There are about 1039 clinical studies being (or have been) conducted in Slovenia. 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.
Objectives 1. To characterize mechanical ventilation practices during general anesthesia for surgery 2. To assess the dependence of intra-operative and post-operative pulmonary complications on intra-operative Mechanical Ventilation (MV) settings
The purpose of this study is to determine whether concomitant radiotherapy and trastuzumab (patients treated for early breast cancer) is really safe for the heart even years after treatment and if the investigators should use these two treatments concomitantly without additional harm.
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.
The purpose of the study is to clinically evaluate a new approach to treatment of patients with diabetes mellitus type II by using specially developed mobile-internet software solution. The effect of information and communication technologies (ICT) to improve the integrated care of people with diabetes will be identified, developed, introduced and clinically evaluated. The investigators expect that usage of an e-Health application in health care of patients with diabetes mellitus type II could improve the following healthcare outcomes: results of the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood pressure values, Body mass index (BMI) values, diet, regular exercise and quality of life.
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).
The project's background is the notion that patient centred clinical health promotion has been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO describes health promotion as a key dimension of quality in hospitals, and the organization has developed standards on the topic in order to help hospital management and staff members to assess and improve the quality of health care and thereby achieve better health for patients, staff, and community. Even so, however, health promotion is still a very implicit part of nearly all quality standards on hospitals. Moreover, assessing hospitals departments' health promotion performance is still quite an unexplored area. On this basis, this project will test a new recognition process that uses the relevant WHO-HPH tools and standards to assess performance, by way of explicit documentation and evaluation of clinical health promotion activity. The project is deigned as a RCT, with a control group that undergoes the recognition process immediately and a control group that continue usual clinical routine. Then, after one year, the control group also begins the recognition process (= delayed start), while the Intervention group (=immediate-start) continues with the recognition process. Doing this allows for a great array of measurements, and hopefully the project will then show whether the recognition process really benefits implementation of health promotion in hospitals and health services, and also, if this really generates better health gains for patients and staff. The outcome measurements will be frequency of health promotion services delivered on smoking, excessive alcohol use, overweight, malnutrition, and physical activity to patients in need. Such services could for instance be motivational counselling and brief interventions, as well as intervention, rehabilitation and after treatment. Physical, mental, and social health status among patients and staff will be measured by short form (SF36).
The ideal food for normal infants is human milk. In addition, breast milk has been shown to be a continuous source of commensal, and⁄or probiotic bacteria to the infant gut where they play a key role in the initiation and development of the gut microbiota. Intestinal colonization is essential for maturation of the gut-associated lymphoid tissue (GALT) and the homeostasis of the intestinal epithelium. Colonization begins immediately after birth, while later the composition of the gut microbiota is affected by feeding practices. Results of some studies suggest that long-chain polyunsaturated fatty acids (LCPUFAs) promote the adhesion of probiotics to mucosal surfaces and along with probiotic bacteria contribute to the regulation of innate and adaptive immune responses and present a link among mother's diet, and microbes. The main purpose of the proposed research is to establish the link among mothers' nutrition, human milk LCPUFAs composition and microbiota and their potential influence on child's gut microbiota development. Pregnant women from three different regions of Slovenia will be involved into the study. Dietary intakes will be assessed during pregnancy, at the beginning of the 3rd trimester of pregnancy, and during lactation, at 4 weeks post partum, by 7-day weighed dietary protocol (7DP). Human milk (colostrum, and mature human milk) and infant's faeces will be sampled twice: at 2 or 3rd day post partum (meconium) and at 4 weeks post partum for the determination of human milk LCPUFAs composition and the assessment of human milk (colostrum und mature) and faeces microbiota. The fatty acid composition of human milk will be analysed by capillary gas-liquid chromatography (GC). Microbiota of milk and faeces will be studied using conventional microbiological and modern molecular approach such as qualitative and quantitative PCR amplification of informative genomic regions, DGGE/TGGE and/or t-RFLP and sequencing. Regular monthly meetings with the researchers will be organised for discussion and advising. Basic health parameters of infants will be followed. Data will be gathered from maternity department medical charts, from regular paediatric health care visits and from especially designed health care diary each mother will keep until the end of her child's first year.
The study will evaluate the efficacy and safety of BM32 in grass pollen allergic subjects. It will test the hypothesis that either of two doses of BM32 will lead to a sustained relief off allergy symptoms over a two year study period.
The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.
The investigators study objective is to investigate the effectiveness of vaginal micronized progesterone in prolonging pregnancy after an episode of preterm labor which responded to tocolytic treatment. Furthermore, the investigators aim is to study the mechanisms of actions of progesterone supplementation by examining its effect on the two components of parturition: cervical ripening and myometrial contractility. The investigators will utilize transvaginal ultrasound to assess the changes in the cervical tissue, and non-invasive trans-abdominal uterine EMG to assess the uterine muscle activity. The investigators will also look at the effect of progesterone on contraction frequency by tocodynamometer (TOCO), though EMG is expected to provide much more information.