EC50) were determined for five willow clones.

Goserelin acetate 10.8 mg plus iron versus iron monotherapy prior to surgery in premenopausal women with iron-deficiency anemia due to uterine leiomyomas: results from a Phase III, randomized, multicenter, double-blind, controlled trial.

Background: Women with symptomatic uterine leiomyomas (fibroids) may have iron-deficiency anemia (IDA); therefore, surgery places them at risk of blood-borne morbidity from perioperative transfusions. Such women might benefit from a preoperative treatment that restores hematologic normality and alleviates fibroid symptoms.

Objective: The purpose of this study was to examine the effects of a single preoperative depot injection of goserelin acetate plus iron treatment compared with iron monotherapy, in premenopausal women with IDA due to uterine leiomyomas.

Is prostate-specific antigen a valid surrogate end point for survival in hormonally treated patients with metastatic prostate cancer? Joint research of the European Organisation for Research and Treatment of Cancer, the Limburgs Universitair Centrum, and AstraZeneca Pharmaceuticals.

Purpose: The long duration of phase III clinical trials of overall survival (OS) slows down the treatment-development process. It could be shortened by using surrogate end points. Prostate-specific antigen (PSA) is the most studied biomarker in prostate cancer (PCa).

Bicalutamide 150 mg in addition to standard care in patients with localized or locally advanced prostate cancer: results from the second analysis of the early prostate cancer program at median followup of 5.4 years.

Purpose: We evaluated the efficacy and tolerability of 150 mg bicalutamide daily given in addition to standard care, in patients with localized or locally advanced prostate cancer.

Materials And Methods: The bicalutamide Early Prostate Cancer program consists of 3 randomized, double blind, placebo controlled trials prospectively designed for combined analysis. A total of 8,113 men with T1b-T4, M0, any N (N0 in 1 trial) prostate cancer were randomized to bicalutamide 150 mg/day (4,052) or placebo (4,061) in addition to standard care (radical prostatectomy, radiotherapy or watchful waiting).