There are about 9702 clinical studies being (or have been) conducted in Poland. 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.
The purpose of this study is to determine the role of ivabradine in cardiac resynchronization recipients with an unsatisfactory percentage biventricular pacing. The study protocol 60 patients with heart failure NYHA (New York Heart Association) II-IV treated with optimal medical therapy as clinically indicated who received CRT-D device more than 3 months ago. Patients with biventricular pacing <95% will and heart rate <70 at rest and >50% of heart rate in device memory >70 will receive ivabradine. The minimal follow-up of patients in the study will be at least six months.
Background: Psychodynamic and cognitive-behavioral group therapies are frequently applied in day hospitals in the treatment of anxiety disorders, and comorbid depressive or personality disorders in Poland. There is not enough evidence for its effectiveness in this environment. This study addresses this gap. The aim is to determine the effectiveness of the two kinds of day treatments consisting of intensive, short-term group therapy: psychodynamic and cognitive-behavioral for patients with anxiety disorders and comorbid depressive or personality disorders. Our objectives are: 1) Demonstrating effectiveness of each treatment in a day care setting relative to wait-list control; 2) Demonstrating the relative short- and long-term effectiveness of the two active treatments; 3) Preliminary examination of predictors and moderators of treatment response; and 4) Preliminary examination of mediators of therapeutic change; 5) Detailed comparison of impact of both methods of treatment on the outcome of used measures. Methods/design: In this randomized controlled trial, a total of 123 patients with anxiety disorders and comorbid depressive or personality disorders will be assigned to one of three conditions: 1) psychodynamic group therapy; 2) cognitive-behavioral group therapy; 3) waiting list (control group). Therapy will last 12 weeks. Both treatments will be manualized (manuals will address comorbidity). Primary outcome measures are include self-report symptoms of anxiety, observer rated symptoms of anxiety, global improvement and dichotomized diagnosis of anxiety disorder. Secondary outcome measures include personality, depression, self-esteem, defense mechanisms, beliefs about self and others, interpersonal problems, object relations, parental bonding, meta-cognition, mindfulness and quality of life: symptoms of anxiety, depression, personality, self-esteem and defense mechanisms. Measures are taken at baseline, post-treatment and 3 months following the end of the therapy. Discussion: The randomized controlled trial format is used to compare effectiveness of intensive group cognitive-behavior therapy and intensive group psychodynamic therapy for anxiety disorders and comorbid depressive or personality disorders. The rationale is to investigate how effectively anxiety disorders and comorbid personality disorders can be treated in a day hospital typical for Polish healthcare system in 3 months treatment.
The purpose of this study is to compare the outcomes of conventionally fractionated conformal radiotherapy with CF-CRT combined with either high-dose-rate brachytherapy or stereotactic body radiotherapy for intermediate or high-risk prostate cancer patients.
The purpose of this study is to determine whether micronized trans-resveratrol improves clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).
The purpose of this study is to evaluate if the use total marrow irradiation (TMI) as a sole preparation for the first autologous hematopoietic stem cell transplantation (autoHSCT) followed by high-dose melphalan used prior to second autoHSCT is safe and effective in patients with multiple myeloma (MM).
The primary goal of this study by The Polish Adult Leukemia Group (PALG) is to verify if individual therapeutic approach taking into account biological and phenotypic differences as well as response at the level of minimal residual disease is associated with improved outcome of adults with precursor lymphoid neoplasms
The use of oral aCD3 Monoclonal antibody (MAb) alone in subjects with hepatitis C is justified on the basis of scientific and medical reasons. There are data in multiple animal models that aCD3-alone confers efficacy in models of inflammatory or autoimmune disease and induces regulatory T cells and immune-modulation as desired in clinical studies. These observations are reinforced by data in the Phase 1 clinical study showing that aCD3-alone induced the desired immune-modulation in terms of immunological markers for regulatory T cells and appropriate rises and declines in certain cytokine levels.
