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 extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.
To demonstrate the efficacy of various doses of MED2005 versus placebo in male patients with clinically diagnosed erectile dysfunction, and to evaluate the long-term efficacy and safety (12 months) of MED2005.
CP (cerebral palsy) refers to a group of neurological disorders that appear in infancy or early childhood and permanently affect body movement and muscle coordination. CP is caused by damage to or abnormalities inside the developing brain that disrupt the brain's ability to control movement and maintain posture and balance. The signs of CP usually appear in the early months of life, although specific diagnosis may be delayed until the age of 2 years or older. TEV-50717 (deutetrabenazine, also known as SD-809) has already provided evidence for safe and effective use in 2 other hyperkinetic movement disorders, namely chorea in Huntington's disease (HD) and tardive dyskinesia (TD). Currently, there is no approved treatment available for Dyskinesia in cerebral palsy (DCP). The available treatment options address some of the manifestations of DCP. The study population will include pediatric and adolescent participants (6 through 18 years of age) with DCP with predominant choreiform movement disorder, who have had nonprogressive CP symptoms since infancy (≤2 years of age). Diagnosis of DCP is based on the Surveillance of Cerebral Palsy in Europe criteria. This is a Phase 3 study that will evaluate the efficacy and safety of TEV-50717 administered as oral tablets at a starting dose of 6 mg once daily in participants (age 6 through 18 years, inclusive) with DCP with predominant choreiform movement disorder. The study will be conducted in multiple centers and will use 2 parallel treatment groups (ie, TEV-50717 and placebo) in which participants will be randomized in a 2:1 ratio. "Predominant" in this instance indicates that the choreiform movement disorder is the main cause of impairment or distress.
This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha (TNFα) therapies.
This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. Approximately 150 subjects will be enrolled in this study at about 60 sites in North America, Europe, and Asia. The planned duration of double-blind treatment with study drug is up to 52 weeks.
Investigators would like to examine, what are strategies for balance recovery in gait perturbations. Different perturbation types where used in the current study. The study involves the analysis of kinematic and kinetic parameters. Researchers hypothesize that research including young healthy adults would help to elaborate fall prevention program for seniors.
The main purpose of this study is to determine if an investigational medication called SelK2 works in preventing a condition called "venous thromboembolism" (VTE) in patients having a total knee replacement. SelK2 has been designed to attach to a protein found on blood cells and blood vessels. By attaching to this protein, SelK2 is designed to decrease the inflammatory process in the blood vessel wall that leads to the formation of blood clots in the vessel (called thrombosis). By decreasing the inflammatory process, SelK2 may reduce the risk of VTE following joint replacement surgery. In addition, because SelK2 is not a blood thinner, it is expected that the risk for bleeding will also be reduced.
Aim. To compare changes in cardiac autonomic tone caused by radio-frequency versus cryoballoon ablation and to assess their value in predicting the outcome. Study group. In this prospective randomized study 126 consecutive patients with paroxysmal AF undergoing first ablation of AF using radio-frequency (RF) or cryoballoon (CB) technique will be recruited. Patients will undergo several ECG and autonomic tests before and after the procedure. The follow-up will last one year. Measurements: 1. Standard 12-lead ECG a day before and 1-2 days after the procedure will be performed. The SR and P wave duration as well as the difference (∆) in SR and P wave duration before and after ablation will be analyzed. 2. A 24-hour Holter ECG will be performed at baseline (1-2 days before ablation) and 7-day Holter ECG will be performed 3, 6 and 12 months after the procedure. Minimal, maximal and mean heart rate (HR) as well as HRV parameters will be analyzed. The differences (∆) in these variables between baseline and post-ablation Holter ECG recordings will be analyzed. 3. Autonomic parameters (HR, HRV parameters and baroreceptor reflex sensitivity as well as hemodynamic parameters (stroke volume (SV), cardiac output (CO), total peripheral resistance (TPR)) will be also examined before and after orthostatic stress. This will be performed using tilt table test and non-invasive measurement of autonomic and hemodynamic parameters before and shortly after (1-3 days) the procedure. 4. Quality of life will be assessed using the AFSS scale and EHRA scale at baseline and 3, 6 and 12 months after ablation. 5. Follow-up will last 12 months. Efficacy of ablation will be assessed during outpatients visits and using 7-day Holter ECG recordings 3, 6 and 12 months after the procedure. The analyzed outcomes will include symptomatic recurrences of AF, hospitalizations due to AF, redo procedures i occurrence of asymptomatic AF on Holter ECG monitoring. 6. All the above listed parameters and ablation efficacy will be compared between the RF and CB groups. Anticipated results. 1. Ablation significantly effects the parameters of cardiac autonomic control 2. These effects are more pronounced in the CB group compared with the RF group 3. Changes in autonomic indices have value in predicting ablation efficacy in both analyzed groups.
The aim of the study is the assessment of the effectiveness of medical nutrition therapy (MNT) among obese patients, including a well-balanced low-calories diet, an individual dietary counseling conducted by dietitians and supported by telemedicine (T) or hypnotic suggestions (HS). The study will cover a group of 90 adult patients, both sexes, with obesity (BMI ≥30 kg/m^2) undergoing MNT a dietetic treatment. Three arms are planned in the study scheme, according to the scheme: Group 1 - individual MNT (30 people); Group 2 -individual MNT and T (30 people); Group 3 - individual MNT and HS (30 people). The authors hope that the results of the study will allow to develop a new model of the most effective management of obesity, resulting in weight reduction and maintaining this effect over time. The results obtained during the study will also allow to assess the impact of the therapy applied on lifestyle changes, dietary habits and the knowledge about the disease among obese patients.
To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification [POP-Q] system staging).