There are about 5200 clinical studies being (or have been) conducted in Hungary. 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.
This is a Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Multiple Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers and Subjects with MCI or Early AD. In addition, an exploratory study of the effect of a high fat meal was conducted.
Introduction: Septic shock leads to high morbidity and mortality in critically ill patients. Several lower-case scientific studies have supported the synergistic positive effect of vitamin C, thiamine, and hydrocortisone on sepsis-induced organ dysfunction. Aim: Our aim was to investigate the effect of vitamin complex on organ failure, laboratory parameters, respiratory and antibiotic treatment, intensive care time, and mortality in septic shock patients. Material and methods: In our retrospective and prospective analysis, we collected parameters from 43 (23 vitamin-treated, 20 control) septic shock patients. Patients treated with vitamin, they received vitamin C (4x1500 mg), thiamine (2x200 mg) for three days (2). In other respects, and for hydrocortisone (200 mg / 24h), both groups of patients received treatment according to the European Sepsis Recommendation. SPSS (V-21) data were used for data collection, Kolmogorov-Smirnov, Wilcoxon, Mann-Whitney U tests were used for statistical analysis. Ethical license: 7849-PTE 2019.
The study will be a multicenter, randomized, double-blind, follow-up clinical trial. Neither the examining doctor nor the patient knows which capsule they will receive. Just the test unlock the codes after completion. T
Study protocol To prepare for the electrophysiologic study, antiarrhythmic drugs were discontinued at least five half-lives before the procedure and were under conscious sedation using midazolam ± fentanyl while fasting. ICE-guided ablation group In patients randomized to ICE-guided ablation group, catheter placement was initially performed using fluoroscopy guidance, after local anesthesia. A decapolar steerable catheter was placed in the coronary sinus (CS), a quadripolar electrode catheter was positioned in the right ventricular apex and an ablation catheter was inserted to record the His bundle electrogram. Twelve-lead electrocardiogram and intracardiac electrograms were recorded and saved on a digital recording system using a band pass filter of 30 to 500 Hz. Electrical stimulation techniques were used to test atrioventricular nodal conduction and induce AVNRT, with the S2 coupling interval being gradually shortened after each drive-train until tachycardia was induced, AV conduction block occurred, or the atrial refractory period was reached. If tachycardia was not inducible, isoprenaline infusion was given to increase the heart rate by at least 20%, and the same stimulation protocol was repeated during both the infusion and washout phases. The diagnosis of AVNRT was made using established electrophysiologic criteria and pacing maneuvers. This involved assessing the A-(H)-V response after ventricular overdrive pacing, with an SA-VA interval greater than 85 ms, and a corrected postpacing interval minus tachycardia cycle length greater than 110 ms. After confirmation of the diagnosis of AVNRT through the diagnostic EP study, the quadripolar electrode catheter was removed and replaced with an 8F ICE catheter for mapping and SP ablation. The echo-transducer was positioned in the low right atrium at the 6 o'clock position and rotated clockwise towards the septum to allow for visualization of the anatomic landmarks. The proximity of the ablation catheter to the compact AV node was determined by the distance from the aortic valve, which marks the recording site of a proximal His potential. In cases of ineffective ablation, the catheter was moved closer to the aortic valve, but always maintaining a distance of at least 0.5 cm, and RF application was attempted again. RF energy was delivered starting just below the CS with a power output of 30 W and a preset temperature of 55°C. Effective applications were continued for 30 to 60 s and considered successful when junctional rhythm appeared. RF application was immediately halted if there was catheter displacement, sudden impedance rise, prolongation of PR interval, anterograde AV or retrograde VA block. Electroanatomical mapping system -guided ablation group An ablation catheter was inserted into the heart to create an anatomical map by CARTO of the right atrium after local anesthesia, and the location of the His bundle was tagged. Decapolar and quadripolar diagnostic catheters were positioned thereafter into appropriate position as described above. After confirming the diagnosis of AVNRT, mapping of the slow pathway was started by NAVISTAR catheter guided by EAMS and aiming at an atrial-to-ventricular electrogram amplitude ratio of 1:3-1:5. If the ablation endpoint was not reached after 8 radiofrequency (RF) applications, patients in the EMAS-guided ablation group were allowed to crossover to an ICE-guided procedure. The ablation procedure was deemed successful if, following a 20-minute waiting period, the arrhythmia failed to be induced and there were no instances of more than one echo beat observed, both in the presence and absence of isoprenaline. The procedure time was measured from the initial femoral puncture until the withdrawal of the catheters. The mapping plus ablation time was calculated from the start of the SP mapping until the end of the last attempted ablation. Fluoroscopy time, radiation dose, and dose-area product (DAP) were automatically recorded by the fluoroscopy system. The ablation data, including the total number of RF applications, sum of delivered RF energy in Watts, and the total ablation time in seconds, were calculated and stored by the EP recording system (CardioLab, GE Healthcare).
Muscle activity, as a possible fundamental cause of functional limitation, has been extensively investigated in knee osteoarthritis (KOA). Many trials investigated muscle activity during dynamic movements and functional tasks in KOA. In addition, gender-related differences has been also investigated during functional movements in KOA. However, no trial investigated gender-related differences in muscle activation during static movement in KOA.
The goal of this clinical trial is to investigate the efficacy of mindfulness-based cognitive therapy compared to usual care for stroke survivors undergoing inpatient rehabilitation.
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with normal hepatic function.
Our research aimed to investigate how a sedentary lifestyle, body mass index, depression, and stress affect the severity of PMS symptoms and how the listed factors influence each other.
The study is intended to understand the distribution of different obesity classes and obesity related diseases (diseases that present along with obesity) in patients with body mass index (BMI) ≥ 30 kg/m^2. Participants will be asked to give information about their health. They will continue their normal way of life and will not get any medication or additional medical test other than those prescribed to you by their doctor. Participation in the study will last for about 1 day.
This study will be conducted in 2 parts. Part 1 will comprise of participants with mild and moderate HI and matching healthy control participants with normal hepatic function. Part 2 will comprise of participants with severe HI and matching healthy control participants with normal hepatic function. Each study part will comprise of a screening period of up to 28 days, a baseline evaluation on Day -1, and a treatment period including up to 8 days of safety and PK data collection. Participants will be domiciled from Day -1 through Day 8. All participants will receive 25 mg remibrutinib b.i.d. orally on Days 1 and 2, and a morning oral dose of 25 mg remibrutinib on Day 3. PK samples will be collected pre dose on Day 3 and until 72 hours post Day 3 dosing. Throughout the study, safety assessments will include physical examinations, ECGs, vital signs, clinical laboratory evaluations (hematology, chemistry, urinalysis and coagulation) and AE / serious adverse event (SAE) monitoring. The Investigator and Novartis will conduct a joint interim review of safety and PK data from Part 1 before proceeding to Part 2. Part 2 will only begin if administration of remibrutinib in Part 1 is deemed safe and tolerable by the Investigator and Novartis to proceed in participants with severe HI. Depending on the outcome of the interim review, administration of a lower dose of remibrutinib in severe HI participants and their matching healthy control participants may be considered. Part 2 will also include sentinel dosing where one participant with severe HI will receive the first dose of remibrutinib at least 1 week before the remaining participants. If the Investigator concludes that there are no emergent safety concerns for the sentinel participant, then dosing will commence for the remaining participants. Study Completion evaluations will occur on Day 8, followed by a post-study safety follow up contact (e.g. follow-up telephone call, email) approximately 30 days after the last administration of study treatment. The total study duration for each participant is expected to be up to approximately 62 days, including the Screening period and the follow-up contact.