Clinical trials are an important part of clinical research. The conduction of clinical trials is strictly regulated and has to comply with an approved protocol. Local regulatory authorities, independent ethic committees, sponsors of clinical trials as well as the investigators are involved from the submission until the very end of the trial. All clinical trials performed in the Czech Republic have to be approved by the State Institute for Drug Control and by the Ethics Committee. The regulatory bodies and independent ethics committees evaluate and continuously supervise the justification and protocol of the clinical trial, quality of the investigational medicinal products and, primarily, the safety of the participants (patients and/or healthy volunteers) in clinical trials. In the Czech Republic there are many advanced clinical research centres, either located in private practices or within hospitals. The investigators are able to conduct a wide variety of clinical trials and recruit a high number of subjects for the trials, as well as to comply with the Good Clinical Practice guidelines and other regulatory requirements. The aim of this article is to summarise the current situation of clinical trials in the Czech Republic as well as the opportunities for getting involved in clinical trials and obligations arising for health professionals from such an involvement.

• MeSH
• biomedicínský výzkum normy   trendy   MeSH
• etické komise MeSH
• klinické zkoušky jako téma metody   normy   trendy   MeSH
• lidé MeSH
• testované léky aplikace a dávkování   MeSH
• vakcíny aplikace a dávkování   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Česká republika MeSH
• Názvy látek
• testované léky MeSH
• vakcíny MeSH

Ischemic heart disease is the most frequent cause of both serious morbidity and mortality of adult population in developed countries. The main aim of the study was to carry out the analysis of general practitioners (GP) prescription of evidence-based therapy in patients after myocardial infarction (MI). Data were retrospectively collected in 2011, by a single application with the help of software that GPs use in their surgeries. All patients of a particular GP who had MI in their history and who were at the time of data collection treated only by GPs (not by the specialists of internal medicine or cardiology) were always included. Four hundred ninety one patients were included in the study. The average age was 70.7 (+/- 11.6) and 69.2% of the involved patients were men. Seventy nine percent of patients used beta-blockers, 80% antiplatelet drugs, 77% statins and 79% used angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEIs/ARBs). Forty four percent of patients used drugs from all four groups. The significant prescription decrease was proved in all four groups in dependence on patients' age (p < 0.05). Although the evidence-based medicine usage in patients after MI in the Czech Republic is comparable to other countries, it is not optimal. More intensive involvement of pharmacists in the care of patients after MI would further improve the situation.

• MeSH
• dospělí MeSH
• infarkt myokardu farmakoterapie   MeSH
• lékařské předpisy MeSH
• lidé středního věku MeSH
• lidé MeSH
• medicína založená na důkazech * MeSH
• praktičtí lékaři * MeSH
• průřezové studie MeSH
• retrospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika MeSH

BACKGROUND: Maternal substance use can pose a risk to the fetal health. We studied the background characteristics of women with substance use disorders (SUDs) and selected neonatal outcomes in their children. MATERIAL AND METHODS: A database-linkage study was performed. The sample consisted of pregnant women with a SUD during pregnancy (ICD-10 diagnosis F10-F19 except F17, n = 1710), women not diagnosed with a SUD (n = 1,511,310) in Czechia in 2000-2014, and their children. The monitored neonatal outcomes were gestational age, birth weight, preterm birth, and small-for-gestational age (SGA). Binary logistic regression adjusted for age, marital status, education, concurrent substance use, and prenatal care was performed. RESULTS: Women with illicit SUDs were younger, more often unmarried, with a lower level of education, a higher abortion rate, a higher smoking rate, and lower compliance to prenatal care than women with a SUD related to alcohol, or sedatives and hypnotics (SH). Women with a SUD had worse socioeconomic situations, poorer pregnancy care, and worse neonatal outcomes than women without a SUD. After adjustment, we found no difference in SGA between the illicit SUD groups and the alcohol and the SH groups. The newborns from all SUD groups had a higher risk of SGA when compared to women without a SUD. However after adjustment, the difference remained significant just in the alcohol group (OR = 1.9, 95 % CI = 1.4-2.6). CONCLUSION: Mother's SUD during pregnancy increased risk of fetal growth restriction as measured by SGA. The role of maternal socioeconomic and lifestyle factors for the risk of SGA was substantial.

• Klíčová slova
• Growth restriction, Health registries, Neonatal outcomes, Pregnancy, Prenatal exposure, SGA, Substance use,
• MeSH
• dítě MeSH
• dospělí MeSH
• hypotrofický novorozenec fyziologie   MeSH
• komplikace těhotenství ekonomika   epidemiologie   MeSH
• lidé MeSH
• novorozenec MeSH
• porodní hmotnost účinky léků   fyziologie   MeSH
• poruchy spojené s užíváním psychoaktivních látek ekonomika   epidemiologie   MeSH
• předčasný porod ekonomika   epidemiologie   MeSH
• prenatální péče ekonomika   MeSH
• registrace * MeSH
• rizikové faktory MeSH
• růstová retardace plodu ekonomika   epidemiologie   MeSH
• socioekonomické faktory * MeSH
• těhotenství MeSH
• výsledek těhotenství ekonomika   epidemiologie   MeSH
• zpožděný efekt prenatální expozice ekonomika   epidemiologie   MeSH
• Check Tag
• dítě MeSH
• dospělí MeSH
• lidé MeSH
• novorozenec MeSH
• těhotenství MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika epidemiologie   MeSH

