There are about 6461 clinical studies being (or have been) conducted in Russian Federation. 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.
To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.
To address the question of the comparison of two courses of Vivitrol with differing lengths in 130 HIV negative, consenting, opioid addicted patients who have completed inpatient treatment. Participants will be randomized under double blind conditions to a 24 or 48-week course of pharmacotherapy, along with bi-weekly drug counselling, over 48 weeks, with follow-ups at weeks 60 and 72. The 24-week cohort will receive Vivitrol placebo injections in weeks 24 to 48.
Gastroesophageal reflux disease (GERD) is a chronic condition, which may significantly decrease patients' quality of life due to the typical symptoms - heartburn and regurgitation. These are caused by increasing number of transient lower esophageal sphincter relaxations, regularly recurring reflux of gastric content into oesophagus, acidification of the esophagus and consequent esophageal mucosa damage. In addition, an important role is played by the increase in production of hydrochloric acid in the stomach, the slowdown in the evacuation of the contents from the stomach and increase of gastric and intra-abdominal pressure. All of these factors may depend on the patient's diet. Theoretical premises of the positive influence of including dietary fiber on the course of gastroesophageal reflux disease may be the fact that dietary fiber may absorb nitric oxide (NO) containing in food, which in turn has relaxing effects on the lower esophageal sphincter. In addition, fiber deficiency has been shown to be associated with increased chance of developing hiatal hernia, which is associated with greater risk of the disease manifestations. There is lack of data to confirm that dietary interventions like higher dietary fiber intake may lead to lower frequency of GERD symptoms and influence objective criteria (those, obtained during esophageal pH-impedance (here and further: pH - pondus hydrogenii, i.e. quantity of hydrogen, a scale to measure acidity of a solution) recording and high resolution esophageal manometry). Mucofalk® is a drug of plant origin, consisting of a shell seeds of Plantago ovata (ispaghula, psyllium). High content of mucuses in the composition of psyllium seed allows it to include to group of soft food fibers, which has fundamental value for the appointment of a drug at a number of diseases, when, for example, the use of coarse food fibres not recommended or contraindicated. Mucofalk is the registered medicinal (registration number of the Russian State register of medicines P N014176/01, registration date 14.07.2008, manufacturer: Lozan Pharma Gesellschaft mit beschränkter Haftung (GmbH), packager: Dr. Falk Pharma GmbH, Germany). Recommended dosage and administration: orally, adults and children over 12 years - 1 pack. 2-6 times a day. Before use, the contents of 1 packet poured in a glass, in which slowly poured with cold water (150 ml), stir and drink immediately. Then drink another glass of liquid.
Deep-vein thrombosis (DVT) is a common but under-diagnosed medical condition that occurs when a thrombus forms in one of the large veins, usually in the lower limbs, leading to either partial or complete blocked circulation. The condition may progress to severe health complications, such as pulmonary embolism (PE), if not diagnosed and treated in a timely and effective manner. The goal of the therapy for lower-extremity DVT is to prevent the extension of thrombus and pulmonary embolism in the short term and to prevent recurrent events in the long-term. Although anticoagulant therapy decreases the risk of recurrent thrombosis, the treatment also increases the risk for major hemorrhage. This trial aims to optimize the current medical knowledge on the effectiveness and safety of two low molecular weight heparins, bemiparin and enoxaparin in the treatment of deep vein thrombosis.
Umeclidinium/vilanterol (UMEC/VI) is a combination product under development that is used for the treatment of airflow obstruction in patients with COPD. Fluticasone propionate/salmeterol (FSC) is an approved drug that is already in use for the treatment of COPD. This is a multicenter, randomized, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI 62.5/25 microgram [mcg] once daily administered via Novel Dry Powder Inhaler (NDPI) compared with fluticasone propionate /salmeterol (FSC) 250/50 mcg twice-daily when administered via ACCUHALER/DISKUS inhaler over a treatment period of 12 weeks in subjects with COPD. Eligible subjects will be equally randomized to UMEC/VI 62.5/25 mcg or FSC 250/50 mcg for 12 weeks. A safety follow-up assessment will be conducted approximately 7 days after the end of the study treatment.
The aims of the APRICOT study are: - To establish the incidence of severe critical events in children undergoing anesthesia in Europe. - To describe the differences in paediatric anaesthesia practice throughout Europe. - To study the potential impact of this variability on the occurrence of severe critical events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis, Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and postanaesthetic Stridor).
The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.
This is a 12 month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms, improving physical function and preserving bone structure in patients with active psoriatic arthritis and had inadequate response to a traditional, non-biologic disease modifying anti-rheumatic drug. Adalimumab is use as a comparator.
