ePHex: a phase 3, double-blind, placebo-controlled, randomized study to evaluate long-term efficacy and safety of Oxalobacter formigenes in patients with primary hyperoxaluria.

Background: Primary hyperoxalurias (PHs) are rare genetic diseases that increase the endogenous level of oxalate, a waste metabolite excreted predominantly by the kidneys and also the gut. Treatments aim to improve oxalate excretion, or reduce oxalate generation, to prevent kidney function deterioration. Oxalobacter formigenes is an oxalate metabolizing bacterium.

Plasma oxalate and eGFR are correlated in primary hyperoxaluria patients with maintained kidney function-data from three placebo-controlled studies.

Background: In patients with primary hyperoxaluria (PH), endogenous oxalate overproduction increases urinary oxalate excretion, leading to compromised kidney function and often kidney failure. Highly elevated plasma oxalate (Pox) is associated with systemic oxalate deposition in patients with PH and severe chronic kidney disease (CKD). The relationship between Pox and estimated glomerular filtration rate (eGFR) in patients with preserved kidney function, however, is not well established.

Effects of Oxalobacter formigenes in subjects with primary hyperoxaluria Type 1 and end-stage renal disease: a Phase II study.

Background: In primary hyperoxaluria Type 1 (PH1), endogenous oxalate overproduction significantly elevates urinary oxalate excretion, resulting in recurrent urolithiasis and/or progressive nephrocalcinosis and often early end-stage renal disease (ESRD). In ESRD, dialysis cannot sufficiently remove oxalate; plasma oxalate (Pox) increases markedly, inducing systemic oxalate deposition (oxalosis) and often death. Interventions to reduce Pox in PH1 subjects with ESRD could have significant clinical impact.

Impact of CINV in earlier cycles on CINV and chemotherapy regimen modification in subsequent cycles in Asia Pacific clinical practice.

Purpose: We sought to describe the impact of chemotherapy-induced nausea and vomiting (CINV) in prior cycles on CINV and chemotherapy regimen modification in subsequent cycles.

Methods: Eligible patients in this multinational prospective observational study were adults (≥18 years old) receiving their first single-day highly or moderately emetogenic chemotherapy (HEC or MEC). Multivariate logistic regression was used to assess the impact of CINV in prior cycles on CINV in subsequent cycles.

Antiemetic therapy in Asia Pacific countries for patients receiving moderately and highly emetogenic chemotherapy--a descriptive analysis of practice patterns, antiemetic quality of care, and use of antiemetic guidelines.

Purpose: This paper reports prescribing patterns for prophylaxis of chemotherapy-induced nausea and vomiting (CINV) after highly or moderately emetogenic chemotherapy (HEC or MEC) for cancer in six Asia Pacific countries.

Methods: In a prospective noninterventional study, 31 sites in Australia, China, India, Singapore, South Korea, and Taiwan recorded details of CINV prophylaxis for the acute phase (first 24 h) and delayed phase (days 2-5) after single-day HEC or MEC for adult patients. Additional information on CINV prophylactic medications was collected from 6-day patient diaries.

Incidence and predictors of anticipatory nausea and vomiting in Asia Pacific clinical practice--a longitudinal analysis.

Purpose: Some patients experience nausea and/or vomiting (NV) before receipt of chemotherapy. Our objective was to evaluate the impact of prior chemotherapy-induced NV (CINV) on the incidence of anticipatory NV in later cycles.

Methods: This multicenter, prospective non-interventional study enrolled chemotherapy-naïve adults scheduled to receive highly or moderately emetogenic chemotherapy (HEC/MEC) for cancer in six Asia Pacific countries, excluding those with emesis within 24 h before cycle 1 chemotherapy.

Skin toxicity and quality of life in patients with metastatic colorectal cancer during first-line panitumumab plus FOLFIRI treatment in a single-arm phase II study.

Background: Integument-related toxicities are common during epidermal growth factor receptor (EGFR)-targeted therapy. Panitumumab is a fully human monoclonal antibody targeting the EGFR that significantly improves progression-free survival when added to chemotherapy in patients with metastatic colorectal cancer who have wild-type (WT) KRAS tumours. Primary efficacy and tolerability results from a phase II single-arm study of first-line panitumumab plus FOLFIRI in patients with metastatic colorectal cancer have been reported.

Frequency-domain near-infrared spectroscopy of the uterine cervix during regular pregnancies.

Preterm labor is a common obstetric complication. Clinical evaluation of cervical ripening to predict preterm labor is very inaccurate. We used frequency-domain near-infrared spectroscopy (FD-NIRS) to non-invasively investigate the changes of the optical properties (i.

The effects of discontinuing cinacalcet at the time of kidney transplantation.

Background. The calcimimetic, cinacalcet, is approved for treating secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on dialysis. Biochemical profiles and clinical outcomes in patients discontinuing cinacalcet at kidney transplantation have not been previously described.

Cinacalcet and achievement of the NKF/K-DOQI recommended target values for bone and mineral metabolism in real-world clinical practice--the ECHO observational study.

Background: The use and effectiveness of cinacalcet in 'real-world' clinical practice was investigated in a pan-European observational study in dialysis patients with secondary hyperparathyroidism (SHPT) of varying severity.

Methods: Adult patients with chronic kidney disease on dialysis who had initiated cinacalcet treatment were enrolled. Data were collected 6 months before initiating cinacalcet, at baseline (initiation of cinacalcet) and up to 12 months after cinacalcet initiation.

Optical properties of the breast during spontaneous and birth control pill-mediated menstrual cycles.

Mastodynia is correlated with the menstrual cycle. Using frequency-domain near-infrared spectroscopy (FD-NIRS), we investigated changes in breast perfusion in women who were or were not using hormonal contraception. Healthy volunteers, on or not on hormonal contraception, were examined.

Optical properties, physiologic parameters and tissue composition of the human uterine cervix as a function of hormonal status.

The influence of sex hormones on the human uterine cervix is likely to be important in the process of cervical ripening. Frequency domain near-infrared spectroscopy (FD-NIRS) was used to investigate non-invasively the changes in the optical properties that reflect physiologic parameters and tissue composition of the uterine cervix in the different phases of the menstrual cycle. Twenty premenopausal and nine postmenopausal women were examined.

Frequency domain near-infrared spectroscopy of the uterine cervix during cervical ripening.

Objective: Preterm labor is a common obstetric complication. Clinical evaluation of cervical ripening to predict preterm labor has a substantial inter- and intraobserver variability. We used frequency domain near-infrared spectroscopy (FD-NIRS) to non-invasively investigate the changes of the optical properties (i.

Vaccination priorities.

Selection of immunizations should be based on requirements and on risk of infection. According to the International Health Regulations, many countries require yellow fever vaccination and proof thereof as the International Certificate of vaccination. Additionally selected countries require proof of vaccination against cholera and meningococcal disease.

Travel epidemiology--a global perspective.

In order to have a rational approach to necessary preventive measures it is essential to know the health risks. The 80 million travellers each year with destinations in Africa, Asia, Latin America, Pacific Islands and remote areas in Eastern Europe are exposed to a broad range of pathogens that are rarely encountered at home. The risk depends on the degree of endemicity in the area visited, the duration of stay, the individual behaviour and the preventive measures taken.