There are about 1645 clinical studies being (or have been) conducted in Czech Republic. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice
Caesarean delivery under general anaesthesia (GA) carries nowadays still 25% risk of insufficient depth of anaesthesia in a time before the fetus delivery. The reason is the lack of opioid administration. Opioids easily cross placental barrier and negatively influence newborn postpartum adaptation by respiratory depression. Introduction to GA is thus accompanied by exaggerated autonomic stress reaction with hypertension and tachycardia. The use of ultra-short acting opioid remifentanil should suppress stress response in mother without increasing the risk for newborn. There are only a few clinical data available. This study will be the first one systematically studying the influence of remifentanil in pregnant women with hypertension on hemodynamic stability and newborns safety. This study will also identify potential pharmacogenetic factors of individual variability in remifentanil response with respect of drug efficacy and safety in mother and newborn.
It is known that acute stress of organism often leads to hyperglycemia even in nondiabetic patients. It is also known that pathophysiological mechanisms: enhanced gluconeogenesis, impaired insulin secretion and decreased insulin sensitivity due to anti-insulin effect of stress hormones and proinflammatory cytokines, or changes of glucose excretion and renal tubular resorption. Many studies proved the negative effects of hyperglycemia to different tissues and organs, e.g. hearth (increasing size of myocardial necrosis, reducing coronary collateral blood flow, exaggerating ischemia-reperfusion injury, impairing ischemic preconditioning), vascular (increased risk of thrombosis, endothelial dysfunction, activation of systemic inflammation with destabilization of atherosclerotic plaques), kidneys and its association with infectious complications. The first Leuven study (published in 2001) demonstrated that hyperglycemia in critical care patients significantly increases risk of organ complication and total mortality. Although the importance of postoperative tight glycemia control is now widely accepted, glycemia stability during cardiac surgery is often neglected. It is known that postoperative hyperglycemia has negative effects, but it is not known what effect has its peroperative elevation. Goal of this study is to demonstrate, whether full perioperative intensive glycemia control can reduce the incidence of postoperative morbidity even more than postoperative glycemia control only.
Primary objective: - To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria Secondary objectives: - To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c) - To evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function - To assess the safety and tolerability of study drug - To determine the population pharmacokinetics (PK) of study drug
Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.
PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)
The present study will provide additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images will be analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring will be assessed in Year 2. The results of this open-label study will provide long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.
The aim of the project was to optimalize the process in severe peritonitis which is generally inflicted with high mortality and morbidity with long term costly therapy. Therapy of severe intraabdominal infection consist of treatment of the infection site and following closure of the abdominal cavity with possibility of re-laparotomy and in treatment of complications when needed; or closure introduction of laparostomy with intention to control complications prevention however with risk of tertiary peritonitis. Modern process is laparostomy with active suction (VAC) method which reduces the risk of tertiary peritonitis. It efficacy is however approved especially in therapy of complications. Based on the investigators experiences the investigators use this method even in case of primary treatment of severe peritonitis which led to protocol processing (VAC in case of primary closure of the abdominal cavity; VAC exchange according to scoring system; secondary closure of the abdominal cavity or early coverage with collagen mesh). The aim of this project is to prove reduced mortality, morbidity and hospitalization length (cost reduction) in prospective randomized study in patients treated due to severe peritonitis using VAC method in comparison to classical approach (primary closure of the abdominal cavity; secondary solution of complications).
This is a Natural History study to characterize key aspects of the clinical course of late onset Lysosomal Acid Lipase (LAL) Deficiency/ Cholesteryl Ester Storage Disease (CESD).
Aim of prospective randomized a placebo controlled study is to prove that in case of acute surgical procedure due to appendicitis, ileus of small bowel and perforation of small bowel and stomach appropriately administered antibiotic prophylaxis is effective with lower incidence of infection in surgical site and comparable risk of development of other nosocomial infections versus group without antibiotic prophylaxis. Secondary aim is to determine risk of developing nosocomial infection in the above mentioned group of patients, identify group of patients which does not benefit from prophylaxis, and compile financial costs for antibiotic prophylaxis and treatment of nosocomial infections and thus the background for the recommended procedure with regards that such prospective study does not exist in the Czech Republic.