There are about 3133 clinical studies being (or have been) conducted in Romania. 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.
During 2019-2020, the National Oral Health Survey evaluated a significant sample of children aged 5, 6 and 12 years, gathering baseline data on oral health. Data was used to estimate the distribution and severity of dental caries, the need for community-oriented disease prevention and health promotion, and the nature of oral health intervention(s) required. The survey also established how younger age groups can be reached and evaluated. Only 14% of 6 years old children have dmft 0 and the SiC index of the same sample is 9.83. High prevalence of tooth decay with high severity scores, significant inequalities in oral health and poor use and access to services showed the need for a child oral health programme. The originality of the project lies in the vision of using fluoridated toothpaste not only as a means of preventing new carious lesions but also in the therapeutic effect of fluoridated toothpaste, which the study set out to evaluate. This programme could represent an example of good practice for the countries in our region, starting from downstream oral health interventions, such as clinical prevention and oral health promotion, and developing towards upstream interventions. The aim of the project is to improve oral health and reduce inequalities both in dental health and access to dental services by shifting the balance of care towards preventive care. The programme is structured on three levels: 1. Specific training for dental hygienists to deliver oral health promotion to children and nursery educators, focus on tailoring key messages outlined in the care pathway and practical preparation for delivering interventions in nurseries. 2. A toothpaste/toothbrushing scheme involving free daily toothbrushing to every 3 and 4-year old child attending nursery. 3. Provision of clinical prevention activities delivered by dental hygienists for children attending nurseries. The evaluation of the programme consolidates and builds upon previous evaluation work of the National Oral Health Survey for children. Due to the fact that it is a pilot programme aiming to be further implemented at national level, an evolving model of evaluation is appropriate. This allows the evaluation to be responsive to issues emerging from its implementation and develops the programme as a result of the evaluation findings.
This study uses the portal vein pulsatility index (PVPI) to assess fluid intolerance amongst fluid responders.
This study aims to determine if patients with Chronic Obstructive Pulmonary Disease (COPD) exhibit altered muscle properties (specifically changes in tone and stiffness) in both their respiratory muscles and skeletal muscles when compared to healthy individuals. The study will utilize the Myotonometer, a non-invasive device, to assess these properties.
The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).
Chronic obstructive pulmonary disease (COPD) can significantly impact a person's quality of life, not only physically but also mentally. This cross-sectional study aims to assess the psychological well-being of COPD patients by utilising specific questionnaires. These questionnaires will evaluate various aspects of mental health, including anxiety, depression, and potentially other relevant factors like self-compassion or fear of negative evaluation, self-efficacy, shame, and guilt. Additionally, the study will examine how these psychological factors relate to the severity of COPD symptoms, such as dyspnea and functional limitations. By understanding the psychological impact of COPD, this research hopes to emphasize the importance of medical education and mental health support in COPD management strategies.
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.
The incidence of cognitive and neuromotor impairment caused by strokes has become a growing challenge. The patient's journey to recovery in the healthcare system involves multiple phases, spanning from initial hospitalization to in-patient and out-patient rehabilitation, finally leading to the patient's return to home. The access to stroke units and rehabilitation varies within Europe. Unfortunately, not everyone has access to rehabilitation programs, and the benefits derived from these programs often decline after hospital discharge. Currently, the support of the patient is organized in a rather fragmented way, and informal care sometimes places a severe burden requiring dedicated support in the patient's social environment. The PHRASE project proposes to deploy rehabilitation technology such as the Rehabilitation Gaming System (RGS) to instil and support a virtuous cycle of stroke patients' recovery in the at-home setting. RGS is an effective advanced digital tool for rehabilitation programs that uses Augmented Reality (AR)- and Virtual Reality (VR)-based gamified training grounded on neuroscientific principles, that has been shown to promote cognitive and motor recovery after a stroke at the clinic and home. There are many dedicated cognitive therapies, but most rehabilitation outcomes are mostly limited to the task trained and do not extend to day-to-day function or remain unconvincing. Based on recent literature, the PHRASE RGS-based system can provide an effective tool to address cognitive impairment using VR-based interventions. In a previous study, the neuropsychological test battery was compiled by the neuropsychologist and covered four cognitive domains: 1. basic attention, 2. memory (short-term memory), 3. visuospatial memory, and 4. executive function. All these functions were tested using VR-based tasks. The conclusion of this study confirms the possibility of addressing cognitive impairment effectively using VR-based interventions when properly mapped with clinical scales. The validation of the PHRASE system with post-stroke patients is needed to strengthen its usefulness and effectiveness for cognitive rehabilitation at home. For this, a feasibility study will be conducted to measure its usability, adherence, acceptance, and the user's experience. The investigators will also explore the effectiveness of the PHRASE system in improving cognitive function (attention, memory, executive function) after stroke. Participants: stroke patients at different time points after stroke (acute, subacute, and chronic), aged over 18 years. The participants will integrate the PHRASE technology into their daily routines in parallel to their regular neurorehabilitation treatment for 6 weeks.
The purpose of this study is to describe patients' clinical and self-reported outcomes of treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in Romania in real-life setting, up to 6 month of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks (3 months) of treatment with no pre-defined hypothesis.
Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks
The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).