Finding early predictors of myocardial in patients with hypertension 1. Scientific objective The study objective is to clarify the grounds of heart exertional dyspnoea stenocardial pain in patients with well-controlled stage I or II hypertension according to ESH (European Society of Hypertension), without changes in epicardial coronary arteries in coronary angiography and normal resting echocardiography result, and to assess of potential early markers of heart hypertrophy and failure in patients with hypertension. Characteristics of the final result The study is to allow for identification of patients with hypertension, in whom an early introduction of pharmacological treatment of heart failure should be considered. Evaluation in the detection of asymptomatic myocardial dysfunction will include potential heart failure markers such as: cardiotrophin 1, cystatin C, serum syndecan-4, collagen III N-terminal propetide [PIIINP], MMP-2, MMP-7, MMP-8, MMP-9 and NT-proBNP, modern echocardiography methods and magnetic resonance imaging in order to increase the effectiveness of prevention, diagnosis and treatment optimalization. 2. Project significance Prognosis in heart failure is very serious. It is similar or worse than in advanced cancer. These data indicate an extreme importance of the optimal early causal treatment of hypertension and symptomatic treatment of heart failure early stage in order to prevent the development advanced form of the disease, which has bad prognosis. In clinical practice, patients with well-controlled hypertension often report exercise limitation, exertional dyspnea and/or stenocardial pain which is not reflected in a standard resting echocardiography (normal result), without coronary artery disease data in electrocardiographic stress test and without change in epicardial coronary vessels in coronary angiography. The study is designed to establish the panel of diagnostic tests in patients with hypertension and exertional dyspnoea only, which will allow for early detection of abnormalities (before symptoms occur) and the start of the optimal treatment for these patients. Unfortunately, still too small percentage of patients receives full pharmacotherapy, hence the authors of the latest guidelines of procedure in heart failure and hypertension put great emphasis on this aspect. Optimal management may prevent the progression of these patients in stage C heart failure, and thus bring tangible benefits not only the patients themselves but also, by reducing the number of costly hospitalizations, significantly reduce health care costs. The number of hospitalizations for heart failure in Poland is estimated at 100 000 per year, and hospitalization costs exceed 70% of the total costs associated with the treatment of heart failure. The issue of exertional dyspnoea and overt heart failure in patients with hypertension and normal results of resting echocardiography is a new problem, both in Poland and in the world. So far, there are no treatment recommendations for this group of patients. Material and study plan 120 persons (age 40-60 years old) will be included in the study, patients with stage I or II primary hypertension according to the European Society of Hypertension: Group A- 40 patients without symptoms of heart failure Group B- 40 patients with exertional dyspnoea Group C - 40 patients with overt heart failure In group B (patients with exertional dyspnea/stenocardia) we will include only patients who have undergone contrast coronary angiography without any identified changes in the epicardial coronary arteries, which will facilitate answering the presented purpose of research. Patients in groups A and B with normal resting echocardiography and treated with a maximum of 2 antihypertensive drugs (an ACE inhibitor or a sartan as therapy base), according to the following regimen: ACEI/ARB + diuretic ACEI/ARB + calcium channel antagonist Group C - treatment in accordance with the standards for heart failure. Each patient will be informed about the objectives of the study and give written consent to participate. After signing informed consent patients will have performed the following tests: - Interview and documentation analysis, - Physical examination, - Electrocardiogram, - 24-hour blood pressure monitoring (ABPM), - 24-hour EKG recording, - Echocardiography at rest and during submaxinal exercise on a bicycle ergometer, - Flow-mediated dilatation (FMD), - Cardiac magnetic resonance imaging, - Standard labolatory parameters, - Levels of markers: cystatin C, cardiotrophin-1, metaloproteinases: MMP-2, MMP-7, MMP-8, MMP-9, Procollagen III N-Terminal Propeptide (PIIINP), Syndecan 4 (SDC4) and NT-proBNP Each patient will be informed about the objectives of the study and give written consent to participate.
The principal aim of the study is to demonstrate that Rostafuroxin is able to induce a more pronounced reduction of arterial blood pressure respect to Losartan, in hypertensive patients carrying at least one of the pre-specified gene mutations. In previous studies has been demonstrated that these mutations are able to induce specific alterations inducing an increase of sodium (Na) reabsorption at renal tubular level and an increase of arterial blood pressure. Pilot studies have demonstrated that Rostafuroxin is able to reduce the impact of these alterations, and so directly reverse the increase in blood pressure.
MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and/or with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC/AHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS). Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction. In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE <5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.