Background: In 2020 there were 623 known TB infections in the Netherlands according to the Dutch ministry of health (RIVM). About 4% were located in bones and joints. The incidence of Multi Drug Resistant (MDR) TB in The Netherlands is about 1%.
View Article and Find Full Text PDFA 16-year-old male patient with no known medical history presented at the Emergency Department (ED) with a 2-day history of pain and swelling in his right hemiscrotum. He was diagnosed with non-bacterial epididymitis and discharged home with medical advice. Six days after being diagnosed, the pain and swelling worsened and he was seen by a general practitioner who concluded that the symptoms were attributable to the previously diagnosed epididymitis.
View Article and Find Full Text PDFAJNR Am J Neuroradiol
December 2011
Background And Purpose: Although the number of enhancing lesions is the typical outcome measure of choice in clinical trials in MS, a potentially more sensitive and statistically more powerful outcome measure is the volume of enhancing lesions. In this study, we assessed the distribution and statistical power of the volume of enhancing brain lesions as an outcome measure by means of their required sample size, and we compared the results with the number of enhancing lesions.
Material And Methods: First, a literature search was performed to compare the effects of treatment on the number and volume of enhancing lesions.
Interferon-β (IFNβ) therapy is effective in approximately half of the patients with relapsing-remitting multiple sclerosis (RRMS). Clinical non-responders were characterized by an increased expression of IFN response genes before the start of therapy, and a lack of a pharmacologically induced increase in IFN response gene activity. Because Interferon Regulatory Factor 5 (IRF5) is a master regulator of IFN-activity, we carried out a candidate gene study of IRF5 gene variants in relation to the pharmacological and clinical response upon IFNβ treatment.
View Article and Find Full Text PDFObjective: To compare long-interval T2-weighted subtraction (T2w-Sub) imaging with monthly gadolinium-enhanced T1-weighted (Gd-T1w) imaging for (1) detection of active lesions, (2) assessment of treatment efficacy, and (3) statistical power, in a multiple sclerosis (MS), phase 2, clinical trial setting.
Methods: Magnetic resonance imaging (MRI) data over 9 months from 120 patients (61 treatment, 59 placebo) from the oral temsirolimus trial were used. T2w-Sub images were scored for active lesions, independent of the original reading of the monthly Gd-T1w images.
Magnetization transfer ratio (MTR) is a sensitive parameter to quantify the integrity of myelinated white matter in patients with multiple sclerosis. Lesional MTR decreases in the acute phase due to demyelination, and subsequently shows recovery depending on the degree of remyelination in the absence of axonal loss. Recovery of average lesion MTR therefore might prove a viable outcome measure to assess the effect of remyelinating agents.
View Article and Find Full Text PDFIntroduction: Cerebral atrophy is a compound measure of the neurodegenerative component of multiple sclerosis (MS) and a conceivable outcome measure for clinical trials monitoring the effect of neuroprotective agents. In this study, we evaluate the rate of cerebral atrophy in a 6-month period, investigate the predictive and explanatory value of other magnetic resonance imaging (MRI) measures in relation to cerebral atrophy, and determine sample sizes for future short-term clinical trials using cerebral atrophy as primary outcome measure.
Methods: One hundred thirty-five relapsing-remitting multiple sclerosis patients underwent six monthly MRI scans from which the percentage brain volume change (PBVC) and the number and volume of gadolinium (Gd)-enhancing lesions, T2 lesions, and persistent black holes (PBH) were determined.
Background: A statistical distribution describing the number of new enhancing lesions seen on MRI in patients with MS is of great importance for improving the statistical methodology of clinical trials using new enhancing lesions as outcome measure. We examined whether there are superior alternatives for the currently proposed negative binomial (NB) distribution.
Objective: To determine the optimal statistical distribution describing new enhancing lesion counts from a selection of six conceivable models, and to assess the effect on the distribution of a treatment effect, varying follow-up duration and selection for activity at baseline.
Background: MRI is often used as primary outcome measure in phase II clinical trials in multiple sclerosis (MS). Since persistent T1 hypointense lesions are a surrogate parameter for axonal damage and demyelination, they may serve as a marker for monitoring the efficacy of neuroprotective drugs. At present, a power analysis using black hole (BH) evolution as primary outcome measure has not been performed.
View Article and Find Full Text PDF