OBJECTIVE: One of the most important threats of current medicine is the spread of multiresistant Gram-negative bacteria. We report here data from a six-month prevalence study on carbapenemase-producing K. pneumoniae and E. coli performed in Czech hospitals participating on European Survey on Carbapenemase-Producing Enterobacteriaceae (EuSCAPE). METHODS: Ten hospitals covering all regions of the Czech Republic were selected. During the study period (1st November 2013 to 30th April 2014), first ten carbapenem non-susceptible isolates of K. pneumoniae or E. coli isolated from non-surveillance specimens (i.e., blood, lower respiratory tract secretions, urine, puncture fluids, and wound secretions) of single successive patients were collected. Successive carbapenem-susceptible isolates of the same species were also preserved as controls. Susceptibility to 15 antibiotics was determined using EUCAST recommendations. Carbapenemase activity was detected by MALDI-TOF MS meropenem hydrolysis assay. Positive isolates were subjected for molecular typing (multi-locus sequence typing, identification of carbapenemase gene). RESULTS: During the study period, thirty non-susceptible isolates (K. pneumoniae n=28, E. coli n=2) were identified in 5 hospitals. Only two of them were confirmed to be carbapenemase producers. A NDM-1-producing K. pneumoniae ST11 was recovered from a patient, transferred from Ukraine, being injured during a Maidan revolution. The second isolate, an OXA-48-producing K. pneumoniae, belonging to ST101, was recovered from a patient admitted to a hospital for an ischemic stroke. CONCLUSIONS: This study again confirmed that the Czech Republic still belongs to the countries with low prevalence of carbapenemase-producing Enterobacteriaceae (CPE). Cases of CPE are usually restricted to an import from high-prevalence countries or countries with unknown epidemiological situation.

• Klíčová slova
• carbapenemase - CPE - MALDI-TOF - susceptibility - resistance - Enterobacteriaceae.,
• MeSH
• antibakteriální látky farmakologie   MeSH
• bakteriální proteiny genetika   metabolismus   MeSH
• beta-laktamasy genetika   metabolismus   MeSH
• Escherichia coli enzymologie   genetika   izolace a purifikace   MeSH
• infekce bakteriemi rodu Klebsiella epidemiologie   mikrobiologie   MeSH
• infekce vyvolané Escherichia coli epidemiologie   mikrobiologie   MeSH
• karbapenemy farmakologie   MeSH
• Klebsiella pneumoniae enzymologie   genetika   izolace a purifikace   MeSH
• lidé MeSH
• mikrobiální testy citlivosti MeSH
• multilokusová sekvenční typizace MeSH
• nemocnice MeSH
• prevalence MeSH
• průřezové studie MeSH
• spektrometrie hmotnostní - ionizace laserem za účasti matrice MeSH
• techniky typizace bakterií MeSH
• zeměpis MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika epidemiologie   MeSH
• Ukrajina MeSH
• Názvy látek
• antibakteriální látky MeSH
• bakteriální proteiny MeSH
• beta-laktamasy MeSH
• carbapenemase MeSH Prohlížeč
• karbapenemy MeSH

Aquatic organisms can be affected not only via polluted water but also via their food. In the present study, we examined bioaccumulation of seventy pharmaceuticals in two benthic organisms, Hydropsyche sp. and Erpobdella octoculata in a small stream affected by the effluent from a sewage treatment plant (STP) in Prachatice (South Bohemia region, Czech Republic). Furthermore, water samples from similar locations were analyzed for all seventy pharmaceuticals. In water samples from a control locality situated upstream of the STP, ten of the seventy pharmaceuticals were found with average total concentrations of 200 ng L(-1). In water samples collected at STP-affected sites (downstream the STP's effluent), twenty-nine, twenty-seven and twenty-nine pharmaceuticals were determined at average total concentrations of 2000, 2100 and 1700 ng L(-1), respectively. Six of the seventy pharmaceuticals (azithromycin, citalopram, clarithromycin, clotrimazole, sertraline, and verapamil) were found in Hydropsyche. Four pharmaceuticals (clotrimazole, diclofenac, sertraline, and valsartan) were detected in Erpobdella. Using evaluation criterion bioconcentration factor (BCF) is higher than 2000 we can assign azithromycin and sertraline as bioaccumulative pharmaceuticals. Even pharmaceuticals present at low levels in water were found in benthic organisms at relatively high concentrations (up to 85 ng g(-1) w.w. for azithromycin). Consequently, the uptake of pharmaceuticals via the food web could be an important exposure pathway for the wild fish population.

• Klíčová slova
• Bioaccumulation, Contamination, Erpobdella, Hydropsyche, Natural fish diet,
• MeSH
• chemické látky znečišťující vodu krev   toxicita   MeSH
• čištění vody * MeSH
• ekosystém * MeSH
• léčivé přípravky analýza   MeSH
• odpad tekutý - odstraňování * MeSH
• odpadní vody chemie   MeSH
• řeky chemie   MeSH
• velkoměsta * MeSH
• vodní organismy účinky léků   MeSH
• zvířata MeSH
• Check Tag
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika MeSH
• velkoměsta * MeSH
• Názvy látek
• chemické látky znečišťující vodu MeSH
• léčivé přípravky MeSH
• odpadní vody MeSH