Primary Objective: To determine the efficacy (as assessed by progression-free survival [PFS]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy. Secondary Objectives: - To determine the efficacy of vandetanib when compared to placebo in this participant population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS). - To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and potentially investigate any influence of participant demography and pathophysiology on vandetanib PK. - To demonstrate an improvement in time to worsening of pain (TWP) in participants treated with vandetanib when compared to placebo in this participant population. - To evaluate the safety and tolerability of vandetanib treatment in this participant population.
THEME RELEVANCE. Sacrococcygeal pilonidal sinus disease (SPD) is a congenital disease that's well spread and constitutes 1-2% of all surgical pathologies. In all Coloproctological pathologies, the disease composes 14-20% (G.I. Vorobjov, 2006; V.D. Fedorov, 2005; Gupta P.J. et al., 2005). Clinical manifestations of pilonidal sinus disease mainly due to the appearance of inflammation in it. The main approach in the complex treatment of this group of patients is to execute radical surgery. The guiding principles in it are adequate sanation and drainage of purulent focus. Despite the fact that this disease is the subject of numerous medical journals, monographs, research works, masters and doctoral theses, frequency of unsatisfactory outcomes remains high (recurrence - from 10% to 19%, wound inflammation - 20-30%). In this case terms of stationary and out-patient treatment increase till 30-70 days (G.I. Vorobjov, 2006; B.M. Dacenko et al., 2004; Cubukcu А., 2001, Perruchoud С, 2002). The frequency of unsatisfactory results after excision of SPD directly depends on the kind of surgery. After palliative surgery (incision and drainage of abscess) in 11.7 - 25.2% of patients occurs recurrence of the disease (McCallum I., King P.M., Bruce J., 2007;), for the open wound healing recurrence occur in 3-8% of the operated. For primary wound healing in 7,5-9,7% required re-surgery (V.K. An, 2003; A.A. Kartashev, 2011). Sacrococcygeal pilonidal sinus disease overwhelmingly affects people, mostly young working age, and treatment failure leads to long-term temporary disability of patients. In the last few years continue to discuss methods of one-time or multi-stage radical surgical treatment of pilonidal sinus, but to date there is no single approach to the choice of surgical treatment for this disease (V.L. Denisenko, 2008). Success of surgical treatment of SPD depends on the development and introduction of new devices and techniques exist to produce convergence and immobilization of the wound edges, thereby obtaining its primary healing and a significant reduction of wound surface. The high frequency of the disease and postoperative complications, as well as long-term temporary disability of patients demonstrates the relevance of the development of modern methods of radical surgery of sacrococcygeal pilonidal sinus disease (V.I. Pomazkin, 2008). AIM OF RESEARCH. The aim of our research is to improve the results of complex radical surgical treatment of patients of sacrococcygeal pilonidal sinus disease through the development and introduction of new devices and techniques for convergence and immobilization wound edges. TASKS OF RESEARCH. 1. To conduct a comparative analysis the most common surgical treatment of SPD in the frequency of complications in the intra- and postoperative periods. 2. To develop a device for convergence and immobilization wound edges in patients with SPD. 3. To analyze the effectiveness of the developed techniques and devices in comparison with traditional surgical treatment. 4. To make practical recommendations on the options and methods of using the developed methods and devices. NOVELTY OF RESEARCH. For the first time, based on the design and creation of an approximation-immobilization device (RU Patent № 112020, Bull. № 1, 01.10.2012) will be improved the surgical treatment of patients with this pathology, clinical and anatomical study of the proposed device for different configurations of gluteal-sacrococcygeal region, as well as the analysis and justification of the basic parameters of wound (length, depth and width of the wound, the number of stitches, the complication rate , the area of the wound). Developed a method of closure of the wound defect after radical excision of pilonidal sinus by Krivonosov-Brezhnev (RU Patent № 2,464,943, Bull. № 30 from 10.27.12.), that significantly reduces the risk of postoperative complications in patients with acute inflammation of the SPD. For the first time an analysis of postoperative period in patients operated with the proposed methods compared with traditional methods of surgery was performed. POSSIBLE APPLICATION AREAS. Results of the research designed for use in the treatment process of coloproctological departments at all levels, as well as the learning process of medical schools. EXPECTED EFFECTIVENESS. 1. Scientific and technical effect: developed new techniques and devices for convergence and immobilization wound edges used for the treatment patients with SPD. 2. Medical and social effects: the introduction into clinical practice of the developed techniques and devices will improve the results of surgical treatment of patients with SPD by rigid fixation of wound edges, by reducing the time of postoperative wound healing, by decreasing the risk of complications in the early postoperative period.