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 aim of this study is to compare clinical outcomes of patients with large scars or Cutis laxa treated with injections of autologous stromal vascular fraction cells (SVF) and adipose-derived mesenchymal stem cells (ADSC).
Intravenous lidocaine - a potent local anesthetic with analgesic and anti-inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. In children population promising but limited evidence is available. The study was planned to evaluate the efficacy of continuous intravenous infusion of lidocaine to reduce opioid consumption during and after laparoscopic appendectomy in children.
The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study.
The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.
The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily [QD]) at Week 16 in the treatment of participants with active PsA.
Introduction: The optimal method for the assessment of efficacy of ablation for atrial fibrillation (AF) has not yet been established. The symptom-based evaluation is not accurate because many AF episodes are asymptomatic. It has been well documented that the more frequent and/or longer ECG recording the more the AF recurrences are detected. However, such devices for long-term ECG monitoring as implantable loop recorders are expensive whereas external ECG monitoring is not well tolerated over a period longer than one month. The most frequently used approach is periodic 1-7 day Holter ECG monitoring, usually performed 3, 6 and 12 months after the procedure and additional standard ECG recordings when symptoms occur. Using this method, asymptomatic AF episodes occurring between Holter ECG recordings are missed. Recently, several types of external ECG recorders have been introduced, enabling good quality frequent ECG recordings and transmission via mobile phones. Only a few studies documented the usefulness of this method in detecting silent AF in a high-risk population, however, the value of short but frequent ECG recordings after AF ablation has not yet been established. In these studies, short ECG recordings performer once or twice daily detected the highest number of AF episodes. In summary, data on the optimal type of ECG monitoring after AF ablation are scarce. It seems that frequent, short ECG recordings have more diagnostic yield than 24-hour ECG monitoring, even when performed monthly, or standard care with recording ECG only when symptoms suggesting AF occur. However, the optimal mode of monitoring is not known. Such questions as whether once-a-day ECG transmission is enough and whether longer i.e. 7-day Holter ECG may be as valuable as daily ECG transmissions, remain unanswered. Aim: to compare daily ECG transmissions with repeated 7-day Holter ECG in detecting AF episodes following AF ablation. Hypothesis: daily ECG recordings have significantly higher yield in AF detection than repeated 7-day Holter ECG. Methods: The study group will consists of 50 consecutive patients undergoing AF ablation in the investigator's center. Only patient capable of maintain ISTEL recorder and transmitting ECG will be enrolled in the study (1-2 day after catheter ablation for AF). The follow-up will last 12 months. The AF detection will be performed using two recording methods in each patient. The number of 50 patients has been chosen based on the assumption that Holter ECG will detect AF recurrence in 15% of patients and daily transmission will detect AF recurrence in 38% patients (alfa error = 0.05 and beta error = 0.2). Daily ECG recordings and transmissions will be performed using the HR-2000 recorder (ISTEL, Poland). This device enables recording of 30 seconds of 6-channel ECG (I, II, III, aVR, aVL, aVF) from 4 metal electrodes build in the recorder. In order to record ECG, the device is activated by a patient and attached to the thorax, at the area of sternum. The duration of recording may vary from 30 seconds to 3 minutes, however, only 30-second recordings will be used in the present study. After recording, ECG will be transmitted using Bluetooth to patient's smartphone and then transmitted to the central station where they will be stored and analyzed. Analysis will be performed on a daily basis by an experienced ECG technician, not directly involved in patient's recruitment and treatment. The results of all recordings will be available for study team after 3, 6 and 12 months after ablation, at the time when concurrent Holter ECG recordings will be analyzed. Only in case of serious, life-threatening arrhythmias (non-sustained or sustained ventricular tachycardia, or pauses > 6 seconds) the study team will be informed immediately by a technician about the results of 30-second ECG recording in order to undertake proper action. Specifically, asymptomatic episodes of AF will not be unblinded to the study team in order not to interfere with medication and to allow continuing follow-up till next Holter ECG monitoring. The second method of ECG recording will be 7-day Holter ECG (DMS 300-4A recorders, DM Software, NV, USA) performed 3, 6 and 12 months after ablation. The patients will be allowed to record additional ECG when symptoms suggesting AF occur. This may be performed by ISTEL recorder or standard 12-lead ECG if available. At each time-point (3, 6 and 12 months) the study team will analyze all recorded ECGs and 7-day Holter ECG, and make appropriate therapeutic decisions. Anticipated results: - Daily ECG recordings will detect first AF episode faster than standard Holter monitoring. - ISTEL recorder will identify more patients with AF recurrence than standard Holter monitoring - ISTEL recorder will identify more patients with asymptomatic AF recurrence than standard Holter monitoring Definitions: AF episode - episode lasting ≥30 seconds Study period: August 2018 - August 2020
The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks.. Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.
62 patients age of 20 to 85, (ASA) physical status I-III undergoing laparoscopic nephrectomy/NSS/Hynes Anderson procedures in 1st Department of Anesthesiology in Warsaw will be enrolled in the study. Patients will be randomised into 2 groups - patients from the first group will undergo General Anaesthesia (GA) with intravenous analgesia peri-operatively, patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP block) bilaterally performed under ultrasound guidance with catheter left on the side of surgery. Ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the Th7 spinous process. Three muscles will be identified superficial to the hyperechogenic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 18-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip gets in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. . Patients in this group will be anesthetized with 20ml 0,25% bupivacaine + Adrenaline 1:200 000 for each side. ESP block will be performed at the level of Th7-8 after proper positioning he patient in the sitting position before GA then standard technique of catheter application will be applied. After the surgery the elastomeric pump will be attached to the catheter with 0,125% bupivacaine with Adrenaline 1:200 000. Anaesthesia will be standardised In the both groups.
The clinical data from the clinical trial will be used to assess the performance, sensitivity and specificity of the experimental DualDur In Vitro Diagnostic System.