Medical Research Agency

The aims of the study are: 1. Assessment of the influence of nebivolol on hypertension assessed in ABPM examination and assessment of nebivolol safety in adolescents with hypertension (primary goals) 2. Assessment of the influence of nebivolol on hypertension assessed in oscillometric measurement in adolescents with hypertension, central pressure, parameters of arteries’ functions in adolescents with hypertension, selected biochemical parameters and on the heart rate as well as selected echocardiographic parameters in adolescents with hypertension (secondary goals).

The aim of the project is to evaluate the effectiveness of topical treatment with budesonide in children with Crohn's disease with localization in the esophagus and/or stomach and/or duodenum

The aim of the study is to assess the effect of fenofibrate on the preservation of residual pancreatic beta cell function in children with newly diagnosed type 1 diabetes.

A randomized, double-blind, placebo-controlled, multicentre clinical trial will be conducted. The study will include 102 children aged 10-17 years with newly diagnosed type 1 diabetes, treated at the Department of Pediatrics, MUW University Clinical Centre and at the Department of Endocrinology and Diabetology, Children's Health Institute (IPCZD) in Warsaw. Diabetes mellitus type 1 will be diagnosed in accordance with the criteria of the Polish Diabetes Association.  Children will be randomized to receive fenofibrate orally vs. placebo for one year. The primary endpoint will be to evaluate the function of pancreatic beta cells by comparing the area under the AUC curve in a C-peptide stimulation assay. The secondary endpoints will be: fasting c-peptide concentration and maximum c-peptide concentration in the stimulation test, autoantibodies (GADA, IA2A, ZnT8, IAA), parameters of diabetes control and glucose fluctuations (including HbA1c, mean blood glucose with standard deviation) variability index, time spent in normoglycemia), daily and basal insulin requirements, inflammatory markers.

The aim of the project is to prove whether adding FMT as immunomodulator to the standard treatment in a given centre reduces the risk of COVID19 progression to a higher advancement degree evaluated based on the COVID19 Performance Status scale.

The aim of the project are:

1) to determine the incidence of current and past SARS-CoV-2 infections in a group of police employees, who are particularly exposed to SARS-CoV-2 due to the performed professional duties during the epidemic

2) to determine the factors facilitating SARS-CoV-2 infection in the investigated group; the study will be conducted in a randomized (representative) sample of 5 000 police officers and civil employees from the area of Mazowieckie province

The aim of the presented IMPROVE-MC study is to evaluate the efficacy and safety of 12-month immunosuppressive treatment with prednisone and azathioprine as compared to placebo combined with the standard therapy, in patients with viral negative MSM/inflammatory cardiomyopathy. An additional goal of the project is to develop a diagnostic and therapeutic pattern allowing for modification of MSM treatment guidelines ready for implementation in Polish and international healthcare systems.

The primary objective of the clinical trial will be to assess the frequency of PPHN (persistent pulmonary hypertension of the newborn) defined as the need for ventilation with FiO2> 0.50 and the echocardiographic features of increased pulmonary pressure (right-left or bidirectional shunt through the patent ductus arteriosus) or the need for ventilation with FiO2> 0.50 and the difference in pre- and ductal saturation> 20%) in the treatment of respiratory failure in the group of newborns born between 32 and 41 weeks of pregnancy.

Secondary objectives will be to evaluate in the modified Silverman scale, hereinafter referred to as the "TTN scale" compared to the oxygen concentration used during ventilation and the intervention applied, and to evaluate the parameters of the acid-base balance test: pH, carbon dioxide pressure (pCO2), alkaline deficiency (BE) in compared groups. The study was designed as a prospective, multicentre, randomized, double-blind, placebo-controlled study.

In the study, we want to assess whether the additional administration of Salbutamol shortens the treatment time of a newborn with temporary breathing disorders. After the echocardiographic heart examination is performed, we will know if the newborn has persistent pulmonary hypertension and, using appropriate scales, including the Silverman scale, we will assess the advancement of respiratory disorders. The drug will be administered to the sick newborn for 6 hours, but for a maximum of 72 hours. The study will be performed in eight centres in Poland (Warsaw, Szczecin, Krakow, Poznan, Zielona Gora, Bydgoszcz, Rzeszów, Bytom) under the supervision of outstanding specialists.

We have also invited experts from Canada to participate in the study. We have adopted a hypothesis that the expected effect of the study will be the result according to which Salbutamol administered in nebulisation in respiratory insufficient newborns will reduce the incidence of PPHN, and at the same time will shorten the time of treatment, staying in incubator, separation with mother and frequency of severe complications. We are planning to include in the study a few hundred newborns.

General awarded funds FOR ALL: PLN 14,814,484

General awarded funds MUW ONLY: 3,868,672.5

 

"Research, Project number 2019/ABM/01/00058”, financed by the Medical Research Agency, Poland”

 

The primary aim of the ViRap clinical trial is to compare the safety, tolerance and efficacy of the antiepileptic drug (vigabatrin) and mTOR inhibitor (rapamycin) in epilepsy prevention and mental retardation and autism spectrum disorders in infants with TSC. The secondary goal of the study will be to assess the influence of applying both drugs on the development of nodular changes in children with TSC. The tertiary goal will be the assessment of the influence of the treatment on the biomarkers of epileptogenesis and oncogenesis in TSC.