There are about 2700 clinical studies being (or have been) conducted in Bulgaria. 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 behaviour of the endometrium during its receptive phase is highly dependent on the endometrial cell type composition. Each cell type has its role in the endometrial preparation for the invading embryo. Alteration in the immune cells dialogue could be the main reason for unsuccessful implantation in certain patients. Immune cell homeostasis is often improved by intrauterine administration of autologous PBMC. There have been numerous reports on the positive effects of the intrauterine administration of autologous PBMC on the IVF outcomes (embryo implantation and ongoing pregnancy success). However, there is little data on the direct effect of the PBMC administration on the cell composition of the endometrium. This study will focus on the changes in the endometrial cell populations by PBMC treatment that could lead to IVF outcome improvement. The aim of this project is to analyze the effect of intrauterine administration of autologous PBMC on the endometrial cell populations and on the IVF outcome parameters (implantation and ongoing pregnancy success as IVF outcome variables).
This study evaluates the safety and efficacy of long-term on-demand treatment with orally administered deucrictibant for acute hereditary angioedema (HAE) attacks, including laryngeal attacks, in patients with HAE due to C1-esterase inhibitor (C1-INH) deficiency (type I/II). The study will enroll patients from Study PHA022121-C201 (NCT04618211) who elect to participate in this extension study and meet the eligibility requirements.
The purpose of this study is to evaluate the long-term safety and efficacy of donidalorsen in people with HAE and the effects of donidalorsen on the number of HAE attacks and their impact on quality of life (QoL).
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.
A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.
A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).
The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.
Background: A Danish study raised the question of the usefulness of escalating energy protocols compared to fixed high-energy protocols. Maximal energies are usually the final choice of the physicians. Some authors showed that decreasing impedance by manual pressure application (MPA) had a positive impact on cardioversion outcome. This is likely due to the impedance decrease linked to MPA. Objective: This new clinical cardioversion study of atrial fibrillation (AF) patients aims to compare the efficacy and safety of a new high energy escalation strategy. The protocol combines high energy shocks at first shock, jumping to maximal defibrillator energy at second shock and finally complemented by MPA at third shock, if success is not reached using electric shocks only. Experimental design: Patients will be recruited at the Intensive Cardiology Care Unit, Cardiology Clinic, National Cardiology Hospital (NCH), Sofia, Bulgaria. All eligible patients will sign a written informed consent prior to the cardioversion and will receive the standard hospital procedures during cardioversion. AF patients will be alternatively randomized to cardioversion using one of the two defibrillators, following the strategy below: DEFIGARD HD-7 arm: 3 consecutive shocks with escalating selected energy: 150J, 200J, 200J. The third shock is combined with MPA LIFEPAK15 arm: 3 consecutive shocks with escalating selected energy: 150J, 360J, 360J. The third shock is combined with MPA The statistical power analysis will consider a superiority comparison between the cumulative energy actually delivered by both defibrillators. The secondary cardioversion efficacy outcome measures are: the cumulative success rate (measured at 1 minute post-shock), number of delivered shocks. Delivered energy will be measured during each shock with a dedicated pulse recording device (approved by the NCH Ethical Committee). Heart rhythm will be measured in continuously recorded peripheral ECG. The secondary cardioversion safety outcome measures are: markers for myocardial necrosis (high sensitive troponin I, CK-MB) evaluated on blood samples taken before and 8-12 hours after cardioversion; ST-segment changes (post-shock - pre-shock) measured in lead II; Complications after cardioversion measured during 2 hours follow-up period in the ICCU - the presence of apnea, arrhythmias, bradycardia and the need for respective therapy at the discretion of attending